A MANAGEMENT PROGRAM FOR PEOPLE WITH HEART FAILURE … Thuy Ha_Dinh_Thesis.pdf · ii A...

A SELF-MANAGEMENT PROGRAM FOR

PEOPLE WITH HEART FAILURE IN HANOI,

VIETNAM: A CLUSTER RANDOMISED

CONTROLLED TRIAL

Ha Thi Thuy Dinh

Bachelor of Nursing, PhD Candidate

Principal supervisor: Prof Ann Bonner

Associate supervisor: Dr Joanne Ramsbotham

External supervisor: Prof Robyn Clark

Submitted in fulfilment of the requirements for the degree of

Doctor of Philosophy

School of Nursing

Faculty of Health

Queensland University of Technology

2016

A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised controlled

trial i

Keywords

Adult Learning Theory, Chronic Care Model, Heart Failure, Health Education,

Knowledge, Nurse, Teach-back Method, Self-management, Self-care, Readmission,

Vietnam

ii A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised controlled

trial

Abstract

Background: The health care burden of heart failure (HF) is increasing globally.

Heart failure is a chronic syndrome that significantly impacts people’s physical and

psychosocial health, as well as their health-related quality of life. Patients can self-

manage their HF if they are taught how. The evidence from this study shows that

self-management educational programs in HF assists people to recognise their

symptoms, manage them, and respond to symptoms exacerbation. However, patients,

especially aged people and those with lower health literacy, often misunderstand or

incorrectly remember medical information about their diseases and treatment

provided by their health care providers. Thus, patients return home without sufficient

information regarding how to self-care. The teach-back method is known as a tool to

assess and improve patients’ comprehension. This teaching method involves five

steps, and the key step is to ask a person to repeat, in their own words, what the

educator has just taught them. By doing so, the educator is able to recognise the gaps

in the person’s understanding and can provide more explanation regarding those

gaps. The use of teach-back method and HF self-management programs remain

unknown in Vietnam. The aim of this study was to conduct an intervention to teach a

self-management program to people with heart failure, and the teach-back method

was used to assist with delivering the intervention. The results of this study will form

a scientific foundation for further investigation of self-management education to

people with heart failure in health care settings in Vietnam.

Methods: This study was divided into three phases and underpinned by the Chronic

Care Model and Adult Learning Theory. Phase One was a pilot training workshop to

examine the feasibility of teaching HF self-management and the teach-back method


trial iii

to 20 cardiac nurses in Hanoi, Vietnam. This pilot study assessed nurses’ heart

failure knowledge as a learning outcome, and requested their evaluation of the

training contents. The nurses’ evaluation will help to determine whether the HF self-

management and teach-back method is accepted and feasible for use in the

Vietnamese health care context. Phase Two involved translation and linguistic

adaptation, pilot testing with a monolingual expert panel (n = 10), and psychometric

testing of the Vietnamese version of Self-care for Heart Failure Index Scale

(V.SCHFI) in patients with HF (n = 140). Tests of psychometric properties included

internal consistency reliability (Cronbach’s alpha coefficients), content validity

(using content validity indexes [CVI]) and construct validity (using confirmatory

factor analysis to test the structure of the V.SCHFI). Phase Three was a cluster

randomised controlled trial (cRCT) to examine the effectiveness of a self-

management program in HF in a Vietnamese cardiac hospital. Six cardiac wards

from a specialist hospital were randomly allocated to either the intervention or usual

care group. Inclusion criteria were people aged 18-80 years old, fluent in

Vietnamese, and diagnosed with HF (New York Heart Association category II-IV).

To achieve 80% power and allowing for a cluster design effect, 140 participants were

recruited and followed for three months. The participants in the intervention group

received an individual HF self-management educational session using teach-back, in

addition to a HF booklet, diary, weighing scale, and phone call to reinforce the

educational contents. Primary outcomes were changes in HF knowledge (by Dutch

HF Knowledge Scale) and self-care behaviour (by the Self-care for HF Index). The

secondary outcomes will be all-cause hospitalisations and death measured at baseline

and at two follow-up occasions (one and three months).

iv A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised controlled

trial

Results: A total of 20 cardiac nurses attended the Phase One pilot training.

Improvement in mean scores of HF knowledge was found from pre to post-test (12.7

vs 13.8, p < 0.001). The frequency of correct answers increased after the workshop,

particularly some problematic knowledge deficits at baseline (i.e., restricted fluid

amount, cold/flu as the main cause of HF exacerbation). Responses to the evaluation

indicated that nurses valued learning about how to support patients to self-manage

HF, and the teach-back method as a feasible option within their practice.

Phase Two indicated the V.SCHFI was linguistically equivalent to the original, and

had acceptable psychometric properties. Cronbach’s alpha coefficients for the

subscales were 0.47 (self-care maintenance), 0.57 (self-care management), and 0.82

(self-care confidence). All item-level CVIs ranged between 0.87-1, subscale-level

CVIs were between 0.93-1 and the scale-level CVI was 0.96. Confirmatory factor

analysis did not support the model testing a three-component structure of the

V.SCHFI (χ2 = 337.9, CFI = 0.7, RMSEA = 0.08, p = 0.001). CFA was performed

for each subscale. The self-care confidence subscale is reliable and valid (Cronbach

alpha 0.82, excellent CFA fit model). A study with larger sample size is required to

test the CFA for other V.SCHFI subscales.

There were 140 participants from six wards in the cRCT. The results indicated those

who received the self-management program in the intervention group had greater HF

knowledge, averaging 1.6 (95% CI: 1.0- 2.1); greater self-care maintenance (10.3,

95% CI: 6.8 – 13.7); and better self-care management (6.7, 95% CI: 0.9 – 12.3) than

the control group. There was a difference in self-care confidence score in the two

groups; however, the improvement in two groups at end-point was not significant,

compared to baseline score. Hospitalisations or death were compared between the

intervention and control groups in two assumptions: 1) there were no hospitalisation


trial v

or death events in those who were lost-to-follow up; and, 2) there was at least one

cardiac-cause hospitalisation or death occurring in each participant who was lost-to-

follow up. In Assumption 1, at one month cardiac-cause hospitalisation risk ratio

(RR) was 0.8 (95% CI: 0.22 – 2.85, p = 0.73) and, at three months, RR was 0.7 (95%

CI: 0.31 – 0.97, p = 0.59). For Assumption 2, at one month the all-cause

hospitalisation RR was 0.85 (95% CI: 0.59 – 1.23, p = 0.39); at three months, RR

was 1.2 (95% CI 0.75 – 1.51, p = 0.73). There was a trend in the reduction of

hospital readmissions/death in the intervention group compared to the control group;

however, the difference was not statistically significant.

Conclusion: The workshop improved nurses’ knowledge of how to teach HF self-

management and their ability to use the teach-back method in practice. As such,

teach-back is found to be a feasible option for nurses in Vietnam to improve their

practice when delivering patient education. The V.SCHFI is a validated instrument to

measure self-care in Vietnamese speaking people with HF. The V.SCHFI will assist

further studies in Vietnam to improve HF self-care. Health care professionals could

also use the instrument to evaluate whether self-care strategies are effective. The

self-management program was effective in improving HF knowledge and self-care

among people with heart failure. A reduction in hospital readmissions was seen in

the intervention group, but was not significantly different to that in the control group,

warranting further examination.

vi A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised controlled

trial

Table of Contents

Keywords .................................................................................................................................. i

Abstract .................................................................................................................................... ii

Table of Contents .................................................................................................................... vi

List of Figures .......................................................................................................................... x

List of Tables ........................................................................................................................... xi

List of Abbreviations .............................................................................................................. xii

List of Publications ................................................................................................................ xiii

Statement of Original Authorship ......................................................................................... xiv

Acknowledgements ................................................................................................................ xv

Chapter 1: Introduction ...................................................................................... 1

1.1 Introduction .................................................................................................................... 1

1.2 Background .................................................................................................................... 2 1.2.1 Heart failure disease: definition and diagnosis .................................................... 2 1.2.2 Prevalence of heart failure ................................................................................... 4 1.2.3 Self-management program for heart failure ......................................................... 6 1.2.4 The teach-back method ........................................................................................ 8

1.3 Health care context in Vietnam ...................................................................................... 9

1.4 Research objectives ...................................................................................................... 11

1.5 Research questions ....................................................................................................... 11

1.6 Research hypotheses .................................................................................................... 12

1.7 Significance of the study .............................................................................................. 12

Chapter 2: Literature Review ................................................................................. 14

2.1 Introduction ...................................................................................................................... 14

2.2 Risk factors for cardiovascular disease and heart failure ................................................. 14 2.2.1 Hypertension ....................................................................................................... 14 2.2.2 Smoking .............................................................................................................. 15 2.2.3 Physical inactivity ............................................................................................... 16 2.2.4 Diabetes ............................................................................................................... 17 2.2.5 Chronic kidney disease ....................................................................................... 17 2.2.6 Alcohol consumption .......................................................................................... 18 2.2.7 Overweight or obesity ......................................................................................... 18 2.2.8 Stress, anxiety, and depression ............................................................................ 18 2.2.9 Age 19 2.2.10 Gender and ethnicity ......................................................................................... 20 2.2.11 Risk factors for cardiovascular diseases in Vietnam ......................................... 20

2.3 Impact of heart failure on people...................................................................................... 22

2.4 Delivery of chronic disease self-management programs .................................................. 24 2.4.1 Targeted health conditions .................................................................................. 24 2.4.2 Delivery of self-management programs .............................................................. 25 2.4.3 Teaching self-management ................................................................................. 26


trial vii

2.4.4 Settings for self-management programs ..............................................................26 2.4.5 Duration of self-management programs ..............................................................26

2.5 Systematic review: the effectiveness of health education using the teach-back method on

adherence and self-management .............................................................................................27 2.5.1 Introduction..........................................................................................................27 2.5.2 Objectives ............................................................................................................32 2.5.3 Inclusion criteria ..................................................................................................32 2.5.4 Search strategy .....................................................................................................33 2.5.5 Review methods...................................................................................................34 2.5.6 Data extraction .....................................................................................................34 2.5.7 Data synthesis ......................................................................................................35 2.5.8 Results .................................................................................................................35

Identification ...........................................................................................................................36

Screening ................................................................................................................................36

Eligibility ................................................................................................................................36

Included ..................................................................................................................................36

2.6 Identification of gap in research ........................................................................................49

2.7 Chapter summary ..............................................................................................................50

Chapter 3: Theoretical Framework ....................................................................... 51

3.1 Introduction ..................................................................................................................51

3.2 Chronic Care Model .....................................................................................................51 3.2.1 The description of CCM .....................................................................................51 3.2.2 Evidence for the Chronic Care Model ................................................................56 3.2.3 Strengths and limitations of the Chronic Care Model ........................................58

3.3 Malcolm Knowles’ Adult Learning Theory .................................................................60 3.3.1 Adult learning assumptions ................................................................................60 3.3.2 Adult Learning Theory based studies in continuing training for nurses

and people with chronic diseases .......................................................................62 3.3.3 Chronic disease health care in Vietnam .............................................................65 3.3.4 Fit of two theories in this current study ..............................................................66

3.4 Chapter summary ..........................................................................................................68

Chapter 4: Methods ................................................................................................. 69

4.1 Introduction ..................................................................................................................69

4.2 Objectives .....................................................................................................................70

4.3 Research questions........................................................................................................71

4.4 Research hypotheses (H1) .............................................................................................71

4.5 Study design .................................................................................................................72 4.5.1 Phase 1: Training HF self-management and teach-back method to cardiac

nurses: a pilot study using pre and post test design ............................................72 4.5.2 Phase 2: Translation and validation of the Self-care for HF Index v6.2

using Brislin’s Translation Model ......................................................................76 4.5.3 Phase 3: Cluster randomised controlled trial of a self-management

program for Vietnamese people with HF ...........................................................84

4.6 Ethical considerations ...................................................................................................97

4.7 Chapter summary ..........................................................................................................98

viii A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised

controlled trial

Chapter 5: Results .................................................................................................. 100

5.1 Introduction ................................................................................................................ 100

5.2 Results of phase one: the training workshop on HF self-management for nurses ..... 100 5.2.1 Demographic characteristics ............................................................................ 100 5.2.2 Pre-test and post-test results ............................................................................ 101 5.2.3 Workshop evaluation ....................................................................................... 103

5.3 Results of phase two: Brislin’s model translation and validation of the self-care of

heart failure index v6.2 ......................................................................................................... 105 5.3.1 Step 1-3: Translation of the SCHFI ................................................................. 106 5.3.2 Step 4: Content validity of the V.SCHFI ......................................................... 112 5.3.3 Step 5: Psychometric testing of the V.SCHFI ................................................. 113

5.4 Results of phase three: a self-management program for people with heart failure: a

cluster randomised controlled trial ....................................................................................... 126 5.4.1 Data preparation ............................................................................................... 127 5.4.2 Recruitment, group allocation and follow-up .................................................. 128 5.4.3 Baseline characteristics .................................................................................... 130 5.4.4 Characteristics of participants lost to follow-up .............................................. 133 5.4.5 Baseline HF knowledge and self-care scores ................................................... 136 5.4.6 Effects of the self-management program on HF knowledge ........................... 139 5.4.7 Effects of the self-management program on HF self-care ............................... 141 5.4.8 Effect of the self-management program on hospital readmission or death ...... 142

5.5 Chapter summary ....................................................................................................... 146

Chapter 6: Discussion ............................................................................................ 147

6.1 Theoretical framework ............................................................................................... 147

6.2 Phase One: Feasibility of training HF self-management for cardiac nurses .............. 150

6.3 Phase Two: Psychometric properties of the vietnamese version of the self-care for

heart failure index ................................................................................................................. 153

6.4 Phase Three: The effectiveness of a hf self-management program............................ 158

6.5 Chapter summary ....................................................................................................... 169

Chapter 7: Conclusions .......................................................................................... 171

7.1 Introduction ................................................................................................................ 171

7.2 Strengths and limitations ............................................................................................ 171 7.2.1 Strengths of the study ...................................................................................... 171 7.2.2 Limitations of the study ................................................................................... 173

7.3 Implications of the study ............................................................................................ 174 7.3.1 Implications for nursing education and practice .............................................. 174 7.3.2 Implications for health policies ........................................................................ 175 7.3.3 Implications for further research ...................................................................... 176

7.4 Conclusions ................................................................................................................ 177

References ............................................................................................................... 178

Appendices .............................................................................................................. 207

Appendix 1: Medline search strategy ................................................................................... 207

Appendix 2: Mastari Appraisal instruments ......................................................................... 208

Appendix 3: Data extraction tool ......................................................................................... 211


trial ix

Appendix 4: Excluded articles ..............................................................................................213

Appendix 5: Overview of selected articles ...........................................................................215

Appendix 6: JBI Grade of Evidence .....................................................................................220

Appendix 7: Workshop program...........................................................................................221

Appendix 8: Presentation of the HF self-management and the teach-back method .............223

Appendix 9: Copyright permission of “Living everyday with my heart failure” .................234

Appendix 10: Teach-back Observational Tool .....................................................................235

Appendix 11: Demographic questionnaire for nurses ...........................................................236

Appendix 12: Dutch Heart Failure Knowledge Scale ...........................................................237

Appendix 13: Evaluation form for the workshop .................................................................239

Appendix 14: Permission for the Self-care of Heart Failure Index v6.2 ...............................241

Appendix 15: Self-care of Heart Failure Index .....................................................................242

Appendix 16: Assessment tool for panel ..............................................................................244

Appendix 17: Follow-up questionnaire .................................................................................249

Appendix 18: Participants’ demographic questionnaire .......................................................251

Appendix 19: Charlson Comorbidity Index ..........................................................................253

Appendix 20: The Vietnamese version of the SCHFI ..........................................................255

Appendix 21: Ethics approval from Hanoi School of Public Health ....................................258

Appendix 22: QUT Ethics Approval for phase one and phase two ......................................259

Appendix 23: QUT Ethics Approval for the cRCT ..............................................................261

Appendix 24: Letter of approval of Vietnam National Heart Institute .................................263

Appendix 25: Backward translation of the SCHFI ...............................................................264

Appendix 26: Item-level CVIs of the SCHFI items ..............................................................267

Appendix 27: Test of normality ............................................................................................268

Appendix 28: Histogram, normal Q-Q blots and box-whisker plots of variables .................269

Appendix 29: Characteristics of participants who dropped out ............................................276

Appendix 30: Acceptance for presentation in the 1st INC ....................................................279

Appendix 31: Acceptance for presentation in the 2015 JBI Symposium .............................280

Appendix 32: Acceptance for presentation in the 2016 ACNC ............................................281

x A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised controlled

trial

List of Figures

Figure 2.1 Study selection flow chart.................................................................................................... 36

Figure 3.1 Chronic Care Model ............................................................................................................ 52

Figure 3.2 Fit of two theories to the intervention .................................................................................. 67

Figure 4.1 Study phases ........................................................................................................................ 70

Figure 4.2 Translation and validation process....................................................................................... 79

Figure 4.3 Flow chart of the cRCT ....................................................................................................... 85

Figure 4.4 Ward allocation .................................................................................................................... 87

Figure 5.1 Confirmatory factor analysis of the V.SCHFI ................................................................... 122

Figure 5.2 Research process ................................................................................................................ 129


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List of Tables

Table 1.1 Prevalence of heart failure ....................................................................................................... 6

Table 2.1 Quality appraisal of the included articles .............................................................................. 37

Table 4.1 Goodness-of-fit model indices .............................................................................................. 83

Table 5.1 Demographic characteristics ............................................................................................... 101

Table 5.2 Common incorrect answers to the DHFKS ......................................................................... 102

Table 5.3 Evaluation of workshop contents ........................................................................................ 105

Table 5.4 Problematic words and phrases in forward translation process ........................................... 109

Table 5.5 Problematic words and phrase in backward translation process ......................................... 110

Table 5.6 Distortion discovered by supervisory team ......................................................................... 111

Table 5.7 Scale and subscale CVI-Average ........................................................................................ 112

Table 5.8 Social demographic characteristics ..................................................................................... 114

Table 5.9 History of cardiac disease ................................................................................................... 116

Table 5.10 V.SCHFI items responses ................................................................................................. 118

Table 5.11 Internal consistency of the V.SCHFI subscales................................................................. 120

Table 5.12 Goodness-of-fit model indices of the V.SCHFI ................................................................ 121

Table 5.13 Comparison of psychometric properties of the SCHFI in different languages .................. 124

Table 5.14 Social demographic characteristic of two groups .............................................................. 131

Table 5.15 Clinical characteristics ...................................................................................................... 132

Table 5.16 Baseline biochemistry and anthropometric characteristics ................................................ 133

Table 5.17 Reasons for attrition in two groups ................................................................................... 135

Table 5.18 Baseline HF knowledge and self-care scores .................................................................... 136

Table 5.19 Associations of demographic factors to HF knowledge and self-care ............................... 138

Table 5.20 Correlation coefficients of HF knowledge and self-care to age, pro-BNP level,

ejection fraction, and comorbidity index ............................................................................ 139

Table 5.21 Pairwise comparison of knowledge between two groups .................................................. 140

Table 5.22 Pairwise comparison of self-care between two groups ..................................................... 142

Table 5.23 Hospital readmissions or deaths at two follow-up occasions ............................................ 145

xii A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised controlled

trial

List of Abbreviations

BMI Body Mass Index

BNP Beta-type natriuretic peptide

BP Blood Pressure

CCM Chronic Care Model

CFI Comparative Fit Index

CKD Chronic kidney disease

CVD Cardiovascular disease

CVI Content Validity Index

CVI-Average Content Validity Index Average

DHFKS Dutch Heart Failure Knowledge Scale

ETF European Task Force on Heart Failure

HF Heart failure

HRQoL Health-related Quality of Life

I-CVI Item-level Content Validity Index

JBI Joanna Briggs Institute

MASTARI Meta-Analysis of Statistics Assessment and Review Instrument

NYHA New York Heart Association

RCT Randomised Controlled Trial

RMSEA Root-Mean-Square Error of Approximation

SCHFI Self-care for Heart Failure Index

S-CVI Scale-level Content Validity Index

SD Standard Deviation

WHO World Health Organisation


trial xiii

List of Publications

Peer-reviewed publications

1. Dinh, T.T.H., Clark, R., Bonner, A., & Hines, S (2013). The effectiveness of

health education using the teach-back method on adherence and self-

management in chronic disease: a systematic review protocol. JBI Database

of Systematic Reviews & Implementation Reports, 11(10): 30–41.

2. Dinh, T.T.H., Bonner, A., Ramsbotham, .J, Clark, R. (2015). A pilot

education on heart failure self-management and introduction of the teach-

back method to cardiac nurses in Vietnam. Vietnam Journal of Medicine and

Pharmacy, 8(2): 1-10.

3. Dinh, T.T.H., Bonner, A., Ramsbotham, .J, Clark, R., & Hines, S (2016). The

effectiveness of health education using the teach-back method on adherence

and self-management in chronic disease: a systematic review. JBI Database

of Systematic Reviews & Implementation Reports, 14 (1): 210-247.

Conference oral presentations

1. Dinh, T.T.H., Bonner, A., Ramsbotham, .J, Clark, R (2014). A Pilot

Education on Heart Failure self-management and Introduction of the teach-

back Method to Cardiac Nurses in Vietnam. The 1st International Nursing

Conference in Pham Ngoc Thach University, 5-7 December 2014, Ho Chi

Minh city, Vietnam.

2. Dinh, T.T.H., Bonner, A., Ramsbotham, .J, Clark, R., & Hines, S (2015). The

effectiveness of health education using the teach-back method on adherence

and self-management in chronic disease: a systematic review. The 20th

Joanna Briggs Institute Symposium, 4-5 September 2015, Adelaide,

Australia.

3. Dinh, T.T.H., Bonner, A., Ramsbotham, .J, Clark, R (2016). Training

Vietnamese cardiac nurses on Heart Failure self-management and teach-back:

a pilot study. The Annual Australasian Cardiovascular Nursing College

Conference, 4-5 March 2016, Melbourne, Australia.

xiv A self-management program for people with heart failure in Hanoi, Vietnam: A cluster randomised

controlled trial

Statement of Original Authorship

The work contained in this thesis has not been previously submitted to meet

requirements for an award at this or any other higher education institution. To the

best of my knowledge and belief, the thesis contains no material previously

published or written by another person except where due reference is made.

Signature:

Date: 1st November 2016

QUT Verified Signature


trial xv

Acknowledgements

I would like to give my appreciation to all those who supported and contributed to

the completion of this PhD thesis, which will be the most memorable experience in

my study life.

Firstly, I want to give great thanks to Professor Genevieve Gray, the former director

of Vietnam Nursing Project, School of Nursing, who awarded me a scholarship to

start my study journey at QUT. I wish to express my sincere gratitude to my

supervisory team, Professor Ann Bonner, Dr Joanne Ramsbotham, and Professor

Robyn Clark for their high quality supervision, critical comments, encouragement,

and kind support during the course of my PhD study. Without them I would never

have gotten this far.

I would like to thank Dr Martin Reese for his great help in reading my drafts,

listening to my rehearsal, and checking my grammar. Professional editor, Ms Kylie

Morris provided copyediting and proofreading services according to the guidelines

laid out in the university-endorsed guidelines and the Australian Standards for

editing research theses.

I would like to greatly thank to my family, friends, and colleagues who have always

supported me so that I could concentrate on doing my research. Thanks also to the

cardiac nurses, translators, expert panel, and patients in the Vietnam National Heart

Institute who participated in my study.

Chapter 1: Introduction 1

Chapter 1: Introduction

1.1 INTRODUCTION

Worldwide, cardiovascular diseases (CVD) are becoming more prevalent and form

the major proportion of chronic diseases. The World Health Organization (WHO)

reported that an estimated 17.3 million people died from CVDs, representing 30% of

all global deaths (Alwan, 2009). Among these cardiovascular conditions, the

increased number of people with heart failure is an emerging concern for both

developed and developing countries. For instance, Tatsumi et al. (2007) estimated 23

million people were suffering from heart failure in developed countries. The highest

rates of cardiovascular deaths were seen in developing countries in Eastern Europe,

Central Asia, the Middle East, and North Africa (Celermajer, Chow, Marijon,

Anstey, & Woo, 2012). In accordance with therapeutic strategies, self-management

programs are an approach to assist people to manage their own health conditions,

improve health care outcomes, and health-related quality of life. Teach-back is a

method used to assist information providers to assess the understanding of the

recipient. This method requires people to repeat back what they were told, so that

any possible gap or misunderstanding is detected. In this study, a self-management

program adopting the teach-back method was developed for people with heart

failure, with the goal to increase their knowledge of heart failure and self-care.

In this chapter the background, objectives, research questions, and hypotheses of this

study are presented. Furthermore, an overview of heart failure (HF) symptoms and

management is examined, along with the concept of self-management and the teach-

back method. An overview of the following chapters in the thesis is also provided.

Throughout this thesis, the term chronic disease will be used. In addition, people live

2 Chapter 1: Introduction

with a chronic disease such as HF; therefore, the preference in this thesis is to use the

terms person/individual/people rather than patients.

1.2 BACKGROUND

1.2.1 Heart failure disease: definition and diagnosis

Definition

The definition of heart failure (HF) has been changing for decades. Some definitions

used in epidemiological studies are merely based on the clinical criteria. Poole-

Wilson (1987) defined heart failure as a clinical syndrome featuring abnormality of

the structure and function of the heart and a particular pattern of haemodynamic,

renal, and hormonal changes. Packer (1988) then focused on the presence of more

visible symptoms, such as effort intolerance, fluid retention, and reduced longevity.

In 2005, the American Heart Association HF guidelines proposed that heart failure is

a syndrome caused by any structural or functional cardiac disorder that results in the

impairment of the ventricles to fill with or eject blood (Hunt et al., 2005). Adding to

this, the European Task Force on HF (ETF) detailed the symptoms of heart failure,

typically shortness of breath, fatigue, ankle swelling, and objective evidence of

cardiac dysfunction at rest (Hunt et al., 2005). In 2011, the Australian National Heart

Foundation also defined HF as “a complex clinical syndrome with typical symptoms

(dyspnoea, fatigue) that can occur at rest or on effort, and is characterised by

objective evidence of an underlying structural abnormality or cardiac dysfunction

that impairs the ability of the ventricle to fill with or eject blood particularly during

physical activity” (p. 6). It is increasingly accepted that heart failure is confirmed by

the presence of typical symptoms and signs, as well as either structural or functional

abnormalities of the heart. The ETF definition was updated in 2012, and the accepted

definition of HF still acknowledges the occurrence of typical symptoms


(breathlessness, fatigue, ankle swelling) and additionally signs (elevated jugular

venous pressure, pulmonary crackles, and displaced apex beat) resulting from an

abnormality of cardiac structure or function.

Diagnosis

Heart failure is diagnosed on the basis of clinical criteria and requires investigations

to confirm the diagnosis. Symptoms are often first noticed in people with suspected

heart failure (Krum, H. et al., 2011) and these are exertional dyspnoea (orthopnoea

occurs at a later stage), dry cough, fatigue, or heart palpitations. These symptoms

progress in accordance with the deterioration of heart failure. Examination of

physical signs often reveals fluid retention, abnormal vital signs, and the presence of

a third heart sound. These signs require diagnostic investigations to confirm the

clinical diagnosis, cause, and identify treatment and prognosis.

Two common diagnostic investigations, echocardiogram (ECC) and

electrocardiogram (ECG), provide immediate information on heart chamber volume,

ventricular systolic and diastolic function, and valvular function (McMurray et al.,

2012). A measure of natriuretic peptide serum concentration is also required, as this

peptide increases when there is an occurrence of heart problems and is an indicator

of HF exacerbation. The suggested cut-point of B-type natriuretic peptide (BNP) ≥

100 pg/mL and N-terminal pro B-type natriuretic peptide (NT-BNP) ≥ 300 pg/mL

are diagnostic standards of acute events or deterioration of heart failure, while in

non-acute onset the maximum exclusion of these indexes are 35pg/mL and

125pg/mL respectively (Krum, H. et al., 2011). The relative risk of death and

cardiovascular events is doubled at BNP values well below those currently

considered diagnostic for heart failure, at 80-100 pg/mL (Doust, Pietrzak, Dobson, &

Glasziou, 2005). That study also shows that BNP is a strong indicator for the


prognosis of death and cardiac events in people with heart failure (Doust et al.,

2005).

Those individuals who have a history of cardiac conditions are more likely to

develop HF than healthy individuals. Diagnosis of HF can be difficult when

symptoms are non-specific, for example, shortness of breath, dizziness, and fatigue,

or when these symptoms are resolved quickly by medication use. More specific signs

and symptoms are less common and harder to assess (McMurray et al., 2012). The

verification of the presence of HF may be more difficult in obese individuals, older

people, and persons with chronic lung disease (Daniels et al., 2006; Hawkins et al.,

2009; Rutten et al., 2005).

1.2.2 Prevalence of heart failure

The prevalence of HF is rising globally. Approximately 1–2% of the adult population

in developed countries have HF, with the prevalence rising to ≥10% among persons

70 years of age or older (McMurray et al., 2012). More than 23 million people are

estimated to suffer from HF in developed countries worldwide (Tatsumi et al., 2007).

The estimated prevalence of HF is 5.8 million people in the United State (Roger et

al., 2012). Based on data from a study of the Canadian Community Health Survey,

the prevalence of HF in that country is approximately 1% of the population over the

age of 12, and this figure rises sharply after the age of 45, with the

prevalence reported as ranging from 2.2% to 12% (Ammar et al., 2007). In Brazil,

hospital admissions due to HF represent approximately 4% of all hospitalisations,

and 31% of hospitalisations for cardiovascular diseases (Vilas-Boas, 2004).

The prevalence of symptomatic HF in European countries varies from 0.4% to 2%

(Remme & Swedberg, 2001). There are an estimated 15 million Europeans suffering

from this syndrome (Vellone, Riegel, D'Agostino, et al., 2013). In the United


Kingdom, a report suggests that around 800,000 individuals are living with HF,

whereas this figure still does not reflect the real burden of HF stemming from

undiagnosed cases (Townsend et al., 2012).

An increasing trend of HF in the general ageing population is also seen in Australia,

with approximately 2.5% of people aged 55–64 years to 8.2% of those aged 75 years

and over suffering from HF (Selig et al., 2010). Cardiovascular disease remains one

of the leading causes of death in Australia, accounting for 47,637 or 36% of deaths

(Australia Bureau of Statistics, 2006).

Heart failure is also a significant health problem in both developed and developing

Asian countries. A survey in Japan reported an estimated number of more than 1.6

million individuals with HF, which accounted for 15.5% of deaths annually; the

second most common cause of deaths in this country (Tatsumi et al., 2007). An

estimate of1.4 million people with newly diagnosed HF annually was reported in

Southeast Asia (Mathers, Fat & Boerma, 2008). In Singapore, an increase of 9.4%

HF cases has been reported over two years from 2008-2009 (Lee, Khurana, & Leong,

2012). There are an estimated 1.3-4.6 million people with HF and approximately 0.5-

1.8 million newly diagnosed people every year in India (Huffman & Prabhakaran,

2010; Lee et al., 2012). This syndrome also affects 0.9% of the Chinese population

with the prevalence of HF in urban areas higher than in rural areas (1.1% and 0.8%

respectively) (Jiang & Ge, 2009; Lee et al., 2012).

Heart failure in Vietnam

Vietnam’s health profile has recently shown high mortality due to cardiovascular

diseases which accounted for 40% of total deaths (Alwan et al., 2011). Using

Vietnamese population data heart failure prevalence from European countries it is

estimated that 1.8 million people have HF in Vietnam. Van Minh et al (2006)


reported HF ranked second in the group of cardiovascular diseases, and HF

accounted for the most deaths in adults aged 20 years and over between 1999 and

2003 in a Northern district region in Vietnam. Another survey revealed 6.7% among

1,305 people aged 60-95 years old had confirmed HF (T. Pham, 2007). This figure

might be underestimated, as there is a lack of accurate HF screening in the general

population. Table 1.1 summarises the prevalence of heart failure by country.

Table 1.1 Prevalence of heart failure

Country

Prevalence of heart

failure Country

Prevalence of

heart failure

United States

(Roger et al., 2012)

5.8 million Japan

(Tatsumi et al., 2007)

1.6 million

Canada

(Ammar et al., 2007)

2.2%-12% (≥ 45years

old)

Southeast Asia

(Mathers, Fat &

Boerma, 2008)

New 1.4 million

per year

European

(Remme & Swedberg,

2001)

0.4%-2%, around 15

million

India

(Huffman &

Prabhakaran, 2010)

1.3 – 4.6 million

UK

(Townsend et al.,

2012)

Approximately 800,000

people

China

(Jiang & Ge, 2009)

0.9% population

Australia

(Selig et al., 2010)

2.5% aged from 55 – 64

8.2% aged from 75 and

over

1.2.3 Self-management program for heart failure

Chronic health conditions last for a long period, however, most are manageable. The

most effective way of managing a chronic condition is a collaborative interaction

between patients, their physicians, and other health care professionals. This

interaction involves medical management and effective self-management. “Self-

management involves the individual with the chronic disease/condition engaging in

activities that protect and promote health, monitoring and managing the symptoms

and signs of illness, managing the impacts of illness on functioning, emotions and

interpersonal relationships and adhering to treatment regimens” (Von Korff et al.,

1997). According to Lorig, who is one of leading researchers in chronic health


condition self-management, self-management refers to enabling people to “make

informed choices, to adapt new perspectives and generic skills that can be applied to

new problems as they arise, to practice new health behaviours, and to maintain or

regain emotional stability” (Lorig et al., 1993). Self-management is designed to

increase an individual's ability to manage symptoms, treatment, physical and

psychosocial consequences and lifestyle changes inherent in living with a chronic

disease (Barlow, Wright, Sheasby, Turner, & Hainsworth, 2002; Ditewig, Blok,

Havers, & van Veenendaal, 2010; Jovicic, Holroyd-Leduc, & Straus, 2006). Self-

management programs typically focus on symptom recognition and self-monitoring

(Boren, Wakefield, Gunlock, & Wakefield, 2009), medication adherence and

adjustment, diet control, exercise (Boren et al., 2009; Mudge et al., 2011; Smeulders

et al., 2009; Tomita et al., 2008), weight control (Ditewig et al., 2010), blood

pressure control (Ditewig et al., 2010), and reduction in smoking and drinking

(Johnston, Liddy, Ives, & Soto, 2008). These programs have also been adapted for

use in resource scarce settings (Caldwell, Peters, & Dracup, 2005), for people with

low health literacy (DeWalt et al., 2006), older people with HF (Shao, 2008), and

outpatients (Otsu & Moriyama, 2011).

Self-management programs have shown positive impacts in chronic disease care.

Treatment adherence (Jovicic et al., 2006) and quality of life (Ditewig et al., 2010)

have been improved and mortality decreased (Ditewig et al., 2010). A reduction in

hospitalisations and readmission rates has been seen in people with HF (Brady et al.,

2013; Jovicic et al., 2006; Lorig, Sobel, Ritter, Laurent, & Hobbs, 2000), as well as

reduced days in hospital, outpatient visits, and decreased health care utilisation and

costs (Jovicic et al., 2006; Sabaté, 2003) following the introduction of self-

management programs. Immediate outcomes have also improved, such as reductions


in glycosylated haemoglobin levels in diabetic patients, improvement in systolic

blood pressure in diabetics, and fewer exacerbations in asthmatic patients (Warsi,

Wang, LaValley, Avorn, & Solomon, 2004). Heart failure self-management

programs have proven to have positive effects on various outcomes (satisfaction,

learning, behaviour, medications, clinical status, social functioning, mortality,

medical resource utilisation, and cost); 53% of these outcomes showed significant

improvements in at least one study (Boren et al., 2009).

1.2.4 The teach-back method

Teaching self-management to patients has shown benefits; however, the assessment

of patients’ understanding or recall of what they were taught has been paid less

attention. The teach-back method or “closing the loop” is a teaching method used to

ensure patients’ comprehension of information being communicated. The method

involves a process of questioning to determine what individuals have learned from a

health education session, and involves patients being asked to repeat back the key

points of instructions (Jager & Wynia, 2012). Some of the questions could be “Can

you please tell me what we have discussed today?” or “What can you tell your

wife/husband about the changes in your daily diet?”, etc. If there is a gap or incorrect

explanation, the care providers can identify where the information should be

repeated. The cycle continues until individuals answer correctly (Villaire & Mayer,

2007). Teach-back is not a test of the learners’ knowledge, so much as an exploration

of how well the information was taught and what needs to be clarified or reviewed

(Education and follow-up cut heart failure readmissions, 2011). While teach-back

does not require any particular level of health literacy, it allows people with low

literacy levels to actively participate and for information to be reinforced. Teach back


is useful in assisting people to understand treatment regimens and disease warning

signs (Kountz, 2009; Villaire & Mayer, 2007).

An initial review of the literature indicates that teach-back has been used as an

educational strategy for health care professionals (Kornburger, Gibson, Sadowski,

Maletta, & Klingbeil, 2012; Mahramus et al., 2014), low-income women (Wilson,

Baker, Nordstrom, & Legwand, 2008; Wilson, Mayeta-Peart, Parada-Webster, &

Nordstrom, 2012), people with low health literacy (Bowskill & Garner, 2012; Cutilli

& Schaefer, 2011; Kountz, 2009), and people with a chronic disease (Education and

follow-up cut heart failure readmissions, 2011; Howie-Esquivel, White, Carroll, &

Brinker, 2011; Janson, McGrath, Covington, Cheng, & Boushey, 2009). A number of

studies have targeted the use of teach-back in chronic disease education programs to

improve people’s comprehension (Education and follow-up cut heart failure

readmissions, 2011), informed consent (Lorenzen, Melby, & Earles, 2008), and

reduction of readmission (Education and follow-up cut heart failure readmissions,

2011). However, the duration of health education, retention, and the follow-up period

that have incorporated the teach-back method appear to be variable. Most of these

studies have described the use of teach-back as a pilot intervention rather than as

routine practice (Kandula, Malli, Zei, Larsen, & Baker, 2011; White, Garbez,

Carroll, Brinker, & Howie-Esquivel, 2013; Wilson et al., 2008; Wilson et al., 2012).

Therefore, more studies are required regarding teach-back as a method used within

health education sessions.

1.3 HEALTH CARE CONTEXT IN VIETNAM

The provision of care to people with chronic health conditions in Vietnam is

challenging. Disease patterns have been changed in recent years, and there is

increasing frequency of non-communicable lifestyle-related diseases among the


population. Cardiovascular diseases accounted for 40% of total deaths in the country

(Alwan et al., 2011). Cardiovascular diseases and diabetes are responsible for the

highest years of life lost due to premature mortality, and years of healthy life lost due

to disability in Vietnam (Alwan et al., 2011).

In the Vietnamese health care system, most chronic diseases are not screened for at

the community level, hence ill people are often admitted to hospital at late stages of

their disease progression. There is a lack of hospital registration systems, a low

quality of health care services and shortages of qualified staff in regional hospitals;

therefore, patients often choose to present to national hospitals (highest level of

public hospitals). These hospitals always face a heavy burden due to the

overwhelming number of acute presentations, and bed occupancy is often double

(typically more than two patients share one bed, a very common situation throughout

Vietnam).

The daily high level workload of nurses leads them to primarily focus on tasks (e.g.,

administering medications), with patient education a lower priority. Medical

practitioners are viewed as the traditional providers of education to patients, although

brief hospital discharge planning is particularly focused on medication use. In

addition, there is no follow-up assistance from hospitals for people following

discharge and there is a lack of primary health care at community level. Therefore,

patients and their family members must be their own carers, and due to system

shortcomings most of them do not have sufficient understanding of their disease,

treatment, and self-care. The role of nurses in providing self-care education to people

with chronic diseases, and heart failure in particular, requires improvement. Both

cardiac nurses and patients require educational support to improve the quality of

heart failure health care.


1.4 RESEARCH OBJECTIVES

This study provided nurses with the HF self-management knowledge and the teach-

back method as a teaching tool to patients. The study also implemented a self-

management program to people with heart failure. The specific objectives of this

PhD project were to:

1. Examine the feasibility and acceptability of a pilot training workshop on

HF self-management and the use of the teach-back method to teach self-

management in heart failure for cardiac nurses.

2. Translate and validate the Self-care for Heart Failure Index version 6.2

into Vietnamese.

3. Examine the effectiveness of a self-management program using the teach-

back method on HF knowledge for people with heart failure who received

the program.


back method on HF self-care behaviours for people with heart failure who

received the program.


back method on hospital readmissions for people with heart failure who


1.5 RESEARCH QUESTIONS

1. How well did the nurse participants evaluate the training workshops on HF

self-management and the teach-back method?

2. What were the psychometric properties of the Vietnamese version of the

Self-care for Heart Failure Index version 6.2?


3. Was the self-management education program effective in improving HF

knowledge compared to those who received standard care?


self-care compared to those who received standard care?

5. Was the self-management education program effective in reducing number

of hospitalisations compared to those who received standard care?

1.6 RESEARCH HYPOTHESES

In this study, the research hypotheses were:

1. People who receive education via the self-management program will have

greater heart failure knowledge than those who receive standard care.


higher heart failure self-care scores than those who receive standard care.


a lower number of hospital readmissions than those who receive standard

care.

1.7 SIGNIFICANCE OF THE STUDY

Heart failure is becoming more prevalent in the ageing population of Vietnam, which

contributes to a heavier disease burden and potential overload on the health care

system. Self-management programs are an effective approach to assist people to

manage their conditions. Whilst self-management support is considered a focal point

of chronic disease care globally, the effect of implementation of these supports for

people with HF in Vietnam remains unknown. Acknowledging the increasing

prevalence of HF in Vietnamese communities and the limitations of health care

services for these people, there is a need for this study to develop a self-management


program for HF. The use of the teach-back method will facilitate the delivery of the

self-management program by supporting patients to better understand what they are

asked to do.

This study contributes to improving HF care in Vietnam by providing patients with

an understanding of HF and self-management. The study was unique for several

reasons. This was the first time people with HF received educational support to assist

them in self-managing their HF. The intervention particularly addressed people’s

level of understanding and knowledge development. Second, this was the first time

an instrument measuring self-care for heart failure was translated and validated into

the Vietnamese language, enabling measurement of self-care behaviours among

people with HF. The study forms a foundation for further investigations of self-

management in HF, which will contribute to future improvements in HF care in

Vietnam.

14 Chapter 2: Literature Review

Chapter 2: Literature Review

2.1 INTRODUCTION

This chapter presents the risk factors for cardiovascular diseases and the known

impacts on the physical, psychological, and social domains of people who suffer

from the disease. The influence of HF on people’s quality of life is also discussed.

Delivery of self-management programs in chronic diseases and HF are reviewed. The

last section of this chapter is a systematic review on the effectiveness that the teach-

back method has on the adherence to, and improvement in self-care of people with

chronic diseases.

2.2 RISK FACTORS FOR CARDIOVASCULAR DISEASE AND HEART FAILURE

There are many factors associated with increasing risk for cardiovascular diseases

(CVD). The risk factors are typically categorised into modifiable and non-modifiable

risks. Modifiable factors include hypertension, smoking, sedentary lifestyle, diabetes,

chronic kidney disease, alcohol consumption, obesity, and psychological factors.

Non-modifiable factors include age, gender, and family and ethnic background. The

modifiable risk factors are explored first, followed by the non-modifiable factors.

Modifiable risk factors for CVD

2.2.1 Hypertension

Hypertension is an important risk for developing cardiovascular disease.

Hypertension is the biggest risk for coronary heart disease and stroke. Hypertension

is also prevalent in HF patients of all regions and the highest prevalence of

hypertension-related HF was seen in Eastern and Central Europe and Sub-Saharan

Africa (35.0% and 32.6%, respectively), as reported in a systematic review

Chapter 2: Literature Review 15

(Khatibzadeh, Farzadfar, Oliver, Ezzati, & Moran, 2012). Coronary artery diseases

and hypertension are the main causes and risk factors for HF, especially in

individuals aged 65 and over (Drazner, 2011; Dunlay, Weston, Jacobsen, & Roger,

2009). A survey involving 292,000 people in the United Kingdom found that

coronary artery disease was the cause of 52% (95% CI 43–61%) of incidents of HF

in people under 75 years old (Fox et al., 2001). A study in 30 European countries

involving 3,508 people reported coronary diseases and hypertension were the most

common causes in acute HF patients, whereas coronary syndromes accounted for

42% of cases (Nieminen et al., 2006).

2.2.2 Smoking

Smoking is the second leading cause of CVD, after high blood pressure (Mendis,

Puska, & Norrving, 2011). Current smokers have been found to have a higher risk of

HF than non-smokers or past-smokers. Gopal et al (2012) reported that among 2,125

people, the incidence of HF in current smokers was twice that of non-smokers (21.9

and 11.4 per 1000 person-year, respectively). Former heavy smokers (more than 32

pack-year) had higher risk for both HF (adjusted hazard ratio1.45; 95% CI: 1.15-

1.83) and mortality (adjusted hazard ratio 1.38; 95% CI: 1.17-1.64) compared to

never-smokers (Ahmed et al., 2015). People who had used smokeless tobacco had a

moderately higher risk of HF compared with those who had never smoked tobacco

(hazard ratio 2.08 and 1.28 respectively) (Arefalk et al., 2012). Non-smokers who

breathe second-hand smoke have between a 25–30 per cent increase in the risk of

developing a CVD (United State Department of Health and Human Services, 2006).

Individuals who are passive smokers have shown lower reported health-related

quality of life after adjustment of other relevant factors, such as co-morbidities, age,

sex, and medications (Weeks, Glantz, De Marco, Rosen, & Fleischmann, 2011).


Impacts of chemicals in the cigarette smoke to people’s cardiovascular health are

widely proven. Smoking causes an instant and long-term rise in blood pressure, heart

rate, reduce blood flow from the heart, and reduction in the amount of oxygen that

reaches the body’s tissues. Smoking cessation is a recommended part of self-care

interventions in heart failure (Clark, Davidson, Currie, Karimi, Duncan, &

Thompson, 2010). A study has found that after more than 15 years

of smoking cessation, the risk of HF and death for most former smokers becomes

similar to that of never-smokers (Ahmed, et al., 2015).

2.2.3 Physical inactivity

Sedentary lifestyle is also a factor contributing to increased risk of cardiovascular

diseases. The Heart Foundation suggests that physical inactivity is associated with

almost twice the risk of developing coronary heart disease and increased mortality

from myocardial infarction, compared with physically active people (Briffa et al.,

2006). A study analysed the mortality data of 7,744 men, finding an association

between inactive behaviours and increased cardiovascular disease mortality (Warren

et al., 2010). Another review involving eight studies on self-reported sitting and

screen-watching time found that greater sedentary time was associated with an

increased risk of fatal and non-fatal cardiovascular diseases. Compared with people

having the lowest levels of sedentary time, the risk estimates increased to 1.68 times

for people with the highest level of sitting time and 2.25 times for those having the

highest level of screen-watching time. The hazard ratio of cardiovascular disease

increased from 1.01-1.2 times for every two hours of inactivity (Ford & Caspersen,

2012).


2.2.4 Diabetes

Diabetes is also a known important risk factor for CVD. Persons with type 1 or type

2 diabetes are four to 10 times more likely to develop CVD than individuals who are

not diabetic (Leeper, 2011). Diabetes and cardiovascular disease have similar risk

factors and characteristics: increasing with age, obesity, sedentary lifestyle, and can

be reduced by modification of risk factors. The majority of type 2 diabetics have

hypertension and a number of metabolic abnormalities, including increased levels of

low-density lipoproteins and triglycerides, which are risks of heart diseases.

2.2.5 Chronic kidney disease

Chronic kidney disease (CKD) accounts for a high risk and high event rate

of cardiovascular diseases. A systematic review found that a relative risk for

mortality of cardiovascular disease in persons with renal diseases ranged from 1.4 to

3.7 (Tonelli et al., 2006). People with CKD often have typical risk factors for CVD

such as older age, high blood pressure, diabetes mellitus, and physical inactivity

(McCarley & Burrows-Hudson, 2006). In addition, CKD patients have other renal-

related risks for the development of CVD, including anaemia, abnormalities in

mineral metabolism, proteinuria, malnutrition, inflammation, increased C-reactive

protein (Jerome, Claudine, Viola, William, & William, 2003; Sarnak et al., 2003;

Shlipak et al., 2005). Many complications of CKD, if not treated well, will lead to

the worsening progress of kidney diseases and increase cardiovascular morbidity and

mortality (Thomas, Kanso & Sedor, 2008). CKD patients on dialysis have a 10 to 30

times higher CVD mortality compared to individuals at the same age in the general

population (McCarley & Burrows-Hudson, 2006).


2.2.6 Alcohol consumption

Alcohol consumption is a risk factor for the development of HF (Haddad et al., 2008;

Laonigro, Correale, Di Biase, & Altomare, 2009; Skotzko, Vrinceanu, Krueger, &

Freudenberger, 2013). The risk of alcohol intake to HF is influenced by frequency,

quantity of drink and beverage type, age, and health status. People who drink more

than 90g of alcohol every day for five years will be at risk of developing

asymptomatic alcoholic cardiomyopathy, and those patients who continue to drink

may become symptomatic and develop HF (Laonigro et al., 2009). A cohort study

using Cox regression has confirmed that moderate alcohol consumption is associated

with an increased long-term mortality risk in the elderly with the presence of HF

(Gargiulo et al., 2013).

2.2.7 Overweight or obesity

Another factor related to diabetes and cardiovascular diseases is being overweight or

obesity. Obesity is associated with increased risk of myocardial infarction and HF,

and decreased survival chances of cardiovascular patients, particularly in extremely

overweight people. A large meta-analysis of 89 studies has shown hypertension, type

2 diabetes, and cognitive HF were closely related to being overweight (Guh et al.,

2009). This review estimated an incidence rate ratio (95% CI 0.68 - 2.95) of HF

across overweight categories in both men and women (Guh et al., 2009). Multiple

factors contribute to cardiovascular disease in obesity, including insulin resistance,

hypertension, and early coronary artery disease (Apovian & Gokce, 2012;

Mousseaux, 2009).

2.2.8 Stress, anxiety, and depression

Another important cardiovascular-related risk is psychological factors. A meta-

analysis reported that persons with high perceived stress have a risk ratio of 1.27


(95% CI from 1.12 to 1.45) of suffering from coronary heart disease (Richardson et

al., 2012). Studies also suggested an experience of excessive or chronic stress is

associated with other mental disorders, such as depression and anxiety, which can

increase the risk of developing this disease (Saner, 2005; Steptoe & Kivimaki, 2012).

There is evidence that these psychological conditions are prevalent in cardiovascular

patients. A study pointed out that depression is 20% higher in individuals with HF

than healthy people (Khayyam-Nekouei, Neshatdoost, Yousefy, Sadeghi, &

Manshaee, 2013). Another study on hospitalised cardiovascular patients suggested

that rates of depression and anxiety were very high among women (87.5 %) versus

men (55%). People with a longer duration of disease (over six months) seemed to

have higher depression and anxiety scores than those with a shorter duration (Dogar

et al., 2008).

Non-modifiable risk factors for CVD

2.2.9 Age

It is generally known that the prevalence of cardiovascular disease increases with

age. In Australia, during the two years from 2004 to 2005, 13% of those aged 35 to

44 years reported having a cardiovascular condition. This increased to 23% for those

aged 45 to 54 years and 63% for those aged 75 years and over. Of those who had a

cardiovascular disease, 12% also had diabetes, 39% also had arthritis, and 14% also

had a mental and behavioural health problem (Australian Bureau of Statistics, 2006).

Older age is associated with co-morbidities and a natural decline in renal and cardiac

functions. A comprehensive report on the impact of co-morbid conditions in the

elderly with HF discussed the influences of anaemia, cognitive impairment,

depression, and hypertension (Rich, 2005). These age-associated conditions are

likely to influence the development and management of new or established HF.


2.2.10 Gender and ethnicity

Gender and ethnicity also contribute to an increased chance of developing CVD and

HF. A systematic review showed that men have a higher incidence of HF, but the

overall prevalence rate is similar in both genders (Stromberg & Martensson, 2003).

A recent study suggested that even post-menopausal women also have lower risk of

getting heart disease to men (Kim et al, 2015), although oestrogen deficiency after

natural or medically-related menopause is an important risk factor for cardiovascular

disease and coronary artery heart disease (Gorodeski, 2002). In addition, ethnicity

can have influences on a person in terms of their education level, access to health

care, cultural background, socioeconomic status, and stress level. Lower

socioeconomic status, which is associated with an increase of chronic stress, may

lead to heart problems (Benderly, Haim, Boyko, & Goldbourt, 2013; Jiang et al.,

2013; Kristenson, Kucinskiene, Bergdahl, & Orth-Gomér, 2001; Kucharska-Newton

et al., 2011; Sloan et al., 2005). Lower socioeconomic status is also linked to poorer

quality of and unhealthy diet (Gupta et al., 2012; Shahar, Shai, Vardi, Shahar, &

Fraser, 2005) and poorer access to health care and health insurance (Gupta et al.,

2012; Olah, Gaisano, & Hwang, 2013). Research has shown that people with African

and Asian ancestry have a higher prevalence of HF than Caucasians (Moe & Tu,

2010).

2.2.11 Risk factors for cardiovascular diseases in Vietnam

The prevalence of risk factors for cardiovascular diseases has appeared to increase

rapidly in Vietnam. A national survey in Vietnam reported the overweight or obesity

rate (defined as BMI ≥ 25) in both genders was 3.7% in the year 2000 and increased

approximately two fold to 7% in the next five years (2005) (Ha et al., 2011). Another

large study in two Vietnamese provinces, using the same BMI cut-points, found that


there was a fourfold higher prevalence of overweightness and obesity by 2009

(14.5% in males and 17.4% in females) (Q. Nguyen et al., 2012).

An increased trend has also been seen in hypertension. National data on hypertension

prevalence (defined as blood pressure ≥ 140/90 mmHg) was 28.3% and 23.1% in

males and females, respectively, in 2012 (Son et al., 2012). When a cut-off point of

130/85 mmHg was used, the prevalence jumped to 38% in a sample involving males

living in urban areas (Trinh, Nguyen, Phongsavon, Dibley, & Bauman, 2010). In

addition, the use of tobacco and alcohol consumption is also very high in males in

the country. Studies have reported more than 60% of men are current smokers

(ranging from 58% - 68%) (Ahmed et al., 2009; Cuong, Dibley, Bowe, Hanh, &

Loan, 2007; L. H. Pham et al., 2009; Trinh et al., 2010) while between 31% to 39%

of men consumed more than five alcoholic drinks per day (Huu Bich et al., 2009; L.

H. Pham et al., 2009).

Type 2 diabetes is a recent emerging disease in Vietnam. A study revealed that 4.2%

of people in an urban setting had a blood glucose concentration more than 6.1 mmol/l

after an overnight fasting, which indicated the risk of diabetes in these people

(Cuong et al., 2007). Another research team reported a higher prevalence of

confirmed diabetics, with 8% in males and 6.2% in females in two provinces (Q.

Nguyen et al., 2012).

In summary, increased consumption of cigarettes and alcohol, as well as a higher

prevalence of hypertension and diabetes among the Vietnamese population is

contributing to an increasing number of people with cardiovascular problems. A

major number of these risk factors can be modified by changing the environment and

lifestyles. Diagnosis, prognosis, treatment, and self-management of cardiovascular

diseases need to consider modifying the risk factors for each individual.


2.3 IMPACT OF HEART FAILURE ON PEOPLE

People with HF experience a significant impact on the physical, psychological, and

social aspects of everyday life. The physical impacts of HF are due to fatigue (Chen,

Li, Shieh, Yin, & Chiou, 2010; Fink et al., 2012; Jones, McDermott, Nowels,

Matlock, & Bekelman, 2012; Tang, Yu, & Yeh, 2010), chest pain (Clark & Goode,

2013; Goldberg et al., 2010; Goodlin et al., 2012), coughing (Goldberg et al., 2010),

oedema (Kato et al., 2012; Liu et al., 2012), sleep disturbance (Broström, Strömberg,

Dahlström, & Fridlund, 2001; Chen, Clark, Tsai, & Chao, 2009; Johansson et al.,

2012; Norra et al., 2012; Redeker, 2008), appetite loss (Kalantar-Zadeh, Anker,

Horwich, & Fonarow, 2008; Kemp & Conte, 2012; Lennie, Moser, Heo, Chung, &

Zambroski, 2006; Oudejans et al., 2011), and sexual dysfunction (Jaarsma, Koops, &

Van Veldhuisen, 2005).

The impact of HF on the psychological well-being of people is also considerable.

People with HF experience high levels of stress, anxiety, and depression (Chung et

al., 2011; Damen, Pelle, Szabó, & Pedersen, 2012; Evangelista, Ter-Galstanyan,

Moughrabi, & Moser, 2009; Friedmann et al., 2006).

The social impact of HF can be divided into three levels. At a personal level, heart

failure is related to increased social isolation in those with this syndrome (Friedmann

et al., 2006; Hopp, Thornton, & Martin, 2010; Pianese, De Astis, & Griffo, 2011;

Yun-Hee, Kraus, Jowsey, & Glasgow, 2010), their fear and losing a sense of control

(Yun-Hee et al., 2010); relationship difficulty (Pianese et al., 2011), and financial

concern (Biermann et al., 2012; Conard, Heidenreich, Rumsfeld, Weintraub, &

Spertus, 2006; Lee, Chavez, Baker, & Luce, 2004; Liao, Allen, & Whellan, 2008).

At the family level, there is an impact on the quality of life of patients’ partners due

to changes in communication and sexuality (Luttik, Blaauwbroek, Dijker, & Jaarsma,


2007), increasing burden for caregivers, and financial difficulty for the family

(Saunders, 2009). At a social level, health expenditure for HF is a considerable

economic burden on a country (Biermann et al., 2012; Lee et al., 2004; Liao et al.,

2008).

The literature has shown many impacts of HF on people’s lives. Fatigue, reduction in

sleep quality and sexual ability, depression, and feelings of isolation can reduce a

person’s ability to engage in normal social activities, and are also likely to cause a

negative change in a person’s quality of life.

Quality of life (QoL) is associated with the personal levels of happiness and

satisfaction in people’s everyday lives (Fayers, 2000). A study reported that the

number of patients who endured poor QoL due to their health condition was

approximately 30 times the number of patients who died from HF (Tatsumi et al.,

2007). People with HF often experience lower quality of life than those with other

chronic diseases (Riegel & Dickson, 2008), because the disease is likely to influence

the physical, mental, and social aspects of their lives. For instance, the quality of life

of individuals with HF can be severely affected by the reduction in their

independence and ability to undertake certain activities of daily living (Yun-Hee et

al., 2010). In addition, sexual dysfunction, which was seen in 87% of women and

84% of men with heart failure, was associated closely with lower quality of life

(Schwarz et al., 2008; Zeighami Mohammadi, Shahparian, Fahidy, & Fallah, 2012).

Sleep disturbance was also a major problem commonly seen in 56% of participants

in a study; 33% used sleep medication (Erickson et al., 2003). A high prevalence of

co-morbidities in individuals with heart failure contributes to a decrease in the

quality of life (van Deursen et al., 2014). Poorer quality of life may also be due to

inadequate social and care support (Pianese et al., 2011). Among numerous strategic


plans to improve HF treatment and management, patients’ quality of life is still an

issue that is underestimated and considered of less concern.

2.4 DELIVERY OF CHRONIC DISEASE SELF-MANAGEMENT PROGRAMS

Self-management interventions have been provided to people with chronic disease

for assisting in their self-care ability. This section reviews the implementation of

those interventions, including targeted health conditions, the type of course delivery

(group, individual, mixed, or remote), tutor (health care professional, lay, or mixed),

setting (medical, community or occupational), duration (more or less than eight

weeks), and the delivery methods of education used in the self-management

programs.

2.4.1 Targeted health conditions

Self-management programs have been widely implemented for individuals with

chronic health conditions. Most of these conditions are non-communicable and

require people to manage them. Programs targeting self-management have been

conducted in people with heart failure (Armbrister, 2008; Boren et al., 2009; Ditewig

et al., 2010; Smeulders et al., 2009; Tomita et al., 2008), asthma (Janson et al., 2009;

McDonald & Gibson, 2006), diabetes (Jernigan, 2007), and chronic kidney diseases

(Lopez-Vargas, Tong, Sureshkumar, Johnson, & Craig, 2012; Travers, Martin,

Khankhel, Boye, & Lee, 2013). Self-management programs have also been

developed to assist people with other lifestyle-related health conditions, such as

obesity (Goldie & Brown, 2012) and hypertension (Gallagher, de Lusignan, Harris,

& Cates, 2010). Several prolonged health conditions like arthritis (Macfarlane et al.,

2011; Mathews et al., 2007; Palmer, & El Miedany, 2012), musculoskeletal pain

(Carnes et al., 2012) and inflammatory bowel disease (Saibil, Lai, Hayward, Yip, &

Gilbert, 2008) also require patients to self-manage their health. A large number of


studies also target assisting self-management in people with chronic obstructive

pulmonary disease (COPD) (Mitchell et al., 2014; Niesink et al., 2007; Sidhu et al.,

2015; Peytremann-Bridevaux, Staeger, Bridevaux, Ghali, & Burnand, 2008).

2.4.2 Delivery of self-management programs

Self-management programs are provided to people in a variety of ways. The

provision of these courses can be divided into individual, group, remote, or mixed

approaches. Individual self-management has been studied in a population with

asthma applying adult learning principles (Shackelford, 2007). Self-management is

particularly adapted to be individualised or culturally-sensitive to suit people who are

socioeconomically disadvantaged or are low health literate.

Group discussion was the most common way of delivering the self-management

program and has shown better health outcomes compared with routine practice (Liu

et al., 2012; Mash, Levitt, Steyn, Zwarenstein, & Rollnick, 2012; Steinsbekk, Rygg,

Lisulo, Rise, & Fretheim, 2012). A review of 21 studies with 2,833 patients with

diabetes has shown group-based self-management education resulted in significant

improvement in diabetes knowledge, self-management skills, and their self-efficacy

in diabetes after six months, and a reduction of HbA1C and fasting blood glucose at

a 12-month intervention (Steinsbekk et al., 2012).

Remote delivery of self-management is an innovative strategy that employs global

connections through the internet. A variety of approaches have been piloted and

widely implemented, including internet-based programs (Lorig, Ritter, Laurent, &

Plant, 2006; Tomita et al., 2008), and telephone-monitoring (Allen et al., 2010;

Clark, Inglis, McAlister, Cleland, & Stewart, 2007; DiIorio, Reisinger, Yeager, &

McCarty, 2009; Donald et al., 2008; Sperber et al., 2012). Email or post are also used

to support people in self-management programs (Everitt et al., 2013). There is


evidence that these approaches are effective (Handley, Shumway, & Schillinger,

2008), feasible, and acceptable (Farmer, Gibson, Tarassenko, & Neil, 2005).

2.4.3 Teaching self-management

Health care professionals are the traditional providers of self-management education

to patients. In addition, the employment of peer advisers or lay leaders has also

shown positive impacts. A review was systematically undertaken to consider

programs led by lay leaders in chronic diseases that has shown this approach can

improve participants’ self-care self-efficacy, self-rated health, cognitive symptom

management, and frequency of aerobic exercise (Foster, Taylor, Eldridge, Ramsay,

& Griffiths, 2007). More studies are required to assess the long-term outcomes, such

as psychological health, symptoms, or health-related quality of life (Foster et al.,

2007).

2.4.4 Settings for self-management programs

Self-management programs are delivered in many forms, including hospital-based

(Choy et al., 1999; Ninot et al., 2011; Sale, 2011), community-based (Ardeňa et al.,

2010; Choi & Rush, 2012; Effing, Zielhuis, Kerstjens, van der Valk, & van der

Palen, 2011; Shengsheng et al., 2012; Sherifali, Greb, Amirthavasar, Gerstein, &

Gerstein, 2011), and home-delivered (Garcia, 2009; Jerant, Moore-Hill, & Franks,

2009; Shelledy, Legrand, Gardner, & Peters, 2009).

2.4.5 Duration of self-management programs

There is a wide variation in duration for delivery and follow-up of self-management

programs, which depend on program components, resources, and time limitation. A

review of self-management programs on musculoskeletal pain considered studies

conducted for more or less than eight weeks and showed that longer courses did not

necessarily provide better outcomes (Carnes et al., 2012). Improvement in immediate


outcomes normally requires more time. One diabetic self-management program

indicated that knowledge and self-efficacy had improved in six months but improved

blood glucose control required 12 months follow up to show significant

improvement.

In conclusion, there is a large variation in the contents, duration, and follow-up

period, as well as the educators to deliver self-management programs. In this thesis, a

systematic review on the effects of self-management programs using the teach-back

method in improving health care outcomes in chronic diseases is conducted, and is

presented in the next section.

2.5 SYSTEMATIC REVIEW: THE EFFECTIVENESS OF HEALTH EDUCATION USING

;;;;THE TEACH-BACK METHOD ON ADHERENCE AND SELF-MANAGEMENT

Systematic reviews of trials are ranked the highest in the hierarchy of evidence in

health care. The methods of systematic reviews involve comprehensive approaches

in searching studies in a wide range of databases, appraising the study quality and

synthesising the evidence from selected observational and experimental studies. In

this study, a systematic review was conducted to explore how the teach-back method

was used in previous studies involving health education in chronic diseases. The

method of this systematic review adopted the Joanna Brigg Institute (JBI) methods of

appraising and reviewing quantitative studies. This systematic review was published

in the JBI Database of Systematic Review and Implementation Report (Dinh,

Bonner, Clark, Ramsbotham, & Hines, 2016).

2.5.1 Introduction

The prevalence of chronic diseases

Chronic diseases are diseases that last for a long duration and progress slowly.

Chronic diseases are related to multiple causalities and associated factors, are rarely


cured completely, and are likely to lead to health complications and disabilities

(Australian Institute of Health and Welfare, 2012). The World Health Organization

(WHO) reported that nearly 63% of deaths globally were due to chronic diseases,

primarily as a result of cardiovascular, cancer, diabetes, and respiratory conditions

(Alwan, 2011). This mortality is exacerbated in low- and middle-income countries

(Alwan, 2011), and where a high prevalence (80%) of the population over the age of

65 years have three or more chronic diseases (Caughey, Vitry, Gilbert, & Roughead,

2008). People at a greater risk of developing chronic diseases are those who are

older, obese, of low social economic status, or live alone (Walker, 2007). Multiple

chronic diseases have been demonstrated to have considerable negative effects on

peoples’ quality of life (Walker, 2007).

Self-management in chronic disease

Self-management approaches are designed to assist people and their family to better

manage their own chronic disease; and these programs typically focus on symptom

recognition and self-monitoring, medication adherence, diet control, exercise, weight

control, and reduction in smoking and alcohol consumption (Johnston et al., 2008).

These programs have contributed to reductions in hospitalisations, readmission rates

(Brady et al., 2013; Lorig et al., 2001), days in hospital, outpatient visits, health care

utilisation, and costs (WHO, 2003). Compared with standard care, self-management

programs benefit people in terms of knowledge acquisition, performance of self-

management behaviours, self-efficacy, and overall health status (Barlow et al., 2002;

WHO, 2003). Thus, self-management becomes a central point for chronic disease

care (WHO, 2003), and may improve treatment adherence (Jovicic et al., 2006),

quality of life (Ditewig et al., 2010); and reduce heart failure hospitalisations and


readmission rates, days in hospital, outpatient visits, and mortality (Brady et al.,

2013; Jovicic et al., 2006; Lorig et al., 2001).

A common aim of self-management interventions is to increase the active

participation of patients in managing their own health through improving

understanding of their disease (Lorig & Holman, 2003). However, many patients

have difficulty understanding the information delivered by health professionals for

reasons such as low health literacy, and the method and timing of information

delivery. Research suggests that 40-80% of the medical information patients receive

is forgotten immediately; and nearly half of the information retained is incorrect

(Kessels, 2003). People with low literacy and low heath literacy are more likely to

have a poorer understanding of their chronic disease (Villaire & Mayer, 2007).

Clinician-related barriers may include poor communication with patients, lack of

time for consultation, and failure to provide information at a suitable level for patient

understanding (Brunton, 2011). Consequently, there is a need to find effective

educational strategies suitable for people of all literacy levels to help them better

understand their conditions, as well as positively impact their adherence and self-

management.

Current adherence to self-management in chronic disease

Adherence to treatment refers to how patients follow the health care professionals’

advice regarding medication and lifestyle modifications in order to maximise health

care outcomes. Sabaté (2003) suggests that individuals who have good treatment

adherence have fewer complications and disabilities, better quality of life, and

increased life expectancy. In addition, better adherence can prevent other adverse

risks, such as medication side-effects, toxicity from over-use of medication, or

resistance to therapies (Sabaté, 2003). However, non-adherence to treatment


regimens is a common problem for those with chronic disease (Dunbar-Jacob et al.,

2000; Kardas, 2011). A number of studies have reported high rates of non-adherence

ranging from 15-93% depending on the type and number of chronic diseases

(Herriman, 2007), with an estimated average of 50% (Herriman, 2007; WHO, 2003).

There are several consequences of low adherence to long-term therapies, including

poorer health outcomes and increased health care costs (Sabaté, 2003).

The teach-back method for teaching self-management

One method for teaching an individual about their chronic disease and self-

management is called teach-back. Teach-back, also known as “show me” or “closing

the loop”, is a method that aims to increase people’s understanding of the disease

information being communicated in a health education session by asking them to

repeat back key points of the instruction (Jager & Wynia, 2012). The method

includes a process of questioning to determine what understanding the person gained

from the interaction. Examples of the questions include: “Can you please tell me

what we have discussed today” or “What can you tell your wife/husband about the

changes in your daily diet”, etc. If the person responds with an incorrect explanation

or seems to have a gap in understanding, the care providers can identify what

information should be repeated or clarified. The cycle continues until the person

answers correctly (Villaire & Mayer, 2007). In this way understanding is assessed

and health care professionals can identify an education strategy that is commonly

understood by almost all patients. Teach-back is not a test of the person's knowledge

as much as an exploration of how well the information has been taught and what

needs to be clarified or reviewed (Education and follow-up cut heart failure

readmissions, 2011). Because teach-back does not require any particular level of

literacy, it allows those with low literacy levels to actively participate and for


information to be reiterated. Teach-back is useful in assisting patients to understand

treatment regimens and disease warning signs (Kountz, 2009; Villaire & Mayer,

2007).

An initial review of the literature indicates that teach-back has been used as an

educational strategy for health care professionals (Kornburger et al., 2012;

Mahramus et al., 2014), low-income women (Wilson et al., 2008; Wilson et al.,

2012), people with low health literacy (Bowskill & Garner, 2012; Cutilli & Schaefer,

2011; Kountz, 2009), and for patients with a chronic disease (Howie-Esquivel et al.,

2011; Janson et al., 2009). A number of studies have targeted the use of teach-back

in chronic disease education programs to improve a person’s comprehension

(Education and follow-up cut heart failure readmissions, 2011), and informed

consent (Lorenzen et al., 2008) and to reduce hospital readmission (Education and

follow-up cut heart failure readmissions, 2011; Bradke, Brinker, Peter, & Robinson,

2011) although the usefulness of teach-back in improving chronic disease adherence

and self-management has been subjected to less investigation. Moreover, the

duration of health education, retention, and follow-up periods in studies that have

incorporated the teach-back method appears to be variable. Most studies have

described the use of teach-back as a pilot intervention rather than routine practice

(Kandula et al., 2011; White et al., 2013; Wilson et al., 2008; Wilson et al., 2012).

Therefore, this systematic review is necessary to identify evidence regarding the

teach-back method in improving self-management and adherence outcomes for

patients with chronic disease, and to determine how the teach-back method is best

delivered. The methods of this review were specified in advance in a previously

published protocol (Dinh, Clark, Bonner, & Hines, 2013).


2.5.2 Objectives

The objectives of this review were to identify the effectiveness of the teach-back

method in health education on disease-specific knowledge, medication, and care

adherence, and specific self-management skills in adult patients with chronic

diseases.

2.5.3 Inclusion criteria

Types of participants

This review included all studies that involved adult patients (aged 18 years and over)

in any health care setting, either as inpatients (e.g., acute care, medical, and surgical

wards) or those who had attended primary health care, family medical practice,

general medical practice, clinics, outpatient departments, rehabilitation, or

community settings.

Included study participants were those with one or more chronic diseases, including

heart failure, diabetes, cardiovascular disease, cancer, asthma, chronic obstructive

pulmonary disease, chronic kidney disease, arthritis, epilepsy, or a mental health

condition. Studies that included seriously ill patients, and/or those with impairments

in verbal communication and cognitive function were excluded.

Types of intervention(s)

Eligible studies were those that reported the use of the teach-back method alone or in

combination with other supporting educational strategies, either in routine or

research intervention education programs; regardless of how long the programs were,

or whether or not a follow-up was conducted. The intervention could be delivered by

any health care professional. The comparator was any health education for chronic

disease that did not include the teach-back method.


Types of studies

This review considered quantitative studies, including randomised controlled trials,

non-randomised controlled trials, quasi-experimental, case-controlled studies, cohort

studies, and before and after studies that evaluated the effect of teach-back.

Types of outcomes

Selected outcomes were disease-specific knowledge, medication and care adherence,

and specific self-management skills. Secondary outcomes included knowledge

retention, disease-specific self-efficacy, hospital readmission, hospitalisation, and

quality of life. All outcomes were measured using patient self-report scales, nursing

observation, or hospital records.

2.5.4 Search strategy

The search strategy aimed to find both published and unpublished studies. A three-

step search strategy was utilised in this review. An initial limited search of

MEDLINE and CINAHL was undertaken followed by an analysis of the text words

contained in the titles and abstracts to describe articles (see Appendix 1 for the

Medline search strategy example). A second search using all identified keywords

was undertaken across all included databases. Thirdly, the reference lists of all

eligible articles were searched for additional studies. Studies published in English

were considered for inclusion in this review. In order to attain the widest range of

studies, no limits were set for the date of publication. The search was undertaken in

August 2013, and an alert was set up throughout databases to chase newly published

articles.

The databases searched were CINAHL, MEDLINE, EMBASE, Cochrane

CENTRAL Trials register, and Web of Science. A grey literature search was


performed to identify unpublished studies in ProQuest Nursing and Allied Health

Source and Google Scholar.

Initial keywords were “teach-back”, “ask-tell-ask”, “show-me”, “self-management”,

“self-care”, “adherence”, “compliance”, “chronic disease”, and “chronic illness”.

Keywords were combined using Boolean operators such as ‘OR’ and ‘AND’.

2.5.5 Review methods

Two reviewers (HD, AB) independently selected titles and screened abstracts prior to

retrieving full texts. The full-texts were assessed for eligibility in respect to type of

participants, study design, and outcomes. Papers selected for retrieval were assessed

for methodological validity prior to inclusion in the review, using standardised

critical appraisal instruments from the JBI-MAStARI (see Appendix 2). The 10-item

appraisal tool for RCTs and quasi-experimental studies and the nine-item tool for

cohort/case-control or descriptive studies were used. Any disagreements that arose

between the reviewers (HD, AB) were resolved through discussion, or with two other

reviewers (JR, RC).

2.5.6 Data extraction

Two reviewers (HD, AB) independently extracted data from included papers using

an adapted version of the standardised data extraction tool from JBI-MAStARI (see

Appendix 3). The data extracted were participant characteristics (age, gender,

diagnosis, co-morbidity), details of the interventions (teach-back and other

educational components as a standard or intervention care, length of educational

session, follow-up period), and outcomes measured (knowledge, adherence, disease-

specific self-management skills, readmission, knowledge retention, self-efficacy,

quality of life). No disagreements arose between the reviewers (HD, AB) during data

extraction.


2.5.7 Data synthesis

No meta-analysis could be conducted due to clinical heterogeneity in the

interventions, study population, duration of interventions, follow-up, and

measurement scales. Results of measured outcomes are reported in narrative form.

2.5.8 Results

Description of studies

The search of the selected databases generated 5,980 citations. Manual searching of

published systematic reviews and potential articles yielded 10 further articles. After

removing 96 duplicate titles, articles were screened for eligibility and 5,828

discussion papers, editorials, or conference abstracts were removed. Sixty-six

abstracts were screened for eligibility. Of these, 45 abstracts were excluded and 21

articles were retrieved in full texts. Of the 21 studies, 11 were excluded for irrelevant

interventions (did not use the teach-back method) or measured outcomes (for details,

see Appendix 4). Ultimately 10 articles met the inclusion criteria involving

participants with heart failure (n=4), or COPD/asthma (n = 4), or diabetes (n = 2). Of

these, eight were non-randomised/randomised controlled trials, one cohort study, and

one before-after study. No further articles were retrieved from the reference lists of

selected articles. There was no disagreement between reviewers on the selection of

studies. The flowchart of the inclusion process is presented in Figure 2.1.


Figure 2.1 Study selection flow chart

Note. Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., The PRISMA Group (2009). Preferred

Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med

6(6): e1000097. doi:10.1371/journal.pmed1000097

5,980 articles (MEDLINE = 105,

Cochrane CENTRAL = 1, CINAHL

= 35, EMBASE = 7, ProQuest

Nursing and Health Alien = 771,

Web of Science = 59 and Google

Scholar = 5,002

Scr

een

ing

Incl

ud

ed

Eli

gib

ilit

y

Iden

tifi

cati

on

Manual research (n = 10)

5,990 records

66 abstracts were screened

(MEDLINE = 2, CENTRAL = 0,

CINAHL = 1, EMBASE = 0,

ProQuest Nursing and Health Alien

= 6, Web of Science = 15, Google

Scholar = 32, manual search = 10)

45 abstract were excluded

10 articles included for appraisal

using JBI-MAStARI tool

RCT/pseudo-randomised trial = 8,

Cohort = 1, Before and after = 1

11 excluded due to

research design and

irrelevant outcomes

21 articles were reviewed in full texts

9 RCTs, 1 controlled trial, 5

randomized trials, 1 cohort study, 4

before and after studies, one cross-

sectional study

5,894 titles were excluded

96 duplicates


Methodological quality

The results of the quality appraisal are presented in Table 2.1. The majority of

included studies had appropriate sampling, clear inclusion criteria, adequate follow-

up duration, reliable outcome measurement, and analysis. All studies achieved “Yes”

to at least 50% of applicable questions. All assessed studies were considered to be of

sufficient methodological quality for inclusion in the review.

Table 2.1 Quality appraisal of the included articles

First author, year Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10

RCT/pseudo-randomised trial

Bosnic-Anticevich SZ,

2010

Y Y N N U Y Y Y Y Y

Davis, K. K., 2012 U U U U U Y Y Y Y Y

DeWalt, D. A,, 2006 Y Y Y Y N Y Y Y Y Y

Kiser, K., 2012 Y Y Y Y N Y Y Y Y Y

Krumholz, H. M.,

2002

U U U Y Y Y Y Y Y Y

Negaramdeh, R., 2011 Y Y N Y N Y Y Y Y Y

Press, V., 2012 Y Y Y Y Y Y Y Y Y Y

Rydman, R. J., 1999 U U U U Y Y Y Y U Y

% 62.5 62.5 37.5 62.5 37.5 100 100 100 87.5 100

Before – after study

Swavely, D., 2013 NA N NA Y U NA NA Y Y Y

% NA 0 NA 100 0 NA NA 100 100 100

Cohort study

White, M., 2013 N Y U Y NA Y U Y Y ----

% 0 100 0 100 NA 100 0 100 100

Note. Y= Yes; N = No; U = Unclear; NA = Not Applicable. Refer to Appendix 2 for details of

questions 1 – 10.


Characteristics of included studies

Ten studies were included in this review, involving a total of 1,285 people (487

males/738 females). Outcomes measured across the studies were categorised as

disease-specific knowledge (Davis et al., 2012; DeWalt et al., 2006; Negarandeh,

Mahmoodi, Noktehdan, Heshmat, & Shakibazadeh, 2013; Swavely, Vorderstrasse,

Maldonado, Eid, & Etchason, 2013), adherence to medication and diet (Negarandeh

et al., 2013), self-care (Davis et al., 2012; DeWalt et al., 2006; Swavely et al., 2013),

self-efficacy (DeWalt et al., 2006; Swavely et al., 2013), health-related quality of life

(DeWalt et al., 2006), hospital readmission or death (Davis et al., 2012; DeWalt et

al., 2006; Krumholz et al., 2002; Press et al., 2012; White et al., 2013), and

knowledge retention (White et al., 2013). Articles were mostly from United States of

America (Davis et al., 2012; DeWalt et al., 2006; Kiser et al., 2012; Krumholz et al.,

2002; Press et al., 2012; Rydman, Sonenthal, Tadimeti, Butki, & McDermott, 1999;

Swavely et al., 2013), one paper from Australia (Bosnic-Anticevich, Sinha, So, &

Reddel, 2010), and one from Iran (Negarandeh et al., 2013). Studies were conducted

in community pharmacies (Bosnic-Anticevich et al., 2010), academic hospitals

(Davis et al., 2012; DeWalt et al., 2006; Kiser et al., 2012; Press et al., 2012; White

et al., 2013), hospitals (Krumholz et al., 2002), a diabetes clinic (Negarandeh et al.,

2013), an asthma clinic (Rydman et al., 1999) and primary medical practices

(Swavely et al., 2013). Studies were specifically aimed at more disadvantaged

people, including those with mild cognitive impairment (Davis et al., 2012), co-

morbidity (Davis et al., 2012), and low health literacy (DeWalt et al., 2006; Kiser et

al., 2012; Negarandeh et al., 2013). All participants in the studies were adults, the

average age of participants in nine studies was 50 years and over (Davis et al., 2012;

DeWalt et al., 2006; Kiser et al., 2012; Krumholz et al., 2002; Press et al., 2012;


Swavely et al., 2013; White et al., 2013), whereas two specifically targeted people

aged 70 years and over (Krumholz et al., 2002; White et al., 2013).

There was little consistency among studies regarding the delivery methods, duration,

educational components, and persons who conducted the health education programs.

Only one study described the teach-back method as routine care, while other studies

employed the teach-back method as a part of the whole study intervention (Swavely

et al., 2013). Interventions involved educational content delivered with the teach-

back method in one-on-one teaching sessions and during follow-up phone calls

(Davis et al., 2012; DeWalt et al., 2006; Krumholz et al., 2002; White et al., 2013) in

addition to providing participants with self-care tools (weighing scales, pill boxes,

measuring cups) (Davis et al., 2012; DeWalt et al., 2006; White et al., 2013) and

written educational materials (Bosnic-Anticevich et al., 2010; Davis et al., 2012;

DeWalt et al., 2006; Kiser et al., 2012; Krumholz et al., 2002; Negarandeh et al.,

2013; Press et al., 2012; Rydman et al., 1999; Swavely et al., 2013; White et al.,

2013). A patient workbook was used to assist with monitoring a self-care schedule,

medication use, and documenting symptoms (Davis et al., 2012). Three study

interventions focused on educating participants to master a specific task (e.g., inhaler

technique) (Bosnic-Anticevich et al., 2010; Press et al., 2012; Rydman et al., 1999),

while others attempted to increase understanding of the disease state, symptoms, and

self-care. One study used problem based scenarios recorded on audio tape for

participants to review at home as a reinforcement strategy (Davis et al., 2012).

The written educational resources that complimented the teach-back process were

delivered in various forms, e.g., booklets (Davis et al., 2012; DeWalt et al., 2006;

Krumholz et al., 2002) pamphlets (Press et al., 2012), handouts (Kiser et al., 2012)

and product instruction leaflets (Bosnic-Anticevich et al., 2010; Rydman et al.,


1999). Pictograms or visual cues were used in addition to teach-back (Davis et al.,

2012; Negarandeh et al., 2013) as the teach-back interaction occurred in counselling

sessions delivered to participants at home, during hospitalisation (Bosnic-Anticevich

et al., 2010; Davis et al., 2012; DeWalt et al., 2006; Kiser et al., 2012; Negarandeh et

al., 2013; Rydman et al., 1999; Swavely et al., 2013; White et al., 2013), at hospital

discharge (Krumholz et al., 2002), and during follow-up phone calls (Davis et al.,

2012). Education was delivered by nurses (Krumholz et al., 2002; Negarandeh et al.,

2013), case managers (Davis et al., 2012), pharmacists (Swavely et al., 2013),

research assistants (DeWalt et al., 2006; Kiser et al., 2012; Press et al., 2012;

Rydman et al., 1999), and a dietician (Swavely et al., 2013). The educational content

was delivered to participants in single or multiple sessions varying from minutes to

hours. Follow-up varied largely between studies and data collection aimed to detect

changes in short-term outcomes (knowledge, knowledge retention, performance of

self-care skills) and long-term outcomes (readmission, self-care behaviours).

Appendix 5 presents more details regarding selected articles.

Effects of health education using “teach-back” on adherence

Among the 10 studies selected, only one three-arm randomised controlled trial

reported adherence as one of the measured outcomes (Negarandeh et al., 2013). One

hundred and twenty-seven adults with type 2 diabetes who had low health literacy

were randomised to receive routine care (control group) or three weekly educational

sessions, each lasting 20 minutes and delivered with either the teach-back method or

pictorial images (two intervention groups). All participants were followed up for six

weeks. There were significant improvements in both adherence to dietary (3.63

versus 5.87 and 6.15 out of maximum score of 9) and medication regimens (4.32

versus 6.73 and 7.03 out of maximum score of 8) in the control group, the two


pictorial images group, and the teach-back group. All differences in dietary and

medication adherence were statistically significant (p<0.001). The control group also

improved, although a much larger improvement was seen in the two intervention

groups. The differences between end-point and baseline of the adherence to diet and

medication in the teach-back method group were found to be larger than that in the

pictorial images group; however, the difference was not significant.

Effects of health education with “teach-back” on disease-specific knowledge and

knowledge retention

Three RCTs and one before-after study involving a total of 652 participants

measured heart failure (Davis et al., 2012; DeWalt et al., 2006) and diabetes

knowledge (Negarandeh et al., 2013; Swavely et al., 2013). One cohort study with

276 participants measured recall of teach-back questions as the study’s outcome

(White et al., 2013). Disease-specific knowledge was measured at varying follow-up

durations, 30 days (Davis et al., 2012), six weeks (Negarandeh et al., 2013), and six

months later, while knowledge retention was assessed seven days after discharge

from hospital. Studies employed previously validated questionnaires (Davis et al.,

2012; Swavely et al., 2013) and self-developed instruments (DeWalt et al., 2006;

Negarandeh et al., 2013) to measure disease-specific knowledge. Knowledge

retention was measured by the percentage of participants correctly answering at least

three of the four teach-back questions regarding the name of the diuretic medication,

alert at weight gain, avoiding high-salt foods, and warning signs regarding when to

call their health care provider (White et al., 2013).

Four studies (Davis et al., 2012; DeWalt et al., 2006; Negarandeh et al., 2013;

Swavely et al., 2013) reported a significant increase in knowledge scores following

the intervention. Another study found that a larger change in diabetes knowledge

score was seen in groups who received the teach-back method than that in those


educated using pictorial images, although this difference was not significant

(Negarandeh et al., 2013). Swavely et al.’s (2013) study revealed the knowledge

improved significantly, especially in the group with low baseline health literacy. The

reported knowledge retention of participants in White et al.’s study (2013) appeared

to decrease after 7 days post-discharge (84.4% participants answered teach-back

questions correctly during hospitalisation versus 77.1% who answered correctly at

follow-up assessment). Knowledge regarding “avoid high salt foods” and “warning

signs” was seen to be reinforced during follow-up (99.5% answered correctly). This

study raised a notable limitation that a large number of participants missed follow-up

assessment (37.7%), which indicates that the percentage of participants correctly

answering retention questions might be under- or over-estimated (White et al., 2013).

Effects of health education using “teach-back” on disease-specific self-care

Three studies measured self-care behaviour in people with heart failure (Davis et al.,

2012; DeWalt et al., 2006) and diabetes (Swavely et al., 2013) as the study outcomes.

Overall, there was improved self-care in people in the intervention group compared

to the control group, but this was not always significant. One RCT involving 123

heart failure participants found that after 12 months, more people in the intervention

group, who were provided with digital weighing scales, reported daily weight than

the control group (79% versus 29%, p <0.001) (DeWalt et al., 2006). In another

study, self-care behaviours related to diet, exercise, and foot care improved among

participants with diabetes following their participation in the education program (all

p < 0.001) (Swavely et al., 2013). Being able to control blood glucose levels was not

significant (p = 0.345); however, there was a trend towards improvement. Another

study reported that those with heart failure with mild cognitive impairment showed

improvement in self-care levels in both intervention and control groups; however,


this change was not statistically significant (Davis et al., 2012). In this study, the

effect of the intervention was assessed at 30 days post-intervention, and this might

not have provided sufficient time to demonstrate self-care behaviour change.

Moreover, the majority of participants had multiple chronic conditions (82% in

control and 86% in intervention), which may have impacted on self-care capacity

(Davis et al., 2012). The influence of co-morbidity on self-care ability was not

investigated in this study.

Four studies (Bosnic-Anticevich et al., 2010; Kiser et al., 2012; Press et al., 2012;

Rydman et al., 1999) reported improved patient skill with the use of an inhaler

device in favour of the intervention group. Correct inhaler device use was seen in the

intervention group earlier than in the control group (at visit two versus visit four post

education) (Bosnic-Anticevich et al., 2010). In another two studies, the inhaler

device technique improved significantly in both the intervention and control groups

(Press et al., 2012; Rydman et al., 1999). Additionally, the rate of inhaler device

misuse was reduced significantly after receiving either teach-back or verbal

instructions regardless of the study group (Press et al., 2012).

Effects of health education using “teach-back” on hospital readmission and

hospitalisation

Five studies involving people with heart failure (Davis et al., 2012; DeWalt et al.,

2006; Krumholz et al., 2002; White et al., 2013) and COPD/asthma (Press et al.,

2012) measured readmission and hospitalisation as study outcomes. Generally, less

readmission and hospitalisation was seen in the intervention groups, although they

were not always statistically significant. Krumholz et al. (2002) reported a 39%

reduction in the all-cause hospital readmission rate in the intervention group

compared with that of the control group (p=0.06), while cardiac-cause readmission

was significantly reduced in the intervention group (RR: 0.63, 95% CI: 0.46, 0.86).


Another study showed a low heart failure-related readmission rate of 3.3% among

276 participants during 12 months follow-up (White et al., 2013). This study also

found that participants who answered teach-back questions correctly after hospital

discharge did not show a significant difference in readmission rates to those who

answered incorrectly. Fewer hospitalisation events were also seen in the intervention

participants, although a significant difference to those in control group was not

detected (Davis et al., 2012; Krumholz et al., 2002; Press et al., 2012). These studies

indicate that a reduction in readmission rates or hospitalisations might be a promising

outcome for studies with the teach-back method, although further explorations are

required to provide stronger evidence.

Effects of health education using “teach-back” on health-related quality of life

(HRQoL)

Only one study involving people with heart failure (n=123) reported HRQoL as a

study outcome (DeWalt et al., 2006). There was no significant improvement in

HRQoL, measured by the Minnesota Living with Heart Failure Questionnaire in

either the intervention or control group after a follow-up at 12 months. After

adjusting for baseline differences between two groups, the mean difference in

HRQoL was two points (95% CI 9, -5, p=0.59). Therefore, the estimate of the

interventions involving the teach-back method on improved HRQoL remained

unknown.

Effects of health education using “teach-back” on disease-specific self-efficacy

Two studies reported self-efficacy as a study outcome (DeWalt et al., 2006; Swavely

et al., 2013). There was a significant improvement in self-efficacy scores in favour of

those in the intervention groups in both studies. In one study using the eight-item

self-developed self-efficacy instrument (score from 0-24), the mean difference in

self-efficacy score improved by two points at the end of the study (95% CI 0.7, 3.1,


p=0.0026) (DeWalt et al., 2006). Another study measuring the outcome using the

Stanford Diabetes Self-Efficacy Tool score of 1-10, reported a significant

improvement in mean self-efficacy scores from baseline and at the end of the

program (6.59 versus 8.47 respectively, p< 0.001) (Swavely et al., 2013). These two

studies indicate that using the teach-back method in health education is more likely

to result in improved participant self-efficacy.

Discussion

The purpose of undertaking this systematic review was to examine the effect of the

teach-back method as part of an educational program or intervention for people with

chronic diseases. Due to the variation in study design and differing outcomes, a

narrative analysis was undertaken. The systematic review included 10 studies. The

distribution and quantity of these studies suggests that the teach-back method has not

been investigated widely or in a range of populations with chronic diseases. There

was also variation among the 10 selected studies in respect to educational

components, duration, follow-up period, educators, and measured outcomes. The

difference between the interventions reflects the varied ways health education using

the teach-back method is delivered. The control groups also differed, as some studies

involved standard care, and/or either verbal instructions or written materials. Self-

reported outcomes were measured using a range of validated or self-developed

instruments; however, the use of different instruments, especially those developed

for a particular study, negatively impacts the validity of outcomes measured.

Overall, the teach-back method showed positive effects, although this was not always

statistically significant. Studies in this systematic review revealed significantly

improved outcomes in disease-specific knowledge, adherence, self-efficacy, and

inhaler technique competence as the results of the teach-back method of education. A


positive but inconsistent improvement was also seen in self-care, hospital

readmission, and hospitalisation. There was a lack of strong evidence regarding the

effects of the teach-back method on improving HRQoL or retention of knowledge.

The teach-back method was mostly used to reinforce delivered information,

particularly for disadvantaged people, older adults, and those with low levels of

health literacy.

Disease-specific knowledge increased significantly in four studies. People with low

health literacy generally achieved greater disease-specific knowledge gains than

those with high health literacy (Kim, Love, Quistberg, & Shea, 2004; Rothman et al.,

2004). In another systematic review, educational programs for people with diabetes

improved knowledge about this disease (Ghisi, Abdallah, Grace, Thomas, & Oh,

2014; Norris, Engelgau, & Narayan, 2001). Although knowledge improves across

participants who receive education with teach-back method, knowledge retention has

also been observed to decrease over time (White et al., 2013). Therefore, ways to

maintain knowledge need to be included in education programs.

All selected studies in this systematic review consisted of at least one self-

management component, which accounted for positive change in enhancing self-care

activities. Simple specific self-management tasks (e.g., daily weighing, inhaler use

technique) were improved significantly when teach-back was included in the

education program. Existing studies show that providing individuals with self-care

tools (weighing scale, inhaler, measuring cup) is associated with achieving desired

behavioural changes (Bosnic-Anticevich et al., 2010; DeWalt et al., 2006; Press et

al., 2012; Rydman et al., 1999) and when combined with teach-back, adherence with

self-management behaviours could be further improved.


Only one study explored HRQoL (in relation to heart failure) and the outcome was

not improved significantly. This finding could be due to study participants having

high baseline HRQoL levels. In addition, HRQoL is a multi-dimensional subjective

concept and the selected study in this review might be not comprehensive enough to

have a significant change. Another systematic review of self-management programs

for people with heart failure did find that HRQoL improved (Ditewig et al., 2010).

This indicates the possibility that integrating the teach-back method in self-

management programs could improve the HRQoL in individuals with chronic

disease.

Selected studies revealed a hypothesised but not significant reduction in readmission

and hospitalisation among intervention participants. White et al.’s (2013) study

specifically found that people who were able to correctly answer teach-back

questions had no difference in hospital readmissions compared to those could not

answer correctly. As the teach-back method was shown to reduce hospital

readmission in previous literature (Education and follow-up cut heart failure

readmissions, 2011; Bradke et al, 2011), the lack of consistent and strong evidence in

this review suggests a need for further research on the teach-back method. As

readmission is closely associated with exacerbating disease symptoms, future

intervention needs to include early recognition of worsening symptoms when

educating patients about self-care.

This systematic review has several limitations. Despite a comprehensive search

across electronic databases, eligible studies might have been missed if the teach-back

method was not described in the studies. In addition, this review included only

studies published in English, thus, additional studies written in other languages may

have been missed. This fact might result in over or underestimation of the effect of


programs using the teach-back method. Another limitation of this review was that the

majority of studies in this review had small sample sizes, and in addition, there was

heterogeneity in the research designs and the way outcomes were measured.

Therefore, it was not possible to pool studies, so the effect estimate of the teach-back

method could not be evaluated.

Conclusion

This systematic review summarises current studies using the teach-back method to

deliver health education to people with chronic diseases. The teach-back method was

shown to benefit various health outcomes, including disease-specific knowledge,

adherence, disease-specific self-efficacy, and inhaler technique competence. There

was a positive trend towards improved self-care, reduction of hospital readmission,

and hospitalisation. There was a lack of evidence regarding the effect of the teach-

back method on improving HRQoL or retention of knowledge.

Implications for practice

Evidence from the systematic review supports the use of the teach-back method in

educating people with chronic disease to maximise their disease understanding and

promote knowledge, adherence, self-efficacy, and self-care skills. The following are

specific recommendations arising from the review (see Appendix 6 for JBI Grades of

Recommendation):

Integrate the teach-back method into education for patients and prioritise

disadvantaged people, such as those with chronic diseases, low literacy,

cognitive impairment, and older adults (Grade A).

Involve all health care professionals in using the teach-back method to

maximise patients’ understanding of the disease state, treatment, care, and

prevention of complications (Grade A).


Use the teach-back method in follow-up and reminding patients to

maintain the obtained knowledge, adherence, and self-efficacy to self-care

(Grade A).

Implications for research

Further studies with sufficient sample sizes and rigorous implementation are

necessary to explore the effect of the teach-back method on self-care, reduction of

readmission rate, improved health-related quality of life, and knowledge retention. It

is possible that more rigorous studies with longer follow-up periods may obtain

results different from those included in this review.

2.6 IDENTIFICATION OF GAP IN RESEARCH

The systematic review retrieved 10 articles that examined the effects of teach-back

with an educational program for people with chronic diseases. Overall, the teach-

back method showed positive health care outcomes, although the improvement was

not always significant. Studies in this systematic review revealed the improved

outcomes on disease-specific knowledge, adherence, and self-efficacy to self-care

and inhaler technique competence. There was a positive but inconsistent trend also

seen on improved self-care or reducing hospital readmission rates in chronic care.

There was a lack of strong evidence on the effects on health-related quality of life or

improved disease knowledge retention.

The systematic review highlighted that the teach-back method has been employed as

a component of an educational program and a method to deliver self-management.

All included studies had small sample sizes and varied in interventions and measured

outcomes. This indicated the necessity for more large trials to confirm the effects of

such programs. Of interest to this study, the outcomes of educational programs using

teach-back in people with heart failure remained limited. In addition, self-


management programs for Vietnamese people remained unknown. There is a gap

regarding the use of the teach-back method to teach self-care to people with heart

failure in Vietnam.

2.7 CHAPTER SUMMARY

This literature review chapter has provided an overview of the risk factors, impact of

heart failure, the delivery of self-management programs in heart failure, and a

systematic review of health education programs using the teach-back method in

chronic diseases. The use of the teach-back method in educating patients was seen to

achieve improved health care outcomes in terms of disease knowledge, self-efficacy,

and adherence to medication and dietary regimens. There was lack of strong

evidence regarding improved chronic self-care, reduced hospital readmissions, and

improved health-related quality of life among people with chronic disease. The

effects of self-management programs for Vietnamese HF people remained unknown;

therefore, there was a need to implement such a program in Vietnam. The next

chapter explains the theoretical frameworks that were used to inform this PhD study.

Chapter 3: Theoretical Framework 51

Chapter 3: Theoretical Framework

3.1 INTRODUCTION

This chapter presents the theoretical frameworks that underpinned this study. The

Chronic Care Model (CCM) provides a model for designing and organising chronic

care on the basis of a close linkage between six core elements (Coleman, Austin,

Brach, & Wagner, 2009). The model assumes that improvement in care requires the

involvement of patients, families, health care providers, and health care systems. The

ultimate goals of the model are appropriately prepared health care staff and informed,

activated patients who can effectively self-manage their chronic disease. The

principles of how adults learn (Adult Learning Theory) also informed this study by

assisting in the development of an education workshop for cardiac nurses. The

adoption of these two theories in the study provided the framework to inform the

subsequent intervention to be conducted.

3.2 CHRONIC CARE MODEL

3.2.1 The description of CCM

The Chronic Care Model was developed in response to the increasing burden of

chronic disease in populations and to provide approaches to chronic care and

management (Edward Wagner, 1998). The model proposes organising health care

delivery of people with chronic disease in six elements: health system, clinical

information, decision support, delivery system, self-management support,

community resources, and policies. While the first four elements address practice

efforts, the two last components are patient-focused. Together, the six elements

emphasise the need for multiple actions to enable change, and each element in the

model guides specific changes to be made to improve health care. Chronic care

52 Chapter 3: Theoretical Framework

intervention or practice improvement can be based solely on one or more of these

elements or on the entire CCM model (see Figure 3.1).

Figure 3.1 Chronic Care Model

Note. The Chronic Care Model (Wagner, 1998)

The two major components in the CCM are community resources, and policies and

health systems. The model advocates the development of linkages between services

in health care and community settings, which is essential to the delivery of holistic

care. The four other minor elements are designed below the two major elements,

including self-management support, delivery system design, decision support, and

clinical information systems. The self-management support element is a sub-

component located between the community and health systems elements, indicating

the essential contribution of both community and health care settings in supporting

efficient and effective patient self-care activities. The other three micro elements are

organised under the health care system element. The model describes how the six


elements work together to create a prepared proactive health care team, activated

patients, and their productive interaction in caring for patients themselves.

The first macro element in the model is community resources and policies. The

CCM emphasises the significance of community resources and policies in supporting

the provision of care for people in their residence. This component encourages the

partnership between health care settings and communities from which those with

chronic disease come, in order to collaboratively provide the required services.

Patients who return from acute care settings, such as hospitals, have the opportunity

to access appropriate services and resources in community facilities. People can

attend group activities with others that also have chronic disease, meet with

community health care providers, and ask for support in managing self-care.

Community-based care helps to reduce the number of hospital admissions and the

length of hospitalisation (Grealish, 2013). Moreover, patients are treated holistically

in the environment in which they live (Health Reform Implementation Taskforce,

2007). They are able to access healthy lifestyles and environment, such as free access

to public physical active regions, provision of healthy foods, and the banning or

restriction of smoking, which can be achieved by changing community policies.

Quality of care cannot be holistically improved if community contribution is not

involved in the health care reforms.

The health system is an integral element to improving the quality and provision of

chronic care services. The structure, targets, and values of a health care organisation,

as well as the relationship that it has established with people, community settings,

and other partners are the basis of the other elements in the model (Bodenheimer,

Wagner, & Grumbach, 2002). The health system needs to be designed to facilitate

the health professionals’ ability to access adequate support and resources to approach


safe and high quality delivery of care (Wagner et al., 2001). Among that, support

from health care leaders was seen to stimulate organisational changes (Piatt et al.,

2006; Siminerio et al., 2006).

Self-management support is a sub-component located between both community

and health system elements. It emphasises a mutual collaboration in the settings from

which patients receive health care services and the communities where they are

living in order to provide continuing support and follow-up. In practice, people can

be educated to adhere to their medication, diet, and lifestyle modifications to live

well with their conditions. The provision of written self-management instructions and

guides on using self-measurement tools like glucose testers, weighing scales, and

blood pressure cuffs are an essential part of self-management education. Such

education generally improves psychosocial and clinical outcomes for patients (Piatt

et al., 2006; Siminerio, Piatt, & Zgibor, 2005; Siminerio et al., 2006). In addition,

regular review care plans between patients and carers are integral to adjusting

expected goals and providing feedback on self-care and monitoring activities

(Wagner et al., 2001). For instance, follow-up telephone calls allow health care

providers to follow-up patients, gain feedback, and also provide repeated education

to people after hospital discharge. In this model, nurses are in a convenient position

to provide such educational support. Social groups also provide psychosocial support

to encourage people’s central roles in managing their heath and health care

(Bodenheimer et al., 2002).

Another essential element of the model is a clinical information system.

Computerised database systems such as disease registries and electronic medical

records enable the health care team to access timely clinical data of each patient. It

also facilitates sharing clinical information between team care members and patients


to adjust treatment medication and set goals in care plans (Wagner et al., 2001). The

information system could provide a detailed report for each individual about their

disease state, laboratory examination, medical procedure, health insurance, and cost

of care. The clinical information system also serves to monitor and assess the

performance of the practice team and care system.

Decision support involves facilitation given to health care providers to assist care

decision making and daily clinical practice. Treatment decisions are based on

evidence from clinical research. The provision of evidence-based guidelines, practice

protocols, and telemedicine meetings are therefore important parts of decision

support. Sharing of guidelines with patients is encouraged to improve their

understanding of their chronic disease and to involve their participation in making

care decisions. Furthermore, health care providers should be provided with specific

continuing training to keep them updated with current evidence-based practice and

the latest educational methods to support patients to self-manage. The participation

of other health professionals in team care, for example, dieticians, community nurses,

or care managers is recommended to deliver a holistic and effective care approach.

Another component in the model is the delivery system design. The delivery

restructure is to ensure that patients receive accurate care from well informed health

care professionals. Each team member’s role is defined and clear tasks are arranged.

The delivery of care also requires the involvement of multi health care professionals

to provide care plans for complex patients. Regular follow-up, as well as planned

visits, are an important feature of the care delivery redesign.

The goal of the CCM is a productive interaction between the health care team, who

are appropriately prepared, and informed patients who are activated to engage in self-

management. A prepared team will have to obtain sufficient clinical information


regarding patients, prepare equipment, and have the time required to deliver self-

management support and communicate the care plan. Prepared teams need to be up

to date regarding the latest research driven practice and cooperate with patients to

individualise their care plan. The care team also requires assessment tools to monitor

health care outcomes, as well as patient self-care skills. The provision of guidelines,

appropriate training, and introduction to educational methods are an effective

strategy to support care decisions. An informed patient is a person who is given the

appropriate information on the disease process, treatment, care plan, and the required

skills to self-monitor their symptoms and signs. An activated patient will realise his

or her role as the daily self-manager. Family and caregivers are engaged in the

patient’s self-management and the provider plays the role of the guide in the process.

Health care providers will communicate closely with patients to work out the goals,

care plan, and specific needs before providing them with problem-solving and self-

management skills. The interactions between health professionals and patients need

to be productive. This means that patients are given enough time, information, skills,

motivation, and confidence to make their own care decisions. In addition, with the

preparation of a professional team and activated patients, protocol use, reorganisation

of practice systems, and provider roles, improved patient education, increased access

to expertise, and greater availability of clinical information are essential to improve

health care outcomes.

3.2.2 Evidence for the Chronic Care Model

A review study on the implementation of the CCM was conducted in 2009, a decade

after the model was introduced (Coleman et al., 2009). Eighty-two CCM-based

studies conducted between 2000 and 2008 were included in this review. Fifty-one

organisations have implemented approximately 48 health care changes on the quality


and delivery of care under the orientation of the six CCM elements. Patients in the

intervention practices received improved care. Of interest to this study, the review

found that people with HF in the intervention organisations gained better knowledge,

followed lipid-lowering advice, and monitored angiotensin-converting enzymes more

often, visited less emergency care, and had 35% fewer days in hospitals (Asch et al.,

2005). Coleman’s review also confirmed health care reform involved several CCM

elements, but when more CCM elements were included, there was an overall better

quality of care for patients with various chronic diseases.

Literature produced after the year 2009 also supported the worldwide adoption of the

CCM in organising care for a variety of chronic diseases. Health reform on the basis

of CCM has improved the delivery of care for diabetes (Dancer & Courtney, 2010;

A. Lee et al., 2011; Sunaert et al., 2010; Wong et al., 2013), COPD (Fromer, 2011),

asthma (Moullec, Gour-Provencal, Bacon, Campbell, & Lavoie, 2012), heart failure

(Drewes et al., 2012), and older people with more than one chronic disease (Coburn,

Marcantonio, Lazansky, Keller, & Davis, 2012). Various improved outcomes were

seen, such as increased adherence (Moullec et al., 2012), improvement of self-

efficacy and lifestyle behaviour (Lee et al., 2011), and reduced mortality rates

(Coburn et al., 2012). The CCM adaptation has been implemented in high-income

countries (Sunaert et al., 2010), low-to-middle income countries (Pilleron et al.,

2014), and even for disadvantaged populations (Khan, Evans, & Shah, 2010). The

use of specially trained nurses as part of the CCM in 30 primary health care practices

has demonstrated a significant decrease in systolic BP (-3.63 mmHg; P = 0.050),

diastolic BP (-4.01 mmHg; P < 0.001), and LDL cholesterol (-0.21mg/dL; P = 0.033)

in the intervention group compared with control group patients (n= 326 type 2

diabetics) (Frei et al., 2014). Another study using registries (clinical information


system) and protocols (decision support) for better LDL control in people with

diabetes found a significant proportion of participants achieving LDL targets

(Halladay et al., 2014). In conclusion, the CCM has guided numerous studies

worldwide, and has demonstrated that chronic disease health care reforms relied on

some or most of the model’s elements.

3.2.3 Strengths and limitations of the Chronic Care Model

The CCM has shown its strengths in health care delivery for people with various

chronic diseases. The model has proposed systematic changes in all aspects of

delivery of care from community, health care systems, practice, and patient levels.

Furthermore, the important role of people in caring for themselves is a feature of this

model. Individuals should be motivated and actively participate in monitoring and

self-managing their condition. This element is a key goal in self-management

educational programs. In addition, the interaction between health care professionals

and patients is also goal of this model. A productive and mutual interaction is

integral to contributing to the increase in patient’s health-related understanding and

adherence of their chronic diseases, as well as their satisfaction with their health care

professionals. There have been numerous studies that involved interventions using

four to six elements of the model, and these have shown better health outcomes

(Coleman et al., 2009). This evidence also encourages local practices, with less

affordability of resources and expenses, to reform their organisation of chronic

disease care.

In contrast, difficulties have arisen in the implementation of the CCM in practice.

The model is considered to be a framework for participating organisations to develop

specific changes. Consequently, health care redesign for each particular CCM

element varies from organisation to organisation, and from country to country. The


practice improvements are therefore unlikely to be comparable across studies.

Moreover, the difference in the degree of health care reforms depends on the context

of the organisation, such as a leader’s advocacy for changes, and availability of

human and equipment resources. For example, the establishment of an effective

clinical information system requires qualified technical staff, computer systems, and

connecting networks. In settings with scarce resources it is much harder to make

those changes. In addition, the CCM changes are not immediately replicable, as

limited evidence is available about the stability of practice changes. Despite the

changes in CCM elements that generally improve the quality of care of various

chronic diseases, the extended care for people with comorbid chronic disease is still

unclear.

The advantages of adopting the CCM in this study outweigh the difficulties that

could occur. This study’s intervention does not require large efforts in making

changes to the entire six macro-elements of the model. The study focuses on decision

support, self-management support, and the goals of involving prepared nurses and

activating informed patients. The short six-hour training session and provision of HF

knowledge for nurses is expected to be accessible in Vietnam, where resources are

limited. A one-on-one educational session using the teach-back method

individualised to suit people with low education levels and elderly persons is

feasible. In addition, the intervention will promote the interaction between patients

and health professionals to develop more patient-centred care plans. Expected

knowledge improvements of both health care professionals and people with HF are

important factors related to improving health outcomes.


3.3 MALCOLM KNOWLES’ ADULT LEARNING THEORY

This study aims to improve the self-management of people with HF by having

prepared nurses and activated patients. Nurses will be trained to deliver health

education to people with HF. Teach-back is one method endorsed from the literature

to facilitate the quality of communication between patients and health educators. The

repeated instructions and asking questions that are the core principles of the teach-

back method are expected to provide information more effectively to patients and

activate them in their roles. Knowles’ Adult Learning Theory will guide the design,

development, and implementation of the training workshop for nurses, as well as the

success of patients’ educational sessions.

3.3.1 Adult learning assumptions

The differences in the way adults and children learn has been discussed for many

decades. The term “andragogy” was introduced in the early 1980s to explain the art

and science of helping adults to learn, while “pedagogy” refers to the art and science

of teaching children. Pedagogy is a teacher-centred approach, where teachers take

responsibilities in the decisions of what and how to learn. Andragogy is learner-

centred, where adults are actively involved and self-directed in their learning

activities. Given the fact that pedagogical teaching is increasingly inappropriate

when children grow up, Knowles introduced andragogy in 1980 as an emerging

strategy that facilitates the development and implementation of learning activities for

adults. Knowles’ Adult Learning Theory includes six assumptions regarding how

adults learn (Knowles, Holton Iii, & Swanson, 2012).

The first assumption is the need to know. Knowles (1980) assumed that adults

want to know the reason why they need to learn something before they engage to

learn it. When adults desire to learn something using their own self-motivation, they


will put more efforts into gaining the benefits from learning (Tough, 1979). As a

result, the first role for the facilitator of learning is to help adult learners become

aware of their need to know by explaining the value of learning to the learner’s

situation (Knowles et al., 2012).

Self-concept is the second assumption. When a person matures, adults have a self-

concept of being responsible for their decisions. Approximately 70% of adult

learning is self-directed (Cross, 1981). This means that an adult will move from

being dependent on the teacher for learning to become increasingly independent and

self-directed. Learners make decisions about content, methods, resources, and the

evaluation of their learning (Knowles et al., 2012). Options for exploring and

searching learning content will therefore be more attractive (Craig, 1996). The

advantage of self-directed learning is that it can occur in the learner’s daily life and

depends on their learning preferences. Self-directed learning can, however, be

difficult for adults with low literacy levels or those with verbal and vision

impairment, and not all adult learners prefer this style of learning.

The third assumption is the role of experience. The theory assumes that an adult

participates in an educational activity drawing on the experiences they have gained

during their lifetime. Adult educational forms, therefore, should encourage the use of

the learner’s experience to promote their motivation to learn. Group discussion and

case studies are examples of places where sharing experience is maximised to inform

learning. Prior experience, however, might prevent an adult from taking on new ideas

and changing their thinking (Knowles et al., 2012).

The fourth assumption is the readiness to learn. Adults want to learn something

that is beneficial and useful to their real-life situation. They will be ready to learn

things relevant to their job or life context. This is a naturally developed readiness


when adults reach this social biological developmental stage, or when they take on

new responsibilities in the workplace. The readiness can also be encouraged by

several techniques, such as role modelling, professional counselling and interactions

(Knowles et al., 2012).

Orientation to learning is the fifth assumption. Adults are motivated to learn

something that will help them solve their tasks or cope with real problems. They will

learn best when the subject of learning is of immediate use. Children or young people

have a subject-centred orientation to learning where they focus on learning content

needed to pass an exam or similar predetermined benchmark. By contrast, adults

develop a task-centred orientation to learning. Adults will learn content with the

intention of knowing how to use it and apply it within their life (Knowles et al.,

2012).

The final assumption is motivation. Adults are influenced by both external

motivations, such as job promotion and higher salaries; and more importantly

intrinsic motivation, such as the need for professional advancement and self-esteem.

Adults may not be motivated to learn unless they have the need to learn (Knowles et

al., 2012). Learning activities should acknowledge a learner’s likely motivation and

demonstrate to each learner where he or she would benefit in their work or personal

life (Craig, 1996).

3.3.2 Adult Learning Theory based studies in continuing training for nurses

and people with chronic diseases

The principles of Knowles’s Adult Learning Theory have been embedded in a range

of training for nurses internationally. For instance, a six-hour training workshop was

organised for 99 intensive care unit (ICU) nurses in five acute care hospitals to

promote communication skills between nurses interacting with ICU physicians and


patients (Krimshtein et al., 2011). A learner-centred approach was used in the

training sessions that included role-play exercises in the communication challenge

scenarios and encouraged nurses to discuss the difficulties that could be encountered

and to provide feedback. Nurses were asked to set their own learning goals in the

training. A variety of strategies were used to build an open and respectful

environment, as well as to create chances for nurses to seek help from others

(Krimshtein et al., 2011). This study promoted goal-setting and problem–solving

skills. Another study in which role play was a major component was conducted by

Laird-Fick et al. (2011) in which both nurses and patients were involved to create a

patient-centred care (PCC) model. The training to develop PCC skills was conducted

by trained nurse leaders. Face-to-face meetings with nurse trainees were employed to

promote the mastery of the patient-centred model. Lecture format, role–play

scenarios, and direct observation of nurse-patient contact were used as teaching

strategies within an intervention. Individual emotions and concerns in the nurse’s

professional and personal lives were a focus in the skills training (Laird-Fick et al.,

2011). In a more recent study, a group reflection format was used to provide nurses

with knowledge and confidence in the provision of support for patients with cancer

(Henoch, Danielson, Strang, Browall, & Melin-Johansson, 2013). Group reflection

created a chance for nurses to apply theoretical knowledge to their current daily care

in meeting with severely ill or final stage patients with cancer and their families

(Henoch et al., 2013). The integration of active learning in this study encouraged

nurses to achieve deeper awareness and understanding.

Educational sessions for people with chronic diseases are also designed to suit adult

learners. A variety of teaching strategies are used to meet the needs of individualised

care for patients and their families. Verbal instructions and return demonstrations are


often employed to teach people with chronic obstructive pulmonary disease (COPD)

to use inhalers (Luk et al., 2006; Press et al., 2012). Discussion with peers in an

educational intervention for individuals with chronic heart failure focused on

checking the intake of sodium volume, monitoring medicine use, and people

weighing themselves (Otsu & Moriyama, 2011). In Boyde et al.’s study (2012), a

DVD was used to illustrate role-modelling self-care strategies through scenes

including self-care, medicines, daily weighing, rest, and exercise for older people

with HF. In addition, health education maybe adjusted to be culturally specific

(Gilmer, Philis-Tsimikas, & Walker, 2005) or suit people with low literacy (Baker et

al., 2011; DeWalt et al., 2006; Kiser et al., 2012). These modifications are a feature

aimed at the needs of learners.

In Vietnam, continuing training programs for nurses are beginning to adopt adult-

learning strategies. Group discussions and role play are being introduced and

integrated with formal lectures. These training programs are designed to be more

learner-centred and encourage nurses to take responsibility for their learning.

Moreover, e-learning programs and the use of teleconferences are beginning to be

deployed in major hospitals to facilitate the introduction of other education forms.

However, nurse education is still more experience-based than evidence-based. In

addition, there is limited access to electronic databases (e.g., Medline, CINAHL,

ProQuest) in Vietnam, which is a barrier for self-directed learning and nurses

keeping up to date with international knowledge and practice. The provision of

written training materials and lecturing remain the most common teaching strategy

used for nurses in Vietnam.


3.3.3 Chronic disease health care in Vietnam

A search of Vietnamese language journals and a manual search for studies in chronic

disease in Vietnam are limited due to the availability of databases. While the

prevalence of chronic diseases is known to be increasing in Vietnam, chronic health

care is still underestimated from the macro-level (governmental) through to local

hospitals due to the overwhelming burden of acute presentations to hospitals and the

lack of widely used primary care (e.g., general practitioner service). In addition,

medical practitioners are viewed as the traditional providers of education to patients,

even though their education of patients is not routine. On the other hand, patients are

dependent on medical practitioners to diagnose and provide treatment. It is generally

seen that the low quality of health care services and shortages of qualified staff in

regional hospitals commonly result in the overload of severe patients in central

hospitals. In addition, the daily heavy workload for nurses leads them to primarily

focus on tasks (e.g., administering medications) and education of patients is not

routine practice. Therefore, patients and their family members have to be their own

key care providers, whereas no formal educational support is conducted to assist

patients to self-manage their disease conditions. Hospital discharge planning is

simply focused on reminders for future hospital visits and medication use. Self-

management education is still novel in the Vietnamese context and the term “self-

management” is not well known or understood by health care professionals.

Responses from four Directors of Nursing at the cardiac hospital sites for this study

indicated that no educational program was available for HF patients. To date, studies

on systematic CCM-based health reform remains unknown in Vietnam. Therefore, it

is particularly necessary to discover how the CCM in organising care in Vietnamese

health care settings supports self-management for people with HF.


3.3.4 Fit of two theories in this current study

In this study, the intervention was developed to achieve the final goals of the CCM

of having prepared staff and informed, activated patients. Increasing nurses’

knowledge and skill in educating and supporting patients is acknowledged as one of

the interventions contributing to the greatest improvements in health outcomes for

various chronic diseases (Coleman et al., 2009). This study aims to enhance cardiac

nurses’ knowledge so that they have the capability to provide self-management

education to people with HF. In addition, adult learning principles have been adopted

to guide educational strategies for the training of nurses (to develop prepared staff)

and teaching patients (informed activated patients) about self-management of heart

failure.

Decision support. Cardiac nurses were offered a training workshop to provide them

with a comprehensive overview of HF self-management. The educational workshop

was designed to introduce cardiac nurses to the teach-back method as a tool to

facilitate patients’ comprehension and access quality health education. The teach-

back method is a mutual communication strategy in which patients are encouraged to

give feedback on what they are unsure of, therefore enabling providers to find the

gap in patients’ understanding. This method also satisfies the needs of patients to

have adequate time for communication with health care professionals (Jager &

Wynia, 2012). In addition, nurses were provided with a heart failure self-

management booklet as their own learning material, as well as an education booklet

given to patients.

Self-management support. The cardiac nurses who received training then delivered

the teaching session to hospitalised patients with HF. Nurses shared information

written in the booklet with patients and facilitated their understanding of symptoms,


causes, and treatment. Advice on dietary regimens, daily weighing, and warning sign

recognition were given to assist patients to manage and monitor their conditions.

Patients also received a diary to complete with their measured BNP, blood pressure,

weight, etc. Their roles were explained and each person was encouraged to take

responsibility for their care. After the intervention, the desired patient outcomes were

improved knowledge and self-management skills to actively manage their heart

failure. The CCM-based intervention of this study is presented in Figure 3.2 below.

Figure 3.2 Fit of two theories to the intervention

Note. Diagram adapted from the Chronic Care Model (Wagner, 1998)

Adult learning principles were used to inform the design of the content and delivery

of the educational workshop for the cardiac nurses (i.e., intervention). It is

acknowledged that adults learn better by integrating their personal experience, thus,


role playing and group discussion were the main features of the training workshop.

Nurses were asked to discuss prepared scenarios, as well as apply the teach-back

method in their professional and personal lives. An observational checklist was

provided as a self-reflection tool and nurses were given the opportunity to receive

peer feedback. The training workshop was one day (six hours) to reduce time away

from employment. In Phase 3, the trained nurses met with patients in the intervention

group to conduct a face-to-face educational session aimed at self-management

messages. When patients understand the positive impact of adhering to a self-

management they are more likely to be motivated to participate. Adjustment of the

educational session was also considered in accordance with individual needs and

personal preference when possible.

3.4 CHAPTER SUMMARY

The CCM has been increasingly adopted to develop health care services for people

with chronic diseases. The model has provided a skeleton within which the health

care reforms are designed and delivered in a systematic manner. Current evidence

suggests that the intervention on the basis of CCM elements has shown positive

impacts in a variety of chronic diseases. In this study, the CCM was selected to guide

the development of a self-management educational program to provide decision

support for nurses and self-management support for HF individuals. The adult

learning principles were considered to assist the design and implementation of

training activities of nurses and educational sessions for people to achieve optimal

teaching and learning outcomes. The next chapter describes the research design and

methodologies used in this study.

Chapter 4: Methods 69

Chapter 4: Methods

4.1 INTRODUCTION

The use of the teach-back method to assist the delivery of self-management

education was explored in the systematic review in Chapter 2. To investigate how the

teach-back method can be used in nursing practice in Vietnam and whether self-

management education can improve patients’ health care, this study was divided into

three phases. Phase One was a pilot study to examine the feasibility of training in

heart failure (HF) self-management and the teach-back method to cardiac nurses in

Vietnam. Phase Two, which was performed simultaneously with Phase One,

translated and validated the Self-care for Heart Failure Index (SCHFI) version 6.2

into the Vietnamese language. Phase Three was a cluster randomised controlled trial

(cRCT) to assess the effectiveness of a self-management program for Vietnamese

people with HF. The Vietnamese version of the SCHFI instrument was used to

measure the self-care behaviours of HF people in Phase Three. This chapter provides

details regarding the research design in each phase, including participants, sample

size, instruments, data collection, and analytical plans. The ethical issues associated

with the three study phases are also presented. Figure 4.1 below illustrates the entire

study plan.

70 Chapter 4: Methods

Figure 4.1 Study phases

Note. SCHFI: Self-care for Heart Failure Index, HF: heart failure, RCT: randomised control trial

4.2 OBJECTIVES

The primary objectives of this PhD project were to:

1. Examine the feasibility and acceptability of a pilot training workshop on

HF self-management and the use of the teach-back method to teach self-

management in heart failure for cardiac nurses.

2. Translate and validate the Self-care for Heart Failure Index version 6.2

into Vietnamese.


back method on HF knowledge for people with heart failure who received

the program.



back method on HF self-care behaviours for people with heart failure who



back method on hospital readmissions for people with heart failure who


4.3 RESEARCH QUESTIONS

1. How well did the nurse participants evaluate the training workshops on HF

self-management and the teach-back method?

2. What were the psychometric properties of the Vietnamese version of the

Self-care for Heart Failure Index version 6.2?


knowledge compared to those who received standard care?


self-care compared to those who received standard care?

5. Was the self-management education program effective in reducing

hospitalisations compared to those who received standard care?

4.4 RESEARCH HYPOTHESES (H1)


greater heart failure knowledge than those who receive standard care.


higher heart failure self-care scores than those who receive standard care.



a lower number of hospital readmissions than those who receive standard

care.

4.5 STUDY DESIGN

In this section the research design for each study phase (one-three) will be presented,

including details on participants, settings, instruments, outcomes, data collection, and

data analytical plan.

4.5.1 Phase 1: Training HF self-management and teach-back method to

cardiac nurses: a pilot study using pre and post test design

The teach-back method has been used extensively in clinical practice, particularly to

deliver self-management education to patients with a range of chronic diseases.

However, it is not known whether this method is suitable for use by cardiac nurses in

Vietnam. Phase One of this PhD study, therefore, sought to examine the feasibility

and acceptability of using the teach-back method as a teaching tool to deliver the

contents of heart failure self-management. It involved a short training workshop

using pre/post testing of HF knowledge and an evaluation of the workshop.

Participants

Nurses from four hospitals in Hanoi, Vietnam were invited to participate in the study.

The hospitals were Vietnam National Heart Institute at Bach Mai Hospital, National

Hospital E, Huu nghi Viet Xo Hospital, and Hanoi Hospital of Cardiology; each had

a large number of cardiac nurses. Eligible nurses were those working in cardiac

wards, who were interested in health education for patients, and volunteered to

participate. No limitation on qualifications or working experience was required.


Workshop components

The training workshop was delivered to nurses over one day, comprising six hours of

education and practical training (see Appendix 7 for the program). During the

workshop, nurses heard two presentations on the teach-back method and HF self-

management, in addition to the provision of a HF booklet. Nurses then role played in

pairs or groups of three people using the teach-back method to practice delivering HF

self-management in chosen scenarios.

Teach-back method

The teach-back method was introduced as a teaching method that assists with

improving the understanding of patients. The evidence from the systematic review

about the teach-back method informed the presentation of the teach-back method

(see Appendix 8). A sample video of the teach-back method was also shown to

facilitate nurses’ understanding of how to perform the method. Three real-life

scenarios were provided for nurses to practice the teach-back method.

Heart failure self-management booklet

A HF self-management booklet was distributed to cardiac nurses in the workshop.

This booklet was translated from “Living everyday with my heart failure” with the

copyright permission of the Australian National Heart Foundation (see Appendix 9).

The booklet provided information about common HF symptoms and signs, common

causes, recognition of exacerbation of HF symptoms, salt and fluid restriction,

exercise, and medication. It also provided signs that people with HF need to

recognise and seek medical help. The booklet includes tools such as medication

reminder tables designed for people to self-monitor their daily medicine use, as well

as spaces for recording changes in weight, blood pressure, and fluid intake.


Teach-back role play

Nurses were asked to role play with another nurse using provided scenarios that

required nurses to teach patients about their symptoms, key self-management

messages, and warning signs. This session aimed to create an opportunity for nurses

to experience the teach-back method and point out any difficulties they may

encounter. The two persons changed their roles until all pairs of cardiac nurses had

played both the nurse and patient roles. A Teach-back Observation Checklist was

used as a tool to assist nurses to self-evaluate their use of teach-back (see Appendix

10). The researcher used this checklist to provide feedback to pairs of nurses who

volunteered to perform their role-play scenarios.

Instruments

Demographic questionnaire

A short demographic questionnaire, including questions about age, gender, years of

working as a cardiac nurse, highest qualifications, their confidence in educating

patients, and frequency of educating patients was used to collect information from

the nurses (see Appendix 11).

Dutch Heart Failure Knowledge Scale

The validated Vietnamese version of the Dutch Heart Failure Knowledge Scale

(DHFKS) was used to evaluate nurses’ knowledge of HF pre-and post-intervention

(Van Der Wal, Jaarsma, Moser, & Van Veldhuisen, 2005) (see Appendix 12). The

DHFKS was selected as it had been previously translated into Vietnamese. This scale

was developed to assess HF knowledge at the patient level; therefore, nurses are

expected to achieve adequate scores. If there are wrong answers, it might indicate

that nurses need more knowledge of heart failure. The DHFKS is a 15-item, self-

administered questionnaire that covers (1) general HF knowledge (4 items), (2)


knowledge of diet, fluid restriction and HF treatment (6 items), and (3) symptom and

sign recognition (5 items). For each item, one point is allocated for a correct answer

and “0” points if the answer is wrong or missing. The possible total score for

knowledge of HF ranges from 0 to 15. The higher the score nurses receive, the better

knowledge they have. This tool can be used to evaluate the effect of education and

counselling. The scale is able to differentiate between people with high and low

levels of heart failure knowledge. The original Dutch instrument has a Cronbach’s

alpha of 0.62 (Van Der Wal et al., 2005). The Dutch HF questionnaire was

previously translated into Vietnamese and pilot-tested in 30 people with HF. The

Kuder-Richardson 20 (K-P 20) reliability was 0.72 (N. H. Nguyen, Pornchai, &

Waree, 2011). The original questionnaire was aimed at patients, therefore, in three

questions (question 3, 4 and 15) the word “you” (to ask patients) was replaced with

“people with heart failure” (to ask a nurse). No answers were revised, so the validity

of adapted HF scale was deemed equivalent to that of the original Vietnamese patient

version. Permission was provided by the author of the Vietnamese version.

Evaluation form

This form was used to explore nurses’ evaluation about the feasibility of the teach-

back method, which workshop sessions were most valuable to them, and the

messages they would deliver to their colleagues (see Appendix 13). Nurses provided

written feedback about how the workshop could be developed in the future. This

feedback will be helpful in future refinement of workshop’s contents and structure.

Procedure

At the beginning of the workshop, participating nurses were asked to answer the

demographic questionnaire and the Dutch Heart Failure Knowledge Scale. The

workshop was then conducted as described above. At the end of the workshop, all


nurses answered the Dutch Heart Failure Knowledge Scale again, and were invited to

fill in an evaluation form asking for the feasibility of using the teach-back method in

their routine practice and their feedback on the contents and structure of the

workshop.

Data analysis

Demographic variables were presented in means and standard deviations for

continuous variables. Categorical variables were presented in numbers and

percentages. The knowledge scores of the nurses were calculated aggregately using

mean and standard deviation. Paired t-test was also used to compare the mean score

differences of nurses prior to and after the workshop. The nurses’ responses to the

structured questions in the evaluation form were summarised in numbers and

percentages. Responses to the open questions in this form were summarised in key

messages and themes.

4.5.2 Phase 2: Translation and validation of the Self-care for HF Index v6.2

using Brislin’s Translation Model

Phase Two involved the translation and validation of the Self-Care of Heart Failure

Index v6.2 (hereafter referred as SCHFI) into Vietnamese, which was used to

measure the outcome in Phase Three. Translation is integral where the study

instruments were previously developed in another language. Brislin’s translation

model is one common method for translating and validating research instruments to

be used in cross-cultural contexts (Cha, Kim, & Erlen, 2007; Sousa & Rojjanasrirat,

2011; Symon et al., 2013; Yu, Lee, & Woo, 2003). The method for this phase was

driven by the Sousa and Rojjanasrirat's guideline, which consisted of five steps

(Sousa & Rojjanasrirat, 2011). The translation process involved translation of the

original SCHFI v6.2 into Vietnamese and backward translation of the Vietnamese

version into English to ensure the equivalence of the target language instrument with


the original version (Maneesriwongul & Dixon, 2004). The validation included

content validity assessed by an expert panel, internal consistency by Cronbach’s

alpha, and construct validity investigated by confirmatory factor analysis.

Self-care for Heart Failure Index v6.2

Permission to translate the SCHFI was sought from the instrument’s developer (see

Appendix 14). The SCHFI is a self-reported questionnaire that consists of 22 items

(see Appendix 15 for the questionnaire). This instrument is divided into three

subscales: (i) self-care maintenance measuring symptom monitoring and treatment

adherence; (ii) the self-care management scale measuring occurrence of symptoms,

symptom evaluation, treatment implementation, and evaluation; and (iii) confidence

in the self-care process. The questionnaire was first developed in 2004 with 15 items

(five maintenance items, six management items, and four confidence items). The

Cronbach’s alpha for this instrument was 0.76, indicating an adequate reliability

(Riegel et al., 2004). The original self-care maintenance scale’s reliability was lower

than expected (α = 0.56), therefore, this instrument has been updated to a 22-item

scale; most of the revised items were in the self-care maintenance sub-scale. This

updated version has been translated into various languages and was used in previous

studies (Ávila et al., 2013; Boyde et al., 2013; Vellone, Riegel, Cocchieri et al.,

2013; Vellone et al., 2012).

Translators

Four bilingual translators conducted the translation process and were paid a small

honorarium for their time (AUD 95 for 2.5 hours of translation). Two did the forward

translation from English to Vietnamese. Both forward translators were PhD prepared

nurses with more than six years’ experience in nursing education, who demonstrated

an adequate English proficiency with a minimum achievement on the International


English Language Testing System of 6.5. Both had previously been involved in

cross-cultural studies using foreign language questionnaires. One nurse had been

invited to be a translator in several previous studies.

One doctor and another nurse undertook the back translation from Vietnamese to

English. Both translators held post-graduate university qualifications with a

minimum of seven years’ experience in health. Both had International English

Language Testing System scores of 6.5. The doctor was working in hospitals, while

the nurse was a university academic. The nurse translator has conducted a project

using forward-backward translation processes. Both backward translators were

unfamiliar with the original SCHFI instrument.

Process of translation and validation

The translation and validation process consisted of five steps. The translation process

involved three steps: Step 1) the SCHFI was translated into Vietnamese; Step 2) the

Vietnamese version was back translated into English (V.SCHFI); and Step 3) the

V.SCHFI was compared with the original SCHFI. Step 4 involved a group of 10

people who were familiar with cardiac care contexts assessing the content validity of

the V.SCHFI. Step 5 was the psychometric testing of the instrument in Vietnamese

people with heart failure. The entire translation and validation process is illustrated in

Figure 4.2.


Figure 4.2 Translation and validation process

Note. Diagram adapted from Sousa and Rojjanasrirat's guideline (2011)


Step 1: Forward translation of the SCHFI

The translation process began with the translation of the original SCHFI into

Vietnamese by two independent bilingual native Vietnamese nurses. Their

understanding of HF and health care contexts was essential to ensure linguistic

equivalence between the two languages and assure the appropriateness of language

usage. If there were differences in the two translated versions, then the researcher

and both translators discussed changes and came to an agreement to synthesise the

pre-final translated instruments.

Step 2: Backward translation of the Vietnamese SCHFI

In this step, the Vietnamese version of the SCHFI was back translated into English

by two different bilingual translators who were unfamiliar with the original English

version. This method of blinding assured that the meaning of the English version was

adequately reflected in the back-translated version (Brislin, 1970). Both of the back-

translators and the researcher discussed differences in the two back-translated

versions and came to an agreement to synthesise the pre-final English backward

translation.

Step 3: Comparison of the SCHFI and the backward translation of Vietnamese

SCHFI

The original English version and back translation of SCHFI were sent to the

supervisory team for review. The supervisors, as English native speakers, ensured

that the back translation was congruent to the original. Any problematic wording or

items were noted and returned to either forward or backward translators for their

discussion and revision. The final Vietnamese translation was deemed complete

when the supervisory team agreed that its backward translation was equivalent to the

original.


Step 4: Expert panel review of the Vietnamese SCHFI

A native monolingual expert panel of ten people was formed to assess the content

validity of the instruments (Sousa & Rojjanasrirat, 2011). Eight panel members were

health care professionals comprising two cardiac nurses, one cardiologist, one

general doctor and four general nurses, to judge four aspects of the instrument

(relevance, clarity, comprehension and appropriateness). Two lay people (a primary

school teacher and an older person), were invited to assist with meaning and

expression. Invited panellists who voluntarily agreed to participate in the study were

sent the final Vietnamese SCHFI and an assessment tool detailing guidance for their

assessment tasks (see Appendix 16). The selection criteria for health professional

experts were:

Experience in instrument translation;

Familiar with health care for people with heart failure.

A four-point Likert scale was used to rate each item of the Vietnamese SCHFI across

the four criteria: relevance, clarity, comprehension, and appropriateness of

measurement scale. Panellists were asked whether the translated items were relevant

to health care of HF (relevance). They also assessed whether items were clear to

measure patients’ major self-care behaviours in HF (clarity). If items were rated

unclear, the panel were asked to comment as to how these items could be improved.

Any item that was found to be unclear by at least 20% of panel members (two

people) would be revised and re-translated. In addition, panel members were asked to

assess whether each translated item could be understood by Vietnamese people (who

mostly have low health literacy) (comprehension). Finally, the use of a four-point

measurement scale assessed for appropriateness in evaluating the possibility of

patients’ responses (appropriateness). To improve accuracy, appropriateness, and


relevance of items, the panellist were asked to add, delete, or shift questions to

modify the instrument as most appropriate to the context of Vietnam.

The content validity indexes (CVI) were measured at the item level (i-CVI), sub-

scale level (sub-CVI/Average), and scale-level (s-CVI/Average). The i-CVI was

assessed by the proportion of panellists rating the item relevance ≥ 3. The sub-

CVIs/Averages were computed using the average proportion of panellist’s agreement

across the total number of items in that subscale. The s-CVI/Average was calculated

by average i-CVIs over 22 items in the V.SCHFI. The acceptable content validity

criteria in this study were i-CVI ≥ 0.78; sub-CVI/Average and s-CVI/Average ≥ 0.9

(Polit, Beck, & Owen, 2007; Sousa & Rojjanasrirat, 2011). Any items that did not

achieve an expected CVI of at least 0.78 were revised according to the panellist’s

comments.

Step 5: Pilot psychometric testing of the Vietnamese SCHFI

The baseline responses to the Vietnamese SCHFI from participants in Phase Three

(n = 140) were used to analyse the psychometric properties of this instrument. First,

internal consistency reliability (using Cronbach’s alpha coefficients) was calculated

separately for each subscale of the V.SCHFI as recommended by the instrument

originators (Riegel, Lee, Dickson, & Carlson, 2009). The acceptable internal

consistency for a self-reported instrument is ≥ 0.7 (Gliem & Gliem, 2003; Tavakol &

Dennick, 2011). As SCHFI was theory-based, confirmatory factor analysis (CFA)

was used to test the 3-factor structure of the V.SCHFI. Self-care management was

calculated only for those who responded ‘yes’ to either having trouble breathing or

ankle swelling in the last month, CFA was conducted with the data pool of 100

participants who had an available self-care management score. This analytical

approach was conducted to replicate the original SCHFI testing (Riegel, Lee,


Dickson, & Carlson, 2009), and to compare the Cronbach alpha of V.SCHFI to

previously published different languages versions of SCHFI. Data was analysed

using SPSS 21 and SPSS Amos 22.

As low Cronbach alpha coefficients for two subscales (self-care maintenance and

self-care management) were consistently reported in SCHFI testing studies, and no

study found a model fit of three-factor structure of SCHFI, it was hypothesised that a

dimensionality existed in each SCHFI subscale. Recently Barbaranelli et al., (2014)

demonstrated that the SCHFI is not one-dimensional, and that the (a) self-care

maintenance scale has a multidimensional four-factor structure, (b) self-care

management has a two-factor structure, and, (c) self-care confidence is one-

dimensional. So in the next step, CFA was separately conducted for each subscale of

the V.SCHFI to confirm the new structures. In both analyses, the criteria for a good

model fit of CFA were used (see Table 4.1). Insignificant p value of Chi-square

goodness-of-fit (≥ 0.05) indicated a model fit.

Table 4.1 Goodness-of-fit model indices

Index Fit model criteria

CMIN/df < 3

P value ≥ 0.05

Normal fit index (NFI) > 0.95

Comparative fit index (CFI) > 0.95

Root mean square error of approximation (RMSEA) < 0.05

PCLOSE ≥ 0.05

Note. CMIN/df: Chi square/degree of freedom, PCLOSE: p value for the null hypothesis RMSEA ≤

0.05. The Goodness-of-fit model indices (Hair, Black, Babin, & Anderson, 2014).


4.5.3 Phase 3: Cluster randomised controlled trial of a self-management

program for Vietnamese people with HF

The main study within this PhD project was a cluster randomised controlled trial

(cRCT) to compare the effects of a self-management program and usual care for

Vietnamese people with HF. The self-management program was delivered on an

individual basis to the intervention group. The control group received standard care.

Outcomes were HF knowledge, HF self-care, and the number of hospitalisations

measured over three months follow-up. The study outcomes were assessed and

interpreted at the level of individual participants.

The alternative hypotheses generated from the trial were:

People who receive the self-management program will have greater heart

failure knowledge than those who receive standard care.

People who receive the self-management program will have a higher self-

care score than those who receive standard care.

People who receive the self-management program will have lower

numbers of hospital readmissions than those who receive standard care.

Rationale for cluster randomisation

The unit of randomisation was clusters (wards) in this study, which was chosen for

practical reasons and to prevent participant contamination. If individual

randomisation was applied, the risk of contamination between participants in the two

different study groups would have been more likely to occur, because in Vietnam,

patients share hospital beds and have lengthy periods of hospitalisation. Hence,

wards were randomised and all eligible patients in each ward participated in the

study. Figure 4.3 presents the process of the trial.


Figure 4.3 Flow chart of the cRCT

Note. Adapted from CONSORT flow chart for cluster randomised trials (Campbell, Piaggio,

Elbourne, Altman, & Grp, 2012)

At 1st and 3

rd month:

Knowledge (DHFKS)

Self-care (SCHFI)

Hospital readmission

(self-reported)

At 1st and 3

rd month:

Knowledge (DHFKS)

Self-care (SCHFI)

Hospital readmission

(self-reported)

Randomised (6 wards) Enrolment

Intervention group

(70 participants, 3 wards)

Receive self-management

program

Control group

(70 participants, 3 wards)

Receive standard care + HF

booklet

Usual care Follow-up telephone

call at two weeks

Follow-up

Data collection

Assessed for eligibility

Allocation


Setting and unit of randomisation

The Vietnam National Heart Institute in the Bach Mai hospital was selected as the

study setting. Bach Mai hospital is the largest tertiary medical hospital in the north of

Vietnam. The hospital has 1,900 beds and comprises two institutes, eight centres, and

21 clinical departments to accommodate patients with surgical and medical

conditions from Hanoi and other local regions. Bach Mai hospital receives and treats

an average of 600,000 outpatients and 75,000 inpatients every year. This hospital is

also responsible for clinical placement for medical and nursing students from Hanoi

Medical University, one of the leading medical universities in Vietnam. Bach Mai

hospital also has a nursing college that offers a three-year nursing training program

to provide a nursing workforce for the hospital and other health care settings. The

Vietnam National Heart Institute became the cardiac department of Bach Mai

hospital in 1989 and is one of the largest institutes for cardiac health care, training,

and research in Vietnam. The institute comprises 303 beds divided into an Intensive

Care Unit (25 beds), operating theatre (47 beds), paediatric ward (23 beds), and six

inpatient wards (total 208 beds). The Institute admits approximately 17,000-22,000

cardiac patients annually.

The six inpatient wards range in bed numbers from 27 to 54, however, the average

bed occupancy was approximately 200% (i.e., two patients per bed). Each ward has a

separate health care team, although the routine treatment for people with HF was the

same. Patients on these wards come from areas in and surrounding Hanoi, and

include several ethnic minorities (i.e., Kinh, Mong), various socioeconomic statuses,

and literacy levels. For this reason, it was considered that patients with HF in the

Vietnam National Heart Institute were likely to represent the general HF population.

Computer randomisation software was used to allocate each inpatient ward into one


of the study arms (https://www.random.org/#lists). Eligible people in each ward

received either the intervention or control care on the basis of their ward allocation.

Figure 4.4 illustrates the ward allocation in the study setting.

2nd

floor Control

ward

Intervention

ward

Control ward Operation

theatre

Intervention

ward

1st floor Intensive

Care Unit

Intervention

ward

Paediatric

ward

Control

ward

Administration

office

Figure 4.4 Ward allocation

Note. The study setting was a building with 2 floors and 9 wards and 1 administration office. The

intervention wards are in green, the control wards are in grey. Other wards were not involved in

participant recruitment.

Participants

A list of patients with a HF diagnosis admitted into those six wards was extracted

from the hospital record every two days. Their medical records were then screened

for the eligibility.

Inclusion criteria: Eligible participants were 1) adults aged 18 to 80 years old, 2) an

in-patient with a confirmed New York Heart Association class II-IV diagnosis of

heart failure within the last three months, 3) able to communicate in Vietnamese

language and 4) able to provide consent to participate in the study.

Exclusion criteria: Patients who were 1) critically ill (receiving renal replacement

therapy, or requiring oxygen therapy), 2) waiting for surgery, 3) pregnant, or 4)

cognitively impaired.

https://www.random.org/#lists


Self-management program

The HF self-management program (intervention) was delivered to each participant at

the bedside close to the day of discharge from hospital. The intervention consisted of

a one-on-one educational session delivered by a nurse trained to use the teach-back

method in patient education. The educational session was given once, and of an hour

in duration to make the program feasible (as teaching HF self-management was

new), and was consistent with previous HF self-management interventions. Patients

were given a HF patient information booklet, weight scales and a diary for recording

symptoms. The bedside educational session taught participants about common signs

and symptoms of HF, how to manage each symptom, fluid management, salt

restrictions, medication use, exercise, recognition of worsening symptoms, and signs

to look before seeking help. The participant were asked to repeat the content they

have just been taught. If the participant could not accurately teach-back the

information to the nurse, the nurse explained again until there was sufficient

understanding. Family members of the patient were welcomed to attend the

educational session if they were available.

The HF patient information booklet was translated and adapted from “Living

everyday with my heart failure” with copyright permission from the Australian Heart

Foundation (see Appendix 9). Participants were also taught the steps to measure their

weight and record it in the diary. The diary provided space for participants to record

their existing symptoms, daily fluid intake, blood pressure, and medications being

used. A follow-up telephone call from the researcher was provided two weeks

following discharge to consolidate the educational session and to ascertain any

readmission to hospitals (see Appendix 17 for the follow-up questionnaire). When a

participant forgot a self-management message, the process of teaching-back would


occur. There were no other educational activities targeting people with HF in the

hospital during the study period. All participants then continued to receive standard

care. Questionnaires were distributed again at one and three months.

The nurse delivering the intervention received three training sessions from the

researcher regarding the intervention and how to use the teach-back method to

educate participants. During the training, the researcher role-played the delivery of

the intervention to the nurse. The researcher observed the nurse providing the

educational sessions to the first 10 participants.

Standard care

In this group, participants received the usual care provided on a routine basis in the

hospital. Usual care education is often a very brief discussion (10-15 minutes),

delivered once at discharge by a medical physician and focuses on medications. It

does not specifically target HF self-management. Nurses in Vietnam do not currently

routinely provide discharge information to patients. Each participant in the control

group also received the HF booklet identical with the intervention. The researcher

briefly explained the content of the HF booklet without using the teach-back. The

usual care group also received a telephone call at two weeks following discharge,

which was used to ascertain any readmission to hospitals and to maintain contact. No

diary or weighing scales were provided. The contact between participants in the

control group and the researcher was at enrolment and on the two occasions of data

collection.

Study instruments

Study outcomes were HF knowledge, self-care, and hospital readmission/death. A

number of self-reported instruments were used to collect the demographic

information of participants and to measure the outcomes of the study.


Demographic questionnaire (baseline only)

A demographic questionnaire was developed by the researcher to collect baseline

information including age, gender, occupation, qualification level, length of HF

diagnosis, and marital status (see Appendix 18). Other measures such as HF severity

(assessed by the New York Heart Association category), weight, height, blood

pressure, blood glucose, creatinine, beta-type natriuretic peptide were extracted from

medical records. Estimated glomerular filtration rate (eGFR) was calculated from the

serum creatinine level, age, and gender of each participant.

Charlson Comorbid Index (baseline only)

The Charlson Co-morbid Index questionnaire was used to examine the level of the

comorbidity of participants (Quan et al., 2011) (see Appendix 19 for the Charlson

Comorbid Index). The Charlson comorbidity index predicts the ten-year mortality for

a patient who may have a range of comorbid conditions, such as heart disease, AIDS,

or cancer (a total of 17 categories). Each condition is assigned a score of 1, 2, 3, or 6,

depending on the risk of dying associated with each one. Scores are summed to

provide a total score to indicate severity of comorbidities. A total score of 1-2 is

considered as low, 3-4 is moderate, and more than 4 indicates high comorbidity

(Davis et al., 2012). The researcher reviewed participants’ medical records and

determined whether a particular condition was present in order to calculate the index

for each participant.

Vietnamese version of the Dutch Heart Failure Knowledge Scale

Heart failure knowledge was measured by the Vietnamese version of the Dutch Heart

Failure Knowledge Scale (DHFKS) (Van Der Wal et al., 2005) (previously referred

to in Appendix 12). The DHFKS is a 15-item self-administered questionnaire that

covers HF symptoms recognition, diet fluid restriction, medication compliance and

https://en.wikipedia.org/wiki/Heart_disease

https://en.wikipedia.org/wiki/AIDS

https://en.wikipedia.org/wiki/Cancer


exercise. For each item, one point is allocated for a correct answer and 0 if the

answer is wrong or missing. The possible total score for knowledge of HF ranges

from 0 to 15. The higher the score participants receive the better knowledge they

have. This tool can be used to evaluate the effect of education and counselling. The

scale is able to differentiate between people with high and low levels of HF

knowledge. The DHFKS was selected because it is a short scale (requires

approximately 10-15 minutes to complete), and is easy to read and answer. The

Kuder-Richardson 20 reliability coefficient of the Vietnamese version of DHFKS

was 0.72 (N. H. Nguyen et al., 2011).

Vietnamese version of Self-care for Heart Failure Index

Heart failure self-care domains were measured by the Vietnamese version of the

Self-care for Heart Failure Index v6.2 (Riegel et al., 2009) (see Appendix 20). This

instrument consists of 22 items divided into three scales: (i) self-care maintenance

measuring symptom monitoring and treatment adherence; (ii) self-care management

scale measuring occurrence of symptoms, symptom evaluation, treatment

implementation and evaluation; and (iii) confidence in the self-care process. The

total score of this questionnaire is 100. A score of 70 and over indicates self-care

adequacy. The Cronbach’s alpha of the original questionnaire was 0.76, with a

reliability coefficient for the confidence subscale of 0.84, the management subscale

of 0.59, and the maintenance subscale (0.54) (Riegel et al., 2004). Translation and

validation of this questionnaire into Vietnamese was described in Phase Two. This

instrument was selected for use in this study because it has been widely used in

previous studies with HF people and was recognised as a reliable tool to measure

self-care in this population (Boyde et al., 2013; Davis et al., 2012). Calculation of

each SCHFI subscale score was as follows:


Self-care maintenance = (sum of section A items – 10) * 3.333

Self-care management = (sum of section B items – 4)*5

Self-care confidence = (sum of section C items – 4) * 8.333

Hospitalisation sheet

A study dataset was created to record the number of hospitalisations for each

participant at two follow-up occasions. A hospitalisation is defined as a patient stay

of at least one night in hospital for treatment. A hospital readmission is defined as

patient admission to a hospital within 30 days after being discharged from an

earlier hospital stay. As there is a lack of a hospital registry system in Vietnamese

hospitals, patients were able to be readmitted in different hospitals. The hospital

readmissions and associated causes were, therefore, collected by participants’

reports. All-cause hospitalisations were counted for all hospitalisations, including

non-cardiac reasons, such as injuries and treating other health conditions. Cardiac-

cause hospitalisations were where patients readmitted due to HF symptoms or

treatment complications, for example: fatigue, trouble breathing, oedema, and

urgency of medication changes.

Sample size calculation

The sample size for a cluster randomised controlled trial is calculated by multiplying

the required sample size for an individual randomised controlled trial by the design

effect (Campbell & Walters, 2014; Eldridge & Kerry, 2012).

The individual RCT’s sample size was calculated using the following formula:

N = 2𝑥 2 𝑥 𝑆𝐷 𝑥 𝑆𝐷

𝐷𝑥 𝐷 𝑥 (𝑧

𝛼

2+ 𝑧𝛽) 2


In the formula, D was the expected mean difference between the knowledge score of

the intervention group between baseline and end-point measurement; SD was the

standard deviation of the mean difference in the knowledge score.

Using the expected mean knowledge scores of 1.61 ± 2.2 (measured using the

DHFKS instrument) by Boyde et al. (2012); standard type I error α = 0.05 and

expected type II error β = 0.2 (or power 0.8), the sample size was

N = 2 𝑥 2 𝑥 2.2x2.2

1.61𝑥1.61 𝑥 (1.96 + 0.84) 2 = 59 people

Then using the formula for the design effect of the cluster randomised trial

DE = 1 + (m-1)ρ in which m = fixed cluster size and ρ = intra-cluster correlation

coefficient. The cluster size is the number of individuals analysed in each cluster.

Intra-cluster correlation coefficient quantifies the correlation between the outcomes

of any two individuals within the same cluster. It was estimated that 20 participants

would be recruited from each ward. The intra-cluster correlation coefficient of 0.05

was selected. This value indicates a moderate level of similarity between participants

regardless of the ward (Butler et al., 2013; Spanou et al., 2010). The drop out for the

study was estimated at 20%.

DE = 1 + (20 – 1) x 0.05 = 1.95.

The final sample size was

N = n x DE x (1 + drop-out rate)

= 59 x 1.95 x 1.2 = 139 (both groups)

= 140 (rounded for equal distribution)


A total of 140 participants (70 per group) were needed to provide 80% power and a

2-sided significance level of 0.05 to detect an improvement in HF knowledge of 1.61

point.

Implementation and data collection

All eligible patients admitted to the cardiac wards in the Vietnam National Heart

Institute from July to November 2014 were approached to participate in the study.

The recruitment process continued until the required sample size was achieved.

Participants received either the intervention or control care depending on their ward

allocation. The researcher explained the participant information sheet to all eligible

participants and informed consent was obtained prior to the administration of the

baseline questionnaires. The intervention/standard care was then delivered. The

researcher conducted follow-up phone calls with the intervention group. The

researcher collected the responses of participants to the DHFKS and the SCHFI at

baseline, and at one and three months after the intervention commenced.

Blinding

Blinding is generally not possible in this type of study (Campbell et al., 2012).

Participants were aware of the group they have been allocated to. Health care teams

in participating wards were informed about the study although they were not aware

of the research questions and measured outcomes. The research assistant nurse was

employed to deliver the intervention to participants and was not involve to the

control group or the process of data collection. The chief investigator was

responsible for conducting randomization, distributing questionnaires, and collecting

data from participants to ensure study fidelity.


Management of missing data

Attrition is a common problem in health care trials, due to death, withdrawal, or loss

to follow-up. To minimise drop-out rates, several strategies were used to keep

contact with participants. First, the researcher obtained the mobile/landline phone

numbers, the home address of each participant, and detailed contacts of their nearest

caregiver. Second, a follow-up telephone call was conducted at two weeks in order to

reinforce intervention and promote adherence. Third, at least five phone call attempts

were made, and participants who could not be contacted at times of data collection

were then recorded as lost to follow up. The reasons for any withdrawal were

recorded.

There are several data analysis approaches for dealing with missing data in health

care trials, including using complete data, available data, and imputed data. Complete

data analysis involves only cases with available data in each variable, and this

approach is likely to reduce sample size, therefore reducing statistical power.

Imputation of missing data is a process where a reasonable value is altered for one

that is missing. However, this approach is controversial because it is likely to narrow

the standard deviations of the data (Sterne et al., 2009). Analysis using available data

is an advanced statistical technique that permits available data of all participants to

be analysed, including those with missing data at some observations and that reflect

intention to treat principles (Armijo-Olivo, Warren, & Magee, 2009). In this study,

analysis using available data was used.

Data analytic plan

Each response in the questionnaires was scored before being entered into SPSS. Data

was assessed for missing values, outliers, and typing errors. Mean and standard

deviations, or medians and interquartile were used to describe continuous variables,


including age, length of stay, number of medications, clinical measurements (BP,

HbA1C, etc.) and HF knowledge and self-care scores. Numbers and percentages

were calculated to describe categorical variables, for example, gender, education

level, occupation, and marital status. Independent t-tests or Mann-Whitney U tests

were employed to examine the baseline differences in continuous demographic and

outcome variables (i.e., HF knowledge and self-care scores) in two study groups.

Chi-square or Fisher Exact tests were used to explore the baseline differences in

categorical variables between the two groups. The level of significance was set at p-

values equal to or less than 0.05.

This study used intention-to-treat principles in data collection and analysis. The

intention-to-treat analysis preserves the sample size, because if noncompliant

subjects and dropouts are excluded from the final analysis, it might significantly

reduce the sample size, leading to reduced statistical power (Gupta, 2011). This study

used linear mixed effect models to examine the effects of the intervention in

continuous outcomes. The linear mixed effect models include all available data of all

participants in the analysis, involving those with missing data at some time points,

therefore, data from all participants contributed to the final analysis (intention-to-

treat analysis) (Armijo-Olivo et al., 2009; Gadbury, Coffey, & Allison, 2003). In

addition, linear mixed models are also an advanced statistical method to account for

the random effect of clusters in cluster randomised trials (Campbell & Walters, 2014;

Eldridge & Kerry, 2012). Hospital readmission or death were counted and compared

by relative risks. Missing data in hospital readmission/death variables was replaced

with either “no event” or “at least one event”, while “event” indicated a readmission

or death.


4.6 ETHICAL CONSIDERATIONS

The study involved human participants; therefore, ethical approvals were sought

from relevant institutions. As Phase One and Two were conducted prior to Phase

Three, a separate ethics application for these phases was first submitted to Hanoi

School of Public Health Research Ethics Committee (164/2013/YTCC-HD3, see

Appendix 21) and then the Human Participant Ethics Committee in Queensland

University of Technology (QUT) (1300000704, see Appendix 22). Approval for

ethical integrities of the main trial (Phase Three) was sought from QUT Ethics

Committee (1400000374, see Appendix 23). Permission was also given from the

Director of Vietnam National Heart Institute in Hanoi for Phase Three to be

implemented in the setting (see Appendix 24).

The researcher sent a letter to each Director of Nursing of the four selected hospitals

to introduce the Phase One study and to seek their permission to present the Phase

One study to nurses. The researcher attended a nurses’ handover meeting in each

hospital to explain the purposes of the Phase One study and invited nurses to

volunteer. A participant information sheet was provided to nurses, and the researcher

answered questions regarding their participation in the study. Nurses who were

interested in the study and were willing to participate were invited. Their

participation in the workshop was deemed to be an indication of the consent to

participate in the study.

All translators involved in translating the SCHFI were approached via email with a

participant information sheet and consent form. Translators were invited to

participate, and following their agreement, signed a consent form and were sent a

guideline detailing their tasks. The translators were selected from the list of

Vietnamese Nursing Project Scholarship recipients at School of Nursing, Queensland


University of Technology. One translator came from Bach Mai hospital, Hanoi,

Vietnam.

A letter briefly introducing the cRCT was sent to the Director of Nursing and doctors

in Vietnam National Heart Institute to ask for their permission to approach and

recruit patients in cardiac wards. All eligible participants in participating wards were

met by the researcher to explain about the trial and invite their participation. A

participation information sheet provided a brief explanation of the purposes, risks,

and benefits of this study and the process of data collection. The researcher affirmed

that the participant’s decision to participate or not would not have any impact on

their treatment or their relationship to Vietnam National Heart Institute, QUT, or

Hanoi Medical University. Participants did not have to complete any questions they

felt uncomfortable answering and could withdraw their consent at any point in time.

The control wards were offered a chance to receive the intervention upon the

completion of this study. All responses were treated confidentially and no

information collected from participants could be used to identify them. All

completed questionnaires were stored in the researcher’s office cabinet. Data was

inputted in SPSS, which was saved in a computer secured by a username and

password that only the researcher was able to access.

4.7 CHAPTER SUMMARY

This chapter presented the detailed methods of this PhD study, which comprised

three separate phases. The study aimed to introduce the teach-back method and HF

self-management to both nurses (Phase One) and patients with HF (Phase Three).

Phase One explored the acceptability of using the teach-back method in the practice

of cardiac nurses. Phase Two (translation and validation of the SCHFI) was a

supplemental study to prepare a validated instrument to measure self-care for


Vietnamese people with heart failure. Brislin’s translation model was adopted during

forward and backward translation. The validation process investigated internal

consistency, content validity, and construct validity of the Vietnamese language

version of the SCHFI. The cluster randomised controlled trial (Phase Three) was

designed to examine the effectiveness of a self-management program delivered to

people with HF in Vietnam. This chapter has described in detail the sample size,

instruments, data collection, and analysis undertaken for each phase.

100 Chapter 5: Results

Chapter 5: Results

5.1 INTRODUCTION

Chapter 4 detailed the research design for the entire study. This chapter presents the

results obtained from the three phases. The results from Phase One presented the

nurses’ evaluation of a pilot training workshop introducing nurses to HF self-

management and the teach-back method as a teaching tool to deliver health

education. This phase also involved assessment of nurses’ HF knowledge prior to

and after receiving the training workshop. Phase Two translated the Self-care for

Heart Failure Index version 6.2 (SCHFI) into Vietnamese (V.SCHFI) and assessed

the content validity, internal consistency, and construct validity of the V.SCHFI in a

sample of Vietnamese people with HF. The main study was a cluster randomised

controlled trial (Phase Three) examining the effects of a HF self-management

program on HF knowledge, self-care, and hospital readmission of Vietnamese people

with HF.

5.2 RESULTS OF PHASE ONE: THE TRAINING WORKSHOP ON HF SELF-

MANAGEMENT FOR NURSES

5.2.1 Demographic characteristics

Four major hospitals with large cardiac wards in Hanoi were invited to participate in

the study (Bach Mai, Huu Nghi, National E Hospital, and Hanoi Institute of

Cardiology). Three hospitals provided permission; 21 nurses registered to attend the

workshop, however, one nurse did not attend. Subsequently there were a total of 20

nurses participating in the workshop (10 nurses from Bach Mai, five from E hospital,

and five from Huu Nghi). Eighty-five percent of participants were females. The

average age of the nurses was 34.5 years. The average years working as a nurse was

11.6 years. Half of the nurses held a graduate degree, one had achieved a post-

Chapter 5: Results 101

graduate qualification, and other nurses had completed two or three years of training

in nursing colleges. All nurses except two had never heard of the teach-back method;

however, these two nurses did not describe the teach-back method correctly. Details

of the demographic characteristics of the participants are presented in Table 5.1

below.

Table 5.1 Demographic characteristics

Characteristics N= 20 N (%)

Age (years), mean (SD) 34.5 (7.9)

Years working as nurse, mean (SD) 11.6 (8.3)

Unfamiliar with teach-back method 20 (100%)

Place of work

Bach Mai Hospital 10 (50%)

Huu Nghi Hospital 5 (25%)

National E Hospital 5 (25%)

Gender

Female 17 (85%)

Male 3 (15%)

Type of nurse

Cardiac nurses 17 (85%)

Internal medical nurses 2 (10%)

Chief nurse 1 (5%)

Highest qualifications

Masters 1 (5%)

Bachelor of nursing 11 (55%)

3-year college training 1 (5%)

2-year college training 7 (35%)

5.2.2 Pre-test and post-test results

All participants were invited to complete the Dutch Heart Failure Knowledge Scale

(DHFKS) as a pre- and post-test measure to assess their knowledge of heart failure.

One nurse missed the pre-test. All twenty nurses completed the post-test at the end of

the workshop. There were no missing responses. Each correct answer was scored as

1. Missing or incorrect responses were as scored 0. The total score was a sum of the

correct answer scores, ranging from 0 - 15. Higher scores indicated better

knowledge. A score ≥11 was deemed as adequate knowledge. The average pre-test


score was 12.7 (SD = 1.2) and post–test score was 13.8 (SD = 1.0). The test of

normality revealed the normal distribution of pre-test and post-test scores among

nurses. Paired t-tests were used to explore whether there was a significant difference

in knowledge scores at the two points. The average post–test score was one point

(95% CI: 0.5, 1.5) significantly higher than the pre-test score (df =18, t = -4.5, p <

0.001). This result indicated that the training workshop for nurses had shown a

positive effect on improving nurses’ general knowledge about HF and HF self-

management.

Four questions had correct responses less than 75% regarding fluid intake restriction,

cause of rapid HF worsening symptoms, function of the heart, and best thing to do in

case of thirst. These answers had improved at post-test (see Table 5.2). Half of the

participants continued to choose wrong answers regarding the cause of rapid HF

deterioration (high-fat diet or lack of exercise rather than getting a cold or flu). This

indicated that nurses were deficient in understanding the risk of flu or a cold to

people with heart failure, and thus required more education on this point.

Table 5.2 Common incorrect answers to the DHFKS

Questions % correct at

pre-test

% correct

at post-test

3. How much fluid are you allowed to take at home each

day?

63.2 85

6. What can cause a rapid worsening of heart failure

symptoms?

15.8 50

9. What is the function of the heart? 73.7 90

15. What is the best thing to do when you are thirsty? 68.4 85


5.2.3 Workshop evaluation

Nurses were invited to complete an evaluation form and provided comments to

improve the workshop in the future. Nineteen nurses returned the form (one nurse

had left the workshop before the evaluation was distributed). Blank pages were

provided for nurses to add comments for the following questions regarding:

1. The VALUABLE content of the workshop

2. The LESS VALUABLE contents of the workshop;

3. The MESSAGES participants would deliver to their colleagues.

These written comments are summarised using key words analysis.

The VALUABLE content of workshop

Thirteen nurses (65%) described that the teach-back method was very effective and

should be used to help nurses gain confidence in communicating with patients and to

create opportunities for patients to obtain feedback of their knowledge with nurses.

Nurses also wrote that they learned how to get the patients to summarise the

information given before completing the communication. All nurses indicated that

they gained better knowledge about heart failure and how to teach heart failure

patients about self-managing their condition. Three nurses commented that the case

studies and the role-playing were well-designed and that they helped participants

self-evaluate what they achieved after the workshop and what still remained to be

learned.

The LESS VALUABLE content of the workshop

Two nurses identified that implementation of the teach-back method to all patients

with heart failure in cardiac wards may be challenging, as they often face a high

clinical load of patients in wards. However, they agreed that nurses would prioritise


the teach-back method to particular patients, such as the elderly, people with low

reading skills, and minority groups.

The MESSAGES participants would deliver to their colleagues

Regarding messages to be shared with other people, participants made a number of

responses on the designated blank pages. All nurses indicated that they would share

the teach-back method with their team and colleagues. Eleven nurses indicated they

would show the HF booklet to colleagues, and discuss how to communicate

knowledge of HF symptoms and how to educate patients about the importance of

self-care. Three nurses were aware of the importance of assessing patients’ feedback

and understanding. One nurse said she would develop a flowchart for patients to

monitor their daily medicine use.

Evaluation of workshop contents

In addition to providing comments, nurses were asked to evaluate their agreement

with the structure and contents of the educational session using a five-point Likert

scale (strongly disagree, disagree, average, agree, and strongly agree). The frequency

of each scale was reported as a percentage.

All nurses (100%) either agreed or strongly agreed with all of the statements, except

regarding the length of the workshop. One individual gave feedback that a longer

workshop timeframe would have been valuable, as she wanted to learn more. Nurses

also indicated that they would use the teach-back method in their practice settings

(Item “I will use the teach-back method in teaching patients” 37% agreed, 63%

strongly agreed) and introduce the method to other colleagues (Item “I will introduce

the teach-back method to my colleagues” 37% agreed and 63% strongly agreed).

Overall, there were no items with which nurses disagreed or strongly disagreed (see

Table 5.3).


Table 5.3 Evaluation of workshop contents

Questions* (% agreement)

Neither

disagree or

agree

Agree Strongly

agree

1. The workshop was well organised. 0% 32% 68%

2. The workshop provided useful information. 0% 16% 84%

3. The length of the workshop was appropriate. 5% 53% 42 %

4. The workshop has provided me with a better

understanding about the teach-back method.

0% 21% 79%

5. The workshop has provided me with a better

understanding about self-management for HF.

0% 21% 79%

6. I am now confident in using the teach-back method

for health education for patients.

0% 42% 58%

7. I will use the teach-back method in teaching

patients.

0% 37% 63%

8. I will introduce the teach-back method to my

colleagues.

0% 37% 63%

Note. No participant answered ‘Strongly disagree’ or ‘Disagree’ to these items

5.3 RESULTS OF PHASE TWO: BRISLIN’S MODEL TRANSLATION AND VALIDATION

OF THE SELF-CARE OF HEART FAILURE INDEX V6.2

The Self-care for Heart Failure Index (SCHFI) v6.2 was used to measure the self-

care behaviour of the participants in Phase Three. The translation of the instrument

into Vietnamese was based on Brislin’s original model of translation, which has been

further developed through Sousa and Rojjanasrirat’s guidelines (Sousa &

Rojjanasrirat, 2011). The details of the methods were presented in Section 4.5.2,

Chapter 4. Steps 1 and 2 were the translation and backward translation of the SCHFI;

followed by Step 3, the comparison of the SCHFI and its backward English version.

Step 4 was an assessment of the content validity of the Vietnamese version of the

SCHFI (V.SCHFI) by an expert panel. Step 5 was a psychometric testing of the

V.SCHFI by a Vietnamese sample, which examined: 1) reliability (Cronbach’s


alpha); and 2) construct validity (by confirmatory factor analysis). The English

backward translation of the V.SCHFI is attached in Appendix 25.

5.3.1 Step 1-3: Translation of the SCHFI

Step 1: Forward translation

The instrument was sent separately to two independent translators and then they met

for a peer discussion about item differences. Prior to discussion with the forward

translators, the researcher reviewed the completed forward translated V.SCHFI to

identify disparities in word use, sentence structure, tense, and meaning. The two

forward translators then met with the researcher for 60 minutes to discuss both

translated versions and to reach agreement on the forward translation. In this

discussion, the noted disparities were pointed out between translators. A variety of

word selection and changes were made to complete the forward translated V.SCHFI

for back translation by the other two translators.

Several problematic items and words were identified in the peer discussion (see

Table 5.4). Two items were in the self-care maintenance subscale (Section A, item 8,

10), one item was in self-care management (Section B, item 13), and one word was

revised in the self-care confidence subscale (Section C, item 19). A word “được kê”

(prescribed) was added to item 8 to improve the clarity of “your medicines” and this

was agreed to by all reviewers. Three original words were suggested to change items

in the forward translation (item 10, 19, section B instruction statement). The word

“hệ thống” (system, item 10) was replaced by “phương pháp” (method), “lời

khuyên” (remedies, section B) was replaced by a word phrase “lời khuyên điều trị”

(treatment advice), and “đánh giá” (evaluate, item 19) was replaced by “nhận thức

được” (were aware of) to be more easily understood by people with a low level of

reading ability. The phrase “your fluid intake” was turned into a sentence structure


“lượng dịch ông/bà uống vào” (amount of fluid you take in) but still remained

equivalent in meaning. As “dịch” (fluid) is not a common word in Vietnamese casual

conversation, examples (e.g., tea, coffee, soup, and porridge) were added to make the

translated word clearer.

Step 2: Backward translation

Another two translators were invited to back translate the V.SCHFI. These two

translators were unfamiliar with the original instrument. Similar to Step 1, following

independent translation, a group discussion was held between the researcher and the

backward translators to compare their two translated versions. Any differences in

word use, sentence structure, and meanings were identified and discussed (see Table

5.5). Item 1 in Section A was different to the original English version. “Weigh” (item

1) was a verb, and it was turned to a noun in both back translations. “Quickly” (item

11, section B) was back translated into two different words, as “soon” and “early” by

two translators. It can be seen that most distortions in the two back translations were

caused by different word use. However, these changes did not change the meaning of

the entire sentences, so they were all accepted by the translators.

Step 3: Comparison of the original and back translated SCHFI

The original instrument and the pre-final backward translation were sent to the

supervisory team for discussion. Three words were found to be different to the

original version (section A). “Routinely” was translated into “thường xuyên” in

Vietnamese and then back translated into “frequently” in the English backward

version. Similarly, “frequently” was changed to “regularly”. As “routinely”,

“frequently”, “regularly” were all translated into the same Vietnamese “thường

xuyên” without any difference in degree of frequency, the supervisors noted these

distortions and suggested that the backward translators revise these items


accordingly. Another word difference was discovered in item 14 (section B). “Water

pill”, a simple non-technical word in English, was translated into “diuretic pill” in the

back-translation. In Vietnamese, there is only one translation “thuốc lợi tiểu” for both

“water pill” and “diuretic pill”. This is a Chinese-stem word that has no substitute, so

“diuretic pill” was accepted in back translation (see Table 5.6).


Table 5.4 Problematic words and phrases in forward translation process

Original statement Forward translator 1 Forward translator 2 Reviewer’s comments

and agreements made Backward statements

8. Forget to take one of

your medicines?

8.Quên uống một loại

trong số các loại thuốc

ông/bà được kê

8. Quên uống một loại

thuốc?

“Được kê” was added and

accepted for more clarity

Forget to take one of your

prescribed medicines?

10. Use a system (pill

box, reminders) to help

you remember your

medicines?

10. Lựa chọn một phương

pháp (hộp đựng thuốc,

báo thức) để nhắc ông/bà

uống thuốc

10. Sử dụng một hệ thống

(hộp đựng thuốc, giấy ghi

nhớ) để giúp ông/bà nhớ

các loại thuốc?

“Phương pháp” was used

instead of “hệ thống” for

ease of understanding

Use a method (eg: pill

container, notes) to

remind you to take

medicines.

Listed below are

remedies that people with

heart failure use. If you

have trouble breathing or

ankle swelling, how

likely are you to try one

of these remedies?

Dưới đây là một số lời

khuyên cho bệnh nhân

tim mạch. Nếu ông/ bà có

khó thở hoặc sưng mắt

các chân, ông bà có thử

áp dụng một trong các lời

khuyên này không?

Dưới đây là các cách

chữa trị mà người bị suy

tim dùng. Nếu ông/bà bị

khó thở hoặc sưng mắt cá

chân, khả năng có thể

ông/bà thử một trong

những cách chữa trị này

là?

“Lời khuyên” and “cách

chữa trị” were two

different translations of

“remedies”. There is no

direct word for remedies

in Vietnamese, so “lời

khuyên điều trị”

(treatment advice) was

used.

The following is some

treatment advice for

people with heart failure.

If you have trouble

breathing or swollen

ankles, would you try any

of the following treatment

advice?

13. Reduce your fluid

intake.

Uống giảm nước Giảm lượng dịch ông/bà

uống vào (ví dụ: trà, cà

phê, canh, súp…)

Fluid was translated as

“water” by translator 1,

which might mislead

patients. So, “dịch uống

vào” was used along with

examples (tea, coffee,

soup…) for more clarity.

Reduce the amount of

fluid you take in (ex. tea,

coffee, soup…)

19. Evaluate the

importance of your

symptoms?

Nhận thức về mức độ

quan trọng của các triệu

chứng

Đánh giá được tầm quan

trọng của các triệu chứng

ông/bà có?

Evaluate (đánh giá) is a

word requiring adequate

literacy to answer, so be

aware (nhận thức) was

replaced to suit people

with low literacy.

Be aware of the

importance of the

symptoms you have?


Table 5.5 Problematic words and phrase in backward translation process

Original

version

Pre-final Vietnamese Backward 1 Backward 2 Notes Backward statement

Section A

1. Weigh

yourself?

1.Tự kiểm tra cân nặng

của ông/bà?

1. Check your weight

by yourself?

1. Self-check your

weight?

Weigh in original version is a

verb and in back translation it

became a noun in both

translated items.

1. Check your

weight?

Section B

11. Have not

had these

Tôi không có các triệu

chứng này

I do not have these

symptoms?

I did not have these

symptoms

“I” was added so each answer

became a full sentence. This

was to help ease of

understanding for the elderly

and people with low literacy.

“Quickly” was back translated

to “soon” and “early”, but both

were agreed upon.

I did not have these

symptoms

I did not

recognise

Tôi không nhận ra I do not recognise I did not realise I did not recognise

Not quickly Tôi nhận ra muộn I recognised late I realised late I recognised late

Somewhat

quickly

Tôi nhận ra khá sớm I recognised quite

early

I realised quite soon I realised quite early

Quickly Tôi nhận ra sớm I recognised early I realised soon I recognised early

Very quickly Tôi nhận ra rất sớm I recognised very

early

I realised very early I recognised very early


Table 5.6 Distortion discovered by supervisory team

Original version Pre-final Vietnamese

Pre-final back

translated English

version

Supervisory team’s

comment Cause

Section A

Listed below are

common instructions

given to persons with

heart failure. How

routinely do you do the

following?

Dưới đây là những hướng

dẫn phổ biến cho người bị

suy tim. Ông/bà thực hiện

những điều này ở mức độ

thường xuyên như thế nào?

Following are common

instructions for people

with heart failure. How

frequently have you done

these instructions?

There is difference in

the meaning of

“routinely” and

“frequently”

“Routinely” is translated into “thường

xuyên” in Vietnamese, which was then

back translated into “frequently” in

English.

Frequently Thường xuyên Regularly There is difference in

meaning of

“frequently” and

“regularly”

Frequently was translated into “thường

xuyên” and back translated as

“regularly” in English, which did not

reflect “frequently”.

Section B

14. Take an extra water

pill

Uống thêm một viên thuốc

lợi tiểu

Take an extra diuretic pill Diuretic pill is a

technical word

“Thuốc lợi tiểu” is the only Vietnamese

word for both “water pill” and “diuretic

pill”. So no other simple word was

replaced.


5.3.2 Step 4: Content validity of the V.SCHFI

The panel who judged the content validity indexes (CVIs) of the V.SCHFI

instrument consisted of two cardiac nurses, one cardiologist, one general doctor, and

four general nurses. A primary teacher and an older person assisted with meanings of

items to ensure that they were clear and simple for people with low reading levels.

Health professional members then rated the CVIs regarding four aspects: relevance,

clarity, completeness, and adequacy. Items that achieved the CVIs at an item level

(item-CVI) of less than 0.78, or items suggested for changes by at least two panellists

were revised.

Scale and subscale content validity index

All subscale- and scale-level CVIs exceeded the acceptable cut-point of 0.9 (Polit et

al., 2007; Sousa & Rojjanasrirat, 2011) (see Table 5.7). All four aspects of the

V.SCHFI (relevance, clarity, completeness, adequacy of measuring scale) achieved

the sufficient CVI. Twenty of the 22 items achieved satisfactory item-level CVI (I-

CVI ≥ 0.78). Two items (questions 3 and 4) were below the item-level CVI cut-off

point (see Appendix 26 for all SCHFI item-level CVIs). These two questions were

then revised according to the recommended revisions by the expert panel.

Table 5.7 Scale and subscale CVI-Average

Subscale Relevance Clarity Completeness Adequacy

Maintenance CVI-Average 0.93 0.91 0.94 0.91

Management CVI-Average 1.00 1.00 1.00 0.93

Confidence CVI-Average 0.97 0.93 0.97 0.97

Scale level CVI- Average 0.96 0.94 0.96 0.93


Revisions made to items achieving an item-level CVI < 0.78

Item 3 rated a I-CVI below 0.78 in all four criteria and item 4 had a low I-CVI score

in the clarity criteria. Changes were made to these items to improve clarity. The “flu

shot” (item 3) is not commonly recommended to patients in Vietnam, as it is not

always available and affordable for the majority of people with heart failure. “Flu

shot”, was therefore deleted to make the item appropriate within the Vietnamese

context. “Physical activity” in item 4 was not specific to the heart failure community,

as it could mislead patients as effort–requiring exercise (item 7) rather than a normal

living activity. Examples such as “walking, doing light chores” were then added to

make the translated words more clear.

Revision made to other items suggested by panellists

Several items were revised to assist in clearer meaning. In item 7, examples of

exercise (Tai Chi, cycling) were added to differentiate between mentioned exercises

as health-related. In addition, it was acknowledged that individuals with heart failure,

especially those with low literacy, may not recognise water pills among other

medicines, so one of the common water pill names (furosemide) was added in item

14 to assist people in correctly answering regarding their behaviour responding to

“take an extra water pill”.

5.3.3 Step 5: Psychometric testing of the V.SCHFI

The baseline responses of participants to the V.SCHFI (Phase 3) were used to

analyse this instrument’s psychometric properties. First, the demographic

characteristics of participants were presented. Further participants’ characteristics are

presented in Chapter 5, section 5.4.3. Second, internal consistency of the V.SCHFI

was assessed using Cronbach’s alpha coefficients. Next, confirmatory factor analysis


was examined to affirm the 3-factor structure of the V.SCHFI. The V.SCHFI

psychometric properties were compared to profiles of the SCHFI tested in other

languages.

Social demographic characteristics

The social demographic characteristics of the participants are summarised in Table

5.8. Among the 140 participants, there was a relatively equal distribution of males

(46.4%) and females (53.6%). The average age of all respondents was 54.4 years (SD

=12.2), ranging from 19 to 79 years. The majority of respondents were married

(87.1%), while the others were single, divorced, or widowed. Only 2.9% respondents

had not been to school, and slightly more than half of the participants had completed

primary school and secondary school (54.3% collectively). The proportion of people

with a completed high school education and higher was 42.8%. Large numbers of

participants were farmers and retired people (39.3% and 28.8%, respectively).

Table 5.8 Social demographic characteristics

Characteristics N = 140

Age (years), mean (SD) 54.4(12.2)

Gender, n (%)

Female 65 (46.4)

Male 75 (53.6)

Marital status, n (%)

Single/ Divorce/ Widow 18 (12.9)

Married 122 (87.1)

Education, n (%)

Lower high school 106 (75.7)

Upper high school 34 (24.3)

Occupation, n (%)

Unemployed and retire 53 (37.9)

Unskilled job 67 (47.9)

Professional job 20 (14.3)

Insurance cover, n (%)

100% reimbursed 36 (25.7)

Partly reimbursed 86 (61.4)

Self-paid 18 (12.9)


Cardiac disease history

Nearly half of the respondents had previously received some information about HF

(47.1%) from their medical doctors. Half of respondents (46.4%) were diagnosed

with HF for less than one year, and those diagnosed between 1-5 years prior

comprised 30.7%. Participants with valvular disease origin comprised 44.7% of the

group. The most commonly recorded comorbid conditions were hypertension

(28.6%), followed by kidney failure (10%), diabetes (9.3%), and liver disease

(2.1%). Half of the respondents suffered from HF at NYHA level III (55.7%); those

at level II and IV were 35% and 9.3%, respectively. Most people had at least one co-

existing condition, those with a moderate comorbidity index were 47.9%, whereas

people with a low and high comorbidity index were 24.3% and 27.8%, respectively

(see Table 5.9).


Table 5.9 History of cardiac disease

Characteristics N = 140

Medication (mean, SD) 6 (1.9)

Length of stay (mean, SD) 10.7 (6.7)

Valvular disease, n (%) 63 (45)

Time since HF diagnosis, n (%)

≤ 3 months 31 (22.1)

≤ 1 years 34 (24.3)

1-5 years 43 (30.7)

≥5 years 32 (22.9)

Co-existing disease, n (%)

Hypertension 40 (28.6)

Diabetes 13 (9.3)

Kidney Failure 14 (10)

COPD/asthma 3 (2.1)

Liver disease 3 (2.1)

NYHA, n (%)

II 49 (35)

III 78 (55.7)

IV 13 (9.3)

Comorbidity, n (%)

Low (1-2) 34 (24.3)

Moderate (3-4) 67 (47.9)

High (>4) 39 (27.8)

Previous HF consultancy, n (%)

Yes 74 (47.1)

No 66 (52.9)

Note. COPD: chronic congestive pulmonary disease,

NYHA: New York Heart Association category


Responses to the V.SCHFI

The distribution of participant responses to the V.SCHFI at baseline is presented in

Table 5.10. The answers were scored from 1 to 4 in accordance with increasing

levels of frequency. Higher scores in each item indicated better self-care behaviour in

that item. Responses to the four major groups of items regarding heart failure self-

care are summarised below.

Medication. Most participants reported that they took their medications as

prescribed (65%), while 35% reported they sometimes or regularly forgot to take

their medications (item 8). Less than half of the participants used tools (pill boxes,

alarms) to remind them to take their medications (item 10).

Exercise. A high rate of exercise was reported, and 83.6% of participants claimed to

be doing regular exercise (item 4).

Weight monitoring. Weight monitoring was irregular in most participants, while a

small proportion of people weighed themselves daily (12.9%). Twenty-one percent

of respondents addressed that they never or rarely weighed themselves (item 1).

Sodium restriction. Self-care with regard to a sodium restricted diet was relatively

high, with 75.7% adhering to a low-salt diet. Overall, 12.1% participants still did not

follow sodium restriction advice (item 6).


Table 5.10 V.SCHFI items responses

% respondent

Items 1 2 3 4

Section A Never or rarely Sometimes Frequently Always or daily

1. Weigh yourself? 20.7 65 12.9 1.4

2. Check your ankles for swelling? 35.7 24.3 15 25

3. Try to avoid getting sick (e.g., flu shot, avoid ill people)? 10.7 39.3 40.7 9.3

4. Do some physical activity? 0.7 2.1 13.6 83.6

5. Keep doctor or nurse appointments? 23.6 17.1 42.1 17.1

6. Eat a low salt diet? 12.1 4.3 7.9 75.7

7. Exercise for 30 minutes? 36.4 17.9 8.6 37.1

8. Forget to take one of your medicines? 65 32.1 1.4 1.4

9. Ask for low salt items when eating out or visiting others? 46.4 29.3 14.3 10

10. Use a system (pill box, reminders) to help you remember your

medicines?

32.1 12.1 6.4 49.3

Section B Not likely Somewhat likely Likely Very likely

11. How quickly did you recognise it as a symptom of heart

failure?

23 18 36 23

12. Reduce the salt in your diet 4.3 2.9 35 57.9

13. Reduce your fluid intake 20 10 50 20

14. Take an extra water pill 32.9 9.3 46.4 11.4


15. Call your doctor or nurse for guidance 22.1 4.3 46.4 27.1

16. How sure were you that the remedy helped or did not help? 5.7 33.6 52.1 8.6

Section C Not confident Somewhat Very Extremely

17. Keep yourself free of heart failure symptoms? 27.1 42.1 25 5.7

18. Follow the treatment advice you have been given? 0 14.3 63.6 22.1

19. Evaluate the importance of your symptoms? 2.1 57.1 32.1 8.6

20. Recognise changes in your health if they occur? 1.4 27.1 60.7 10.7

21. Do something that will relieve your symptoms? 22.9 37.9 35 4.3

22. Evaluate how well a remedy works? 7.9 40 44.3 7.9

Note. Question 11: Answers were “Have not had these” (N/A), “I did not recognise” (0), “Not quickly” (1), “Somewhat quickly” (2), “Quickly” (3), “Very quickly”

(4). Question 16: Answers were: “I did not try anything” (0), “Not sure” (1), “Somewhat Sure” (2), “Sure” (3), “Very sure” (4). Answers to 0 (I did not recognise it)

and 1 (Not quickly) in question 11 and 16 were combined.


Internal consistency of the V.SCHFI

Firstly, the coding of responses to item 8 was reversed following the SCHFI author’s

scoring instructions (Riegel et al., 2009). Each subscale score was calculated to a

standardised range from 0 to 100. The higher scores indicated better self-care

capacity. A cut-point of 70 and over was considered self-care adequacy. The mean

score of self-care maintenance was 57.3 (SD =13.7); self-care management was 62.5

(SD =17.0) and self-care confidence was 51.0 (SD =17.7). Cronbach’s alpha was

used to determine the internal consistency coefficients of each V.SCHFI subscale.

No cumulative Cronbach’s alpha was calculated for the entire SCHFI on the

instrument author’s recommendations (Riegel et al., 2009). Cronbach’s alpha

coefficients were 0.47 for the self-care maintenance, 0.57 for the self-care

management and 0.82 for the self-care confidence of the V.SCHFI. Only the self-

care confidence coefficient was deemed acceptable (≥ 0.78). Deletion of any items

from the three subscales of self-care did not improve the coefficient to 0.1. Table

5.11 presents the scores and Cronbach’s alpha coefficients of each subscale.

Table 5.11 Internal consistency of the V.SCHFI subscales

Subscales Items Mean (SD) Range V.SCHFI

Cronbach α Potential Actual

SCHFI Maintenance 10 57.3 (13.7) 0-100 20-89.99 0.47

SCHFI Management 6 62.5 (17.0) 0-100 15-95 0.57

SCHFI Confidence 6 51.0 (17.7) 0-100 16.68-100 0.82

Note. Self-care management score was calculated only for 100 people who answered “Yes” to “Have

had trouble breathing or ankle swelling in last month”.


Confirmatory factor analysis (CFA)

The CFA (using SPSS Amos version 22) was used to assess the construct validity of

the V.SCHFI. Scores of self-care management were calculated only for people who

answered “Yes” to the question regarding their experience of either trouble breathing

or ankle swelling in the last month (item 11), according to the instrument author’s

instructions. Therefore, CFA was conducted with the data from 100 people who were

eligible for self-care management score calculations. The tested model consisted of

three components: self-care maintenance, management, and confidence. Items in

each component were the same as those in the original instrument. Goodness-of-fit

indices showed a significant model, indicating the current data did not fit well to the

3-factor model of the V.SCHFI. The model fit indices were Chi-square (206, d.f.) =

337.9, p <0.001, CFI = 0.7, RMSEA = 0.08 (see Table 5.12). Absolute values of

factor loadings of the V.SCHFI items were from 0.11-0.79. Correlation coefficients

of self-care confidence with self-care maintenance and self-care management were

0.65 and 0.84, respectively (see Figure 5.1).

Table 5.12 Goodness-of-fit model indices of the V.SCHFI

Index Fit model

criteria

V.SCHFI

indices

CMIN/df < 3 1.64

P value ≥ 0.05 <0.001

Normal fit index (NFI) > 0.95 0.51

Comparative fit index (CFI) > 0.95 0.70

Root mean square error of approximation (RMSEA) < 0.05 0.08

PCLOSE ≥ 0.05 0.001

Note. CMIN/df: Chi square/degree of freedom, PCLOSE: p value for the null hypothesis RMSEA ≤

0.05


Figure 5.1 Confirmatory factor analysis of the V.SCHFI

Note. The figure displays the loading for the various indicators of latent constructs: self-care maintenance, self-care management, and self-care confidence. Numbers in

the first line of boxes refer to SCHFI item numbers. Self-care confidence was correlated to self-care management and self-care maintenance. The standardised numbers

in the second line reflect the strength of the relationship between each item and construct (subscale) on which it loads. The model does not fit the data well.


Comparison of the SCHFI psychometric properties in other languages

The psychometric properties of the V.SCHFI were compared with those of previous

studies testing the instrument in other languages, as shown in Table 5.13. The

Cronbach’s alpha of the V.SCHFI self-care maintenance was lower (0.47 vs 0.55),

while the coefficients of the two other subscales were almost similar to those of the

original SCHFI. All mean scores of three V.SCHFI subscales achieved in this current

study were lower than the scores of the original study sample. Self-care maintenance

scores in Vietnamese participants were comparable to those obtained in a Brazilian

study (57.3±13.7 vs 57±14.3, respectively) (Ávila et al., 2013). The management

score was relatively equal to that in a Persian sample (62.5 vs 62.1 respectively)

(Siabani et al., 2014). The confidence score was seen to be lower than those obtained

in other listed studies (Ávila et al., 2013; Riegel et al., 2009; Siabani et al., 2014).


Table 5.13 Comparison of psychometric properties of the SCHFI in different languages

Language N

Cronbach’s

alpha of 3

subscales

χ2 Df

CFI NFI RMSEA p

Mean score

Self-care

maintenance

Self-care

management

Self-care

confidence

English (USA)

(Riegel et al., 2009)

154 0.55, 0.59, 0.82 356.9 0.73 0.55 0.07 -- 70 ±14.3 63±22.6 70±16.2

Portuguese (Brazil)

(Ávila et al., 2013)

128 0.4, 0.82, 0.93 520.4 207 0.77 0.68 0.11 0.001 57 ±14.3 47 ±28.3 58 ±25.5

Persian (Iran)

(Siabani et al., 2014)

184 0.56, 0.64, 0.79 283 206 0.91 -- 0.05 0.001 54.1±6.6 62.1±4.6 52.4 ±13.1

Vietnamese (Vietnam)

(current study)

140 0.47, 0.57, 0.82 337.9 206 0.7 0.51 0.08 0.001 57.3±13.7 62.5±17.0 51.0 ±17.7

Note. χ2 = Chi-square, Df: degree of freedom, CFI: comparative fit index, NFI: Normal Fit Index, RMSEA: Root mean square error of approximation


Confirmatory factor analysis for each subscale

Next, three CFAs were separately performed for each subscale: self-care

maintenance [n= 140], self-care management [n = 100] and self-care confidence [n =

140]. The CFA model for the self-care maintenance subscale consisted of four

factors: symptom monitoring (items 1 and 2), physical activity (items 4 and 7),

sodium intake (items 6 and 9) and medical treatment adherence (items 3, 5 and10).

The CFA model for self-care management subscale included two factors: evaluation

(items 11 and 16) and implementation (items 12, 13 and 15). The testing model of

self-care confidence assumed it was unidimensional (Barbaranelli, Lee, Vellone, &

Riegel, 2014). The two first models failed to perform in SPSS Amos, as the models

were unidentified (the sample size was not sufficient). The self-care confidence

model was a better fit to the data (CMIN/df = 2.7, p = 0.004, CFI = 0.94, NFI = 0.91,

RMSEA = 0.11, PCLOSE = 0.03). When the covariance was permitted between item

17 (Keep yourself free of heart failure symptoms) and item 18 (Follow the treatment

advice you have been given), an excellent fit model of self-care confidence was

demonstrated (CMIN/df = 1.56, p = 0.13, CFI = 0.98, NFI = 0.95, RMSEA = 0.06,

PCLOSE = 0.32).

Conclusion

The psychometric properties of the V.SCHFI have been validated in this phase two.

The self-care confidence subscale is reliable and valid. The self-care management

and self-care maintenance subscales need further testing of reliability and construct

validity. The V.SCHFI psychometric properties showed consistency with other

language versions of SCHFI, and that supported the use of V.SCHFI to measure self-

care of Vietnamese people with heart failure.


5.4 RESULTS OF PHASE THREE: A SELF-MANAGEMENT PROGRAM FOR PEOPLE

WITH HEART FAILURE: A CLUSTER RANDOMISED CONTROLLED TRIAL

This phase was a cluster randomised controlled trial (cRCT). The aim of this phase

was to implement a self-management educational program for people with HF in

Vietnam, using the teach-back method as a teaching tool to deliver the intervention

and to examine the effectiveness of the intervention. Primary outcomes of interest

were changes in HF knowledge and self-care measured by validated questionnaires.

Secondary outcomes were hospital readmission/death measured by participants’

reports. Units of randomisation were inpatient wards (clusters) in a leading cardiac

hospital to avoid risk of contamination between study participants. The intervention,

however, was delivered individually to each participant, and study outcomes were

measured and interpreted at the individual level.

The three alternative hypotheses tested in the trial were:

1. People who receive a self-management program will have greater HF

knowledge compared to those receive standard care.

2. People who receive a self-management program will have higher HF self-

care scores compared to those who receive standard care.

3. People who receive a self-management program will have a lower number

of hospital readmissions and/or deaths compared to those who receive

standard care.


5.4.1 Data preparation

Data were entered into SPSS v21 and assessed for missing data, outliers, and typing

errors. Categorical demographic responses were coded and continuous values were

inputted. Total scores of HF knowledge and self-care at three repeated measures

were computed using formulas suggested by the instruments’ authors (Riegel et al.,

2009; Van Der Wal et al., 2005). Body Mass Index (BMI) was calculated by dividing

weight by height multiplied by meters squared. Estimated glomerular filtration rates

(eGFR) were individually calculated for each participant using their data of age,

gender, and serum creatinine level (CKD–EPI Creatinine 2009 Equation).

For quality assurance, a twenty percent sample of participants’ records were

randomly reviewed by the lead researcher in SPSS to ensure the reliability of data

entry. Frequency analysis was undertaken to explore any missing or outlier numbers.

No missing data were found in social demographic data and responses to the DHFKS

and V.SCHFI at baseline. The missing rate of clinical measures (HbA1C, BP, BNP,

etc.) varied from 2.1% to 69.3%, which was explainable, because specific tests were

not indicated for all participants, or test results were not available in medical records

at the time of data collection. Therefore, analysis of these data would be only

conducted on those with available measures. Shapiro-Wilk tests of normality were

undertaken to explore the distribution of continuous variables, as shown in Appendix

27. In addition, histograms and plots of these variables were detailed in Appendix 28.

Self-care maintenance and confidence scores showed normal distribution.

The missing response rate for all participants at two occasions of questionnaire

distribution (at 1st and 3

rd month) were 37.9% and 24.3%, respectively. Seven

participants (10%) in the intervention group had died by the study’s end-point

compared to nine people (12.8%) in the control. Two participants in the intervention


withdrew or were unable to speak with the researcher as a consequence of

cardiovascular accidents. Two participants in the control group withdrew in the first

month. Five people (7.1%) in the intervention group, and nine people (12.8%) in the

control group dropped out for unknown reasons. Participants either missed or were

not eligible for self-care management scores at the three data collection time points

(28.6%, 84.3%, and 77.9%, respectively). As the calculation of self-care

management was only applicable to symptomatic participants (those who

experienced trouble breathing or ankle swelling), missing responses in this variable

were predicted (Riegel et al., 2009).

In this study, people withdrew, died, or were lost to follow-up, which resulted in

their data being missing. Replacement of missing data using single or multiple

imputation techniques for these cases might give misleading information (Sterne et

al., 2009). The linear mixed models using available data analysis techniques were

approached in analysis of continuous outcomes (HF knowledge and self-care)

(Armijo-Olivo et al., 2009; Gadbury et al., 2003). Data was then transformed from a

wide format to a long format to prepare for the linear mixed-effect model procedures.

The linear mixed-effect models were used to explore the changes in knowledge and

three self-care subscale variables in two groups over three time points. The outcome

of hospital readmission/death was a binary variable, therefore, missing values in this

outcome were replaced with either “no event” or “at least one event”, while “event”

indicated a readmission or death. The dataset was ready for descriptive and further

analyses.

5.4.2 Recruitment, group allocation and follow-up

Hospital records of 353 people admitted with initial diagnosis of heart failure in six

participating wards from July to November 2014 were screened for eligibility.


Exclusions included people who did not have confirmed heart failure, were pregnant,

critically ill, and visually, verbally, or cognitively impaired, or who declined to

participate. Recruitment continued until a targeted number of 140 eligible people was

achieved. People received the self-management program or control care on the basis

of the allocation status of their ward. The research flow is presented in Figure 5.2.

Figure 5.2 Research process

Note. Adapted from CONSORT flow chart for cluster randomised trials (Campbell et al., 2012)

Assessed for eligibility

n = 353

Excluded (n= 213)

Answered: n=43

Missed: n = 22

Declined: n= 1

Death: n = 4

Intervention

group (3 wards),

n = 70

Death: n = 5

Control group

(3 wards), n =70

Answered: n = 44

Missed: n = 21

Allocation

1st Assessment

Randomised (6 wards) Enrolment

2nd

Assessment

Declined: n= 2

Death: n = 7

Unable to

contact: n = 5

Declined: n= 2

Death: n = 9

Unable to

contact: n = 9

Answered: n = 50

Analysed: n = 70

Answered: n = 56

Analysed: n = 70


5.4.3 Baseline characteristics

The baseline characteristics of the two groups are presented in three separate

sections: social demographic characteristics, clinical characteristics, biochemistry

and anthropometric measurements. Statistical tests, including Chi-square, Fisher-

exact test, one-way ANOVA or unpaired t-test, and alternative non-parametric tests

were used to explore any differences between the two groups at baseline.

Social demographic characteristics

Analyses of social demographic characteristics included age, gender, marital status,

qualifications, occupation, and insurance status (see Table 5.14). The average age of

the intervention group was 52.9 years (SD = 11.6), which was slightly younger than

those in the control group (55.9 years, SD = 12.7), although this difference was not

significant (t (138) =-1.48, p=0.14). Sixty percent of the intervention group vs 47.1%

of the control group were males. Most participants were married (90% in

intervention vs 84.3% in the control group), which did not differ significantly. The

majority of people in both groups completed a high school education or lower (70%

and 81.4%, respectively in the intervention and control). Unskilled occupations

(farmer, factory workers) or those who were unemployed or retired were common in

the two groups (both 85.7%). A greater proportion of the control group had insurance

arrangements, that reimbursed the total or a part of their treatment cost (78.5% in the

intervention and 88.6% in the control group). There were no significant differences

in demographic characteristics between the two groups at p–value levels equal or less

than 0.05.


Table 5.14 Social demographic characteristic of two groups

Characteristics Intervention

n=70

Control

n=70

P value

Age (years) mean (sd) 52.9 (11.6) 55.9 (12.7) 0.14a

Gender, n (%)

Male 42 (60) 33 (47.1) 0.13

Female 28 (40) 37 (52.9)

Marital status, n (%)

Single/ Divorce/ Widow 7 (10) 11 (15.7) 0.31

Married 63 (90) 59 (84.3)

Education, n (%)

Lower high school 49 (70) 57 (81.4) 0.11

Upper high school 21 (30) 13 (18.6)

Occupation, n (%)

Unemployed and retired 29 (41.4) 24 (34.3) 0.65

Unskilled job 31 (44.3) 36 (51.4)

Professional job 10 (14.3) 10 (14.3)

Insurance status, n (%)

100% reimbursed 15 (21.4) 21 (30) 0.65

Partly reimbursed 42 (60) 44 (62.9)

Self-paid 13 (18.6) 5 (7.1)

Note. a Independent t-test, other tests were Chi-square test

Clinical characteristics

Clinical characteristics of the participants included number of medications being

used, length of hospital stay, time since HF diagnosis, co-existing conditions,

comorbidity index, and New York Heart Association categories of heart failure

(NYHA). Newly diagnosed people with HF for less than one year were 54.3% in the

intervention group compared to 38.6% in the control group. The most frequent co-

existing condition was hypertension (27.1% in the intervention and 30% in the

control group). The distribution of NYHA categories and co-morbidity revealed

similarities between the two study groups (see Table 5.15). No significant difference

was found in cardiac characteristics between the two groups, except that the number

of participants with cardiac valvular disease in the control group (55.7%) was

significantly higher than that of the intervention group (32.9%) (χ2

= 7.04, p= 0.008).


Biochemistry and anthropometric characteristics

Biochemistry measurements were compared among participants in the two study

groups (see Table 5.16). Means and standard deviations were used to describe

parametric variables (normally distributed). Medians and interquartile ranges were

used for non-parametric variables. The ejection fraction was significantly greater in

the control group (df=99, t=-2.2, p=0.03) and higher HbA1C was seen in the

intervention group (U=143.5, p=0.04). Other examination results did not indicate any

statistical difference between the two groups.

Table 5.15 Clinical characteristics

Intervention

n=70

Control

n=70

P

value

Valvular disease, n (%) 23 (32.9) 39 (55.7) 0.008

Medication, mean, (SD) 5.9±2.1 6.1±1.8 0.59a

Length of stay, median (range) 9 (7-11.5) 9 (5 -15) 0.68b

Time since HF diagnosis, n (%)

≤ 3 months 18 (25.7) 13 (18.6) 0.27

≤ 1 years 20 (28.6) 14 (20)

1-5 years 17 (24.3) 26 (37.1)

≥5 years 15 (21.4) 17 (24.3)

Co-existing disease, n (%)

Hypertension 19 (27.1) 21 (30) 0.70

Diabetes 8 (11.4) 5 (7.1) 0.36

Kidney Failure 6 (8.6) 8 (11.4) 0.59

COPD/asthma 1 (1.4) 2 (2.9)

Liver disease 1 (1.4) 2 (2.9)

NYHA, n (%)

II 23 (32.9) 26 (37.1) 0.85

III 40 (57.1) 38 (54.3)

IV 7 (10) 6 (8.6)

Comorbidity, n (%)

Low (1-2) 18 (25.7) 16 (22.9) 0.64

Moderate (3-4) 35 (50) 32 (45.7)

High (>4) 17 (24.3) 22 (31.4)

Previous HF consultancy, n (%)

Yes 40 (57.1) 34 (48.6) 0.31

No 30 (42.9) 36 (51.4)

Note. a Independent t-test,

b Mann-Witney U test; other tests were Chi-square test. COPD: chronic

congestive pulmonary disease, NYHA: New York Heart Association category


Table 5.16 Baseline biochemistry and anthropometric characteristics

Current clinical test

Intervention

Control P-valuea

N=70 N= 70

Median, IQR

Blood glucose (umol/l) 5.7 (4.9-8.1) 5.5 (4.6-6.8) 0.29

HbA1C (%) 5.8 (5.4-6.2) 5.3±0.7 0.04

Creatinine (umol/l) 103.5 (87-121) 97 (87.2-114.5) 0.49

Pro-BNP (pmol/l) 465.7 (159.7-1213) 236 (85-943.5) 0.11

Systolic pressure (mmHg) 120 (110-130) 110 (105-130) 0.92

Diastolic pressure

(mmHg)

70 (65-80) 70 (60-80) 0.83

Mean, SD

eGFR(ml/min/1.73m2) 64±19 63±21 0.74

Hb (g/dl) 136.9±19.2 133 (124-146) 0.3

Ejection fraction (%) 41.5±17.1 49.1±16.7 0.03

N (%)

eGFR ≤ 60 29 (42.4) 24 (34.3) 0.37

Anaemia 23 (32.8) 29 (41.4) 0.25

BMI < 18.5 16 (22.9) 14 (20) 0.66

BMI 25 – 29.9 5 (7.1) 6 (8.6)

BMI ≥ 30 1(1.4) 0

Notes. Anaemia is defined as ≤ 120 g/dl (female) or ≤140 g/dl male. IQR: interquartile range; eGFR:

estimated glomerular filtration rate; BNP: Beta-type natriuretic peptide; BMI: body mass index. Not

all participants available, denominator varied. aIndependent t test, Mann Witney U test or Chi square

test.

5.4.4 Characteristics of participants lost to follow-up

Over the duration of three months, 34 participants dropped out across both groups.

The reasons for attrition are listed in Table 5.17. There were 16 people who died,

four who declined to answer due to being too sick, and 14 people were lost to follow-

up. Attrition in health care trials is a common problem; however, any systematic

differences between those who dropped out and those stayed in the study will have

an impact on the interpretation of study results. Analysis of the baseline demographic

and clinical characteristics of the 34 participants who dropped out were compared

with those obtained in the participants who stayed at end-point. Examined variables

included age, gender, marital status, educational level, occupation, insurance,

NYHA, comorbidities, clinical measures, and baseline HF knowledge and self-care.

Comparison tests indicated there were similarities between those who dropped out


and those who stayed in the study and no significant differences were found (see

Appendix 29).

Among 14 participants who were lost to follow-up, most were males (71.4%),

completed lower high school (85.7%), and were unemployed or unskilled employees

(100%). Five participants were diagnosed with hypertension and one with kidney

failure. Nine of 14 participants were newly diagnosed with heart failure (less than

one year). Compared to people who stayed until the end point of the study, these 14

participants had a lower level of estimated GFR (60.1 vs 64.6 ml/l/1.73m2), had

greater levels of pro-BNP at baseline (543.4 vs 356 pmol/l), and slightly lower HF

knowledge (7.7 vs 8.7) and self-care score maintenance (55.5 vs 58.1). Other

important characteristics, including age, HF categories, comorbidity index, and other

clinical data of these 14 people were found to be similar to those of the participants

who stayed at the end-point (see Appendix 29).


Table 5.17 Reasons for attrition in two groups

Note. Y: provided data, N: not provide data

ID Baseline 1st month (time 1) 3

rd month (time 2) Reason for attrition

Intervention

021 Y Y N Died before time 2

023 Y N N Unable to contact

071 Y N N Died before time 1



082 Y Y N Unable to contact







127 Y N N Declined to answer


Control








048 Y N N Declined to answer














5.4.5 Baseline HF knowledge and self-care scores

Primary outcomes of the study were HF knowledge (measured by DHFKS) and self-

care (measured using V.SCHFI). The HF knowledge score of each participant was

the sum of correct item scores; each was rated 1. Each V.SCHFI subscale score was

calculated using formulas suggested by the SCHFI’s author and was standardised to

a range of 0 – 100 (see Chapter 4, page 91) (Riegel et al., 2009). Self-care

maintenance and confidence scores were calculated for all participants (n=140). The

self-care management score was calculated only for people who answered “Yes” to

symptoms experienced in the last month (n=100) (Riegel et al., 2009). Histograms of

HF knowledge and three self-care variables were seen to have normal distribution;

therefore, means and standard deviations were used to describe these variables.

Independent t-tests were employed to determine the baseline differences in HF

knowledge and three self-care variables between the two groups. The HF knowledge,

self-care maintenance, and self-care management were not significantly different

between the two groups at p < 0.05. The confidence score differed significantly in

two groups (mean difference = 10.2, 95% CI: 4.5 – 15.9, p = 0.001) (see Table 5.18).

Table 5.18 Baseline HF knowledge and self-care scores

Possible

score

Mean (SD)

Test valuea

Intervention

N =70

Control

N=70

HF knowledge 0-15 8.9 ±2.1 8.4±2.1 df = 138, t=1.61, p = 0.11

Maintenance 0-100 59.4±13.6 55.3±13.6 df = 138, t=0.76, p = 0.08

Management 0-100 65.1±13.8 59.9±19.5 df=98, t=1.53, p=0.13

Confidence 0-100 56.2±18.3 45.9±15.7 df=138, t = 3.55, p = 0.001*

Note. a Independent t tests, *significant at p ≤ 0.01


Difference between HF knowledge and self-care by demographic characteristics

The descriptive analysis of HF knowledge and three dimensions of self-care scores

categorised by gender, marital status, education level, occupation, insurance cover,

and time since HF diagnosis, HF categories by NYHA, or recipients of previous HF

counselling are shown in Table 5.19. Independent t-test and ANOVA were used to

determine the mean difference of HF knowledge and self-care by gender, marital

status, education level, occupation, insurance cover, time since HF, HF categories by

NYHA, or recipients of previous HF counselling if the assumption of homogeneity

of variance was not rejected. Non parametric tests including Mann-Witney U test and

Kruskal Wallis were used if that assumption was violated.

People who completed graduate training had higher HF knowledge than people who

had high school or lower education qualifications (p < 0.05). People who paid

insurance permitting total reimbursement of hospital cost had lower knowledge of

heart failure than people who received partial reimbursement (p < 0.05). Level of

self-care maintenance in heart failure differed among people with various

occupations was lower in those working in unskilled sectors than those working in

professional jobs (p < 0.01). Married people were seen to perform self-care

management better than those were single or divorced (p < 0.01). Males and people

with higher education had greater confidence in self-care than females and those with

lower school education (both p < 0.01).


Table 5.19 Associations of demographic factors to HF knowledge and self-care

Categories N HF knowledge Maintenance Management Confidence

Gender Male 75 8.6±2.1 59.0±12.9 65.1±16.1 55.3±16.8

Female 65 8.6±2.1 55.4±14.4 59.4±17.8 46.1±17.5

Marital status Single/divorce 18 8.4±1.7 55.2±13.4 51.1±18.7 51.3±18.0

Married 122 8.7±2.1 58.1±13.6 64.2±16.2 50.9±17.8

Education Graduate and upper 34 9.3±2.1 60.8±15.2 66.1±14.4 58.7±19.2

High school and lower 106 8.4±2.1 56.2±13.0 61.2±17.8 48.6±16.5

Occupation Unemployed and retired 53 8.4±2.2 58.4±14.4 59.6±15.8 51.8±19.9

Unskilled job 67 8.5±2.0 54.8±13.4 62.6±17.8 48.4±15.7

Professional job 20 9.6±1.8 62.9±11.0 69.0±16.7 57.8±16.9

Insurance cover Total reimbursement 36 7.9±1.9 57.1±14.6 60.4±17.2 50.3±19.9

Partly reimbursement 86 8.9±2.2 57.9±13.1 62.9±16.8 51.6±16.7

Self-payment 18 8.6±1.6 54.9±14.7 64.2±18.7 51.0±17.7

Time since HF ≤ 3 months 31 8.3±1.8 56.0±15.9 60.2±19.4 50.0±17.6

≤ 1 year 34 8.5±2.2 56.3±12.7 62.8±16 48.7±17.0

1-5 years 43 8.7±2.5 58.1±12.8 62.8±18.2 52.1±17.5

≥ 5 years 32 8.9±1.7 58.6±13.9 60.1±17.1 52.9±17.4

NYHA II 49 8.5±2.3 55.9±14.1 63.5±14.9 51.2±17.5

III 78 8.6±1.9 57.1±13.1 63.5±14.9 50.6±18.1

IV 13 9.1±1.9 64.1±14.9 64.5±15.4 53.0±17.4

Previous HF consultancy Yes 74 8.8±2.3 59.2±12.5 64.3±16.3 53.6±17.1

No 66 8.5±1.9 55.2±14.7 60.1±17.8 48.1±18.1

Note. HF: Heart Failure, NYHA: New York Heart Association, **p < 0.05, *** p <0.01. Number of participants varied for calculations of self-care management scores

**

**

**

***

***

***


Correlations between HF knowledge and self-care to age, HF severity (pro-BNP

level), ejection fraction, and comorbidity index

Bivariate statistical analysis between continuous variables was conducted to

investigate the correlations between heart failure knowledge and three self-care

dimension scores with age, heart failure severity (pro-BNP level), ejection fraction,

and comorbidity index (see Table 5.20). Age was negatively correlated with heart

failure knowledge, self-care management, and confidence, but was positively

correlated with self-care maintenance. HF severity was positively correlated with

heart failure knowledge, self-care management, and confidence, and was negatively

correlated with maintenance. Ejection fraction was seen to be positively correlated

with HF knowledge but negatively to self-care. The comorbidity index was

negatively correlated with HF knowledge and all dimensions of self-care. No

correlation coefficients were significant at p ≤ 0.05.

Table 5.20 Correlation coefficients of HF knowledge and self-care to age, pro-

BNP level, ejection fraction, and comorbidity index

Correlation

coefficients HF knowledge Maintenance Management Confidence

Age -.012 0.02 - 0.08 - 0.05

Pro-BNP 0.07 - 0.006 0.08 0.13

Ejection fraction 0.16 - 0.09 -0.11 - 0.31

Comorbidity index - 0.11 - 0.02 - 0.08 - 0.09

Note. No correlation was significant at p ≤ 0.05

5.4.6 Effects of the self-management program on HF knowledge

Linear mixed effect models are advanced statistical methods used to examine

changes in continuous variables in cluster randomised trials (Campbell et al., 2012;

Eldridge & Kerry, 2012). In this study, mixed models were conducted to examine the

effects of the intervention and standard care on HF knowledge and self-care score.


Firstly, the covariance structure that best fit the current dataset was tested. Initial

models were run with only intercepts and fixed factor (intervention). Three common

covariance structures tested included “unstructured”, “compound symmetry”, and

“first-order autoregressive”. Akaike’s Information Criterion (AIC) value indicated

which model best fit the data with a smaller-is-better principle. Three models using

three different covariance structures yielded similar AIC values; therefore,

unstructured covariance structure was selected, as it was appropriate for repeated

data. The model was then rerun to identify which study groups differed in HF

knowledge. The model included fixed effects consisting of group allocation, time,

and group-time interaction. Wards of participants were considered as a random effect

in the model.

Assuming an unstructured covariance structure, the fitted model indicated that the

knowledge score was significantly different between the two groups (p < 0.001). The

intervention group achieved a higher knowledge score, with an average of 10.6 (95%

CI: 10.2 – 10.9). The control group also improved knowledge, averaging 9.0 (95%

CI: 8.6 – 9.4). The knowledge score was seen to change over time in both groups

(main effect of time was significant at p < 0.001), and the intervention group had a

larger improvement of knowledge score. On average, participants in the intervention

group had a 1.6 point (95% CI: 1.0 – 2.1) significantly higher knowledge score than

those in the control group. Table 5.21 presents the knowledge scores of two groups.

Table 5.21 Pairwise comparison of knowledge between two groups

Allocation N Mean 95% CI Mean difference

95% CI P

Control 70 9.0 [8.6, 9.4] 1.6 [1.0, 2.1] < 0.001

Intervention 70 10.6 [10.2, 10.9]

Note. CI: confidence interval


5.4.7 Effects of the self-management program on HF self-care

The similar mixed models examining changes of self-care scores over three time

points included group allocation, time, and group-time interaction. Wards of

participants were considered as a random effect in the models.

Participants who received the self-management program increased self-care

maintenance over time and had significantly higher self-care scores than those in the

control group (p <0.001). The intervention group achieved a maintenance score with

an average of 66.9 (95% CI: 64.5-69.3). The control group obtained a score

averaging 56.6 (95% CI: 54.1-59.0). At end-point intervention, participants improved

an average of a 10.6 point score increase (95% CI: 4.5-16.7, p < 0.001) compared to

that at baseline. The control group did not improve after one month (p= 0.57);

however, an improvement was seen at end-point averaging 5.0 (95% CI: 0.7-9.4, p=

0.02). The average score difference between the two groups was 10.3 (95% CI: 6.8-

13.7), which was significant at p < 0.001.

The intervention group had improved self-care management, while that of the control

group decreased after one month. The average difference between the two groups

was 6.7 (95% CI: 0.9-12.3, p = 0.02). The intervention group achieved a

management score with an average of 63.7 (95% CI: 59.6 – 67.8). The control group

obtained a score averaging 57.0 (95% CI: 53.0 – 61.0). At end-point, intervention

participants improved an average of 6.1 points (95% CI: -4.5-16.6, p= 0.25)

compared to baseline. The control group significantly decreased self-care

management scores after one month (p = 0.007).

Both groups had an increased mean score in self-care confidence; however, the

improvement was not significant. The intervention group achieved a maintenance


score with an average of 57.5 (95% CI: 54.4-60.6). The control group obtained a

score averaging 46.5 (95% CI: 43.4-49.7). The mean difference in confidence score

between the two groups was 10.9 (95% CI: 6.5-15.4, p <0.001), in comparison to the

mean difference at baseline (10.2 point). Self-care confidence score at the end-point

did not differ significantly to those measured at baseline in both groups (p = 0.09).

Table 5.22 presents the self-care scores of the two groups.

Table 5.22 Pairwise comparison of self-care between two groups

Outcome Group N Mean

95% CI

Mean difference

95 % CI P

Self-care

Maintenance

Control 70 56.6 [54.1 – 59.0] 10.3 [ 6.8 – 13.7] < 0.001

Intervention 70 66.9 [64.5 – 69.3]

Self-care

Management

Control 50 57.0 [53.0 – 61.0] 6.7 [0.9 – 12.3] 0.02

Intervention 50 63.7 [ 59.6 – 67.8]

Self-care

Confidence

Control 70 46.5 [43.4 – 49.7] 10.9 [ 6.5 – 15.4] < 0.001

Intervention 70 57.5 [54.4 – 60.6]

5.4.8 Effect of the self-management program on hospital readmission or death

Participants were asked to record each occasion of, and associated reasons for, each

hospital readmission. Cumulative numbers of hospital readmissions were collected at

one and three months after the commencement of the intervention. Any death case

was recorded as an outcome event. Previous hospital readmissions reported by

people who were then lost to follow up or death were also analysed. There were

participants who were lost to follow-up at two data collection occasions and their

data of hospital readmissions or deaths remained unknown. The number of hospital

readmissions/deaths in the two groups was analysed using two assumptions: 1) all

lost to follow up participants had no events of readmission or death; 2) all lost to

follow up participants had at least one cardiac-cause event of readmission or death.


Assumption 1: All lost to follow up people had no events of readmission or deaths

At one month after commencement of intervention, eight people (11.4%) in the

intervention group and 15 people (21.4%) in the control group either had at least one

all-cause hospital readmission or had died (RR =0.53, 95% CI [0.24 – 1.17], p =

0.12). There was a 10% reduction of readmission or death rate in the intervention

group. There were four and 11 all-cause readmissions in the intervention and control

groups, respectively. The number of cardiac-cause readmissions was three

(intervention) and seven (control). In the intervention group, four people died (5.7%)

compared with five in the control group (7.1%) (RR = 0.8, 95% CI [0.22 – 2.85], p =

0.73).

At three months, there were 29 people in the intervention (41.4%) and 24 people in

the control group (34.3%) who either had at least one all-cause hospital readmission

or who had died (RR =1.2, 95% CI [0.78-1.85], p = 0.87). The number of all-cause

readmissions in the intervention and control groups was 28 and 26, respectively. The

number of cardiac-cause readmissions was 19 in the intervention and 20 in the

control group. Seven people died in the intervention (10%) compared to nine deaths

in the control (12.8%) (RR=0.7, 95% CI [0.31 -0.97], p = 0.59).

Assumption 2: Each lost to follow up person had at least one cardiac-cause

readmission or death

Missing data were replaced by “having at least one cardiac-related

readmission/death”. At one month, 29 people (41.4%) in the intervention group and

34 people (48.6%) in the control group had at least one all-cause hospital

readmission, or died (RR =0.85, 95% CI [0.59 – 1.23], p = 0.39). There was a 7.2%

reduction of all-cause readmission or death rates in the intervention group. There

were 29 and 35 all-cause readmissions in the intervention and control group,


respectively. Cardiac-cause readmissions/deaths were 28 (intervention) and 31

(control), respectively.

At three months post discharge, 34 people (48.6%) in the intervention group and 32

people (47.1%) in the control group had at least one hospital readmission or had died

(RR = 1.1, 95% CI [0.75 -1.51], p = 0.73). There were 40 and 43 all-cause

readmissions in the intervention and control group, respectively. Cardiac-cause

readmissions/deaths were 31 (intervention) and 37 (control), respectively. Table 5.23

presents the number of hospital readmissions or deaths in the two groups at two time

points of data collection.

In summary, if all lost to follow-up participants had no readmission or death, there

was a 10% reduction in the all-cause readmission or death rate in the intervention

group after one month. If they had experienced at least one event, there was a 7%

reduction in the all-cause readmission or death rates. There was very little difference

in number of all-cause and cardiac-cause hospital readmissions between the two

groups after three months in either assumption (see Table 5.23).


Table 5.23 Hospital readmissions or deaths at two follow-up occasions

Note. +Number of hospital readmissions from those who were dead, or unable to be contacted were also counted.

++There were participants readmitted on more than one

occasion. Each event was a hospital readmission or death.

Time Hospital readmission +

Assumption 1: No event in each lost-to-

follow-up participant

Assumption 2: At least one event in each lost-to

follow-up participant

One

month

People readmitted or died

N = 8 (intervention) vs 15 (control)

RR = 0.53, 95% CI [0.24, 1.17], p =0.12; 10%

reduction


RR = 0.85, 95% CI [0.59, 1.23], p =0.39; 7.2 %

reduction

Number of all-cause readmission

N = 4 (intervention) vs 11 (control)++

N = 29 (intervention) vs 35 (control)++

Number of cardiac-cause readmission N=3 (intervention) vs 7 (control) N = 28 (intervention) vs 31 (control)

Three

months

People readmitted or died


RR = 1.2, 95% CI [0.78, 1.85], p = 0.87; 7.1%

increase


RR = 1.1, 95% CI [0.75, 1.51], p = 0.73; 1.5%

increase

Number of all-cause readmission

N = 28 (intervention)++

vs 26 (control)++


vs 43 (control)++

Number of cardiac-cause readmission N =19 (intervention)++

vs 20 (control)++


vs 37 (control)++


5.5 CHAPTER SUMMARY

Chapter 5 presented the results of three study phases. Phase One results indicated the

training workshop on HF self-management and the teach-back method improved

nurses’ knowledge of HF. The use of the teach-back method in teaching self-care

was supported by nurses as a method to deliver health education. After a rigorous

translation process, the Vietnamese SCHFI demonstrated satisfactory psychometric

properties for measuring self-care in people with heart failure in Vietnam. The

average self-care scores of a sampled Vietnamese population with heart failure were

below the cut-point of self-care adequacy. Cronbach’s alpha coefficients for three

subscales of the Vietnamese SCHFI were 0.47, 0.57, and 0.82, which were

comparable to those obtained in the original SCHFI validation testing. A model with

three V.SCHFI components (self-care maintenance, management, and confidence)

goodness-of-fit indices were Chi-square = 337.9, P < 0.001, CFI = 0.7, RMSEA =

0.08. Dimensionality exists in each subscale, and that needs further examination. The

cRCT indicated that the self-management educational program significantly

improved knowledge (p<0.001), self-care maintenance (p<0.001), and self-care

management (p= 0.02) for participants with heart failure. Effects in improving self-

care confidence and reducing hospital readmissions, however, were not significant

and require further investigation. This study was the very first to implement self-

management education to both cardiac nurses and patients in Vietnam. The study

results might inform changes in the practices of nurses in health education and create

opportunities for people with HF to receive self-management educational support.

The study results are discussed in the next chapter.

Chapter 6: Discussion 147

Chapter 6: Discussion

Chapter 5 presented the results of the three phases of this study. The results are

discussed in this chapter. The entire study was underpinned by two components of

the Chronic Care Model and principles of adult learning. A feasibility study of HF

self-management (Phase One) and the translation of a self-care instrument (Phase

Two) were conducted to prepare for the implementation of a self-management

educational program (Phase Three). The main purpose of Phase Three was to

examine how an intervention teaching self-management to people with HF could

change their HF knowledge and self-care behaviours, and whether the intervention

could assist with reducing hospital readmissions for those who received it. This

chapter first discusses how the results of this study fit with the two proposed

theoretical frameworks. The key results in each study phase are then discussed and

compared to the relevant findings in the literature. Discussions in this chapter form

the foundation for proposing implications and conclusions in the next chapter.

6.1 THEORETICAL FRAMEWORK

The Chronic Care Model and principles of adult learning have guided this study. The

Chronic Care Model (CCM) suggests improvements in chronic care by making

changes in six core elements: the health system, clinical information, decision

support, delivery system, self-management support, community resources, and

policies (Pearson et al., 2005). All CCM elements interact to achieve the final goals

of the model, which are an informed health care team and activated patients. The

main study (Phase Three) involved a self-management intervention that was

underpinned by two CCM elements: decision support and self-management support.

148 Chapter 6: Discussion

As this study involved educational activities structured for nurses and adult patients,

the principles of adult learning were integrated to guide the delivery of education.

The interventions, guided by two CCM elements, decision support and self-

management support for people with heart failure, have previously been reported in

the literature. Common interventions, including patient education, telephone follow-

up (self-management support), and booklets (decision support) were found in a

recent systematic review of the CCM in heart failure (Drewes et al., 2012). This

current study embedded these two components into the intervention to deliver self-

management educational support to people with heart failure. The study

demonstrated improved heart failure knowledge, self-care, and reduced hospital

readmissions (although this was not statistically significant) among individuals who

received the intervention. These results were consistent with those of other studies

adopting decision support and self-management support in heart failure (Atienza et

al., 2004; Baker et al., 2005; DeBusk et al., 2004; Tsuyuki et al., 2004). This study

provided only one nurse-led single patient’s educational session at discharge,

whereas other form of support have been extended to the intervention groups, such as

24-hour telephone support with heart failure clinical team (Atienza et al, 2004) or on-

going community support (Tsuyuki et al., 2004). By using the teach-back method to

educate participants, mutual communication is facilitated between the nurses and

participants during the sequence of the ask-tell-ask process. Educational sessions for

nurses (Phase One) and patients (Phase Three) were targeted to achieve the two final

goals of the Chronic Care Model. The results of this study demonstrated consistency

with the CCM. Making changes in health care on the basis of decision support and

self-management support proved to be feasible in the Vietnamese health care

context. In comparison, other studies that targeted multiple elements of, or the entire


CCM, in improving delivery of health care have obtained greater improvements in

health care outcomes of chronic diseases. Whether or not other elements of CCM are

appropriate to guide health care changes in the Vietnamese context requires further

exploration.

Professional development training for nurses is essential to keep them updated

regarding new knowledge relevant to nursing practice. Yet, many nurse educators

have limited exposure to the principles of adult learning, which affects the nurses’

learning outcomes (Curran, 2014). Whilst professional development education for

nurses mostly employs teacher-centred styles; this study employed the literature-

supported teaching principles of the Adult Learning Theory. Group discussion and

role play demonstrations in this current study were used to improve nurses’

motivation and experience of how to use the teach-back method with patients. These

learning activities have previously been successfully employed in other training

opportunities for nurses (Dosch, 2013; Mahramus et al., 2014). Currently, delivery of

health education in Vietnam is predominantly educator-centred, meaning that

regardless of the health discipline educating patients, the physician, nurse, or

pharmacist decides what information is required by patients. Differences in the

learning needs of each individual patient are given little attention. By acknowledging

how an adult learns, this study has adopted a more learner-centred teaching strategy

for use by nurses with patients, and their improved learning outcomes have

demonstrated the appropriateness of this teaching approach.

The study results proved that the intervention guided by two CCM elements has

improved the heart failure knowledge and self-care of this sample. This indicates that

the decision support and self-management support elements of CCM are practical to

guide health care improvements in Vietnam. Yet the implication of the adoption of


all the CCM elements in a Vietnamese context remains unknown. The employment

of embedded adult learning principles in the professional development education of

nurses, and in teaching patients, demonstrated positive learning outcomes. Nurse

educators should therefore increase the use of adult learning approaches in teaching

self-management of chronic disease to patients.

6.2 PHASE ONE: FEASIBILITY OF TRAINING HF SELF-MANAGEMENT FOR

CARDIAC NURSES

Phase One was a pilot training workshop aimed at teaching cardiac nurses two

content areas: heart failure self-management and the use of the teach-back method to

teach patients. The workshop involved assessment of nurses’ knowledge of HF as the

learning outcome and their evaluation of the training contents, which would be used

for further refinement of this workshop.

Nurses are acknowledged to be in a good position to provide self-management

educational support to patients. This study assisted nurses with their understanding of

HF self-management, and introduced them to an effective teaching method to

communicate with people. The results found that nurses had knowledge deficits at

baseline about restriction in daily fluid intake (36.8% wrong) and cold/flu as factors

that cause an exacerbation of HF symptoms (84.2% wrong). Mahramus et al. (2014)

assessed 150 nurses’ knowledge of HF finding that only 6.0% passed the pre-test and

41.3% passed the post-test (passing score ≥ 85% correct). There were significant

knowledge deficits of those nurses related to signs and symptoms of HF

exacerbations, fluid and blood pressure assessments, dietary and medication

restrictions, and symptom management at home and when patients need to contact

their health care providers (Mahramus et al., 2014). Other studies measuring nurses’

HF knowledge also identified similar knowledge deficits (Delaney, Apostolidis,


Lachapelle, & Fortinsky, 2011; Fowler, 2012; Hart, Spiva, & Kimble, 2011). This

indicates that even nurses working in cardiac wards need to learn more about general

HF knowledge. The HF self-management content taught in the workshop has filled

these knowledge gaps by including explanations of HF symptoms, self-management

of those symptoms, and detailed information of monitoring fluid intake, exercise, and

salt restriction. The post-test answers demonstrated that incorrect answers largely

decreased among the cardiac nurses, and all nurses obtained an adequate level of HF

knowledge (≥ 11 score) upon the completion of the workshop. This indicated that

such a brief educational workshop could benefit nurses’ HF knowledge, and that it

will assist them in educating patients about HF self-care. However, the post-test was

conducted immediately after the training, thus, increased scores by participants might

reflect their familiarity with the test questions rather than deep learning about HF

self-management. Therefore, an assessment of nurses’ retention of knowledge over a

longer follow-up duration is recommended to eliminate this assumption.

There are currently gaps in nursing practice regarding teaching self-management to

people with chronic diseases, and HF in particular, in Vietnamese health care

settings. The health care system is generally burdened by acute care services; hence,

nurses’ tasks are majorly focused on technical skills. It is time for nurses to improve

their nursing practice in HF care. While self-management is presently emerging as a

key solution in chronic health care, this training workshop was the first to introduce

nurses in Vietnam to heart failure self-management and to provide them with

important messages to be shared with HF people. Previous studies have found that

training nurses about chronic disease self-management can enhance nurses’

knowledge at course completion and the improvements can be sustained (Mahramus

et al., 2014; Walters et al., 2012). Further studies are necessary to examine whether


these nurses will be willing to teach HF self-management in their routine practice

and how that can improve their patients’ self-care ability.

The teach-back method has been increasingly introduced as a part of professional

development training for multidisciplinary health care staff across other cultures

(Dosch, 2013; Hahn et al., 2010; Mahramus et al., 2014). This study was the first to

develop a brief training session on the teach-back method in the Vietnamese

language and to make it accessible for Vietnamese nurses. This contributes to

nursing practice improvement, as the teach-back method is increasingly endorsed as

one of the top safe practices (National Quality Forum, 2010). By asking patients

“Could you please tell me what you need to do to avoid salty food” rather than “do

you remember what I said”, this simple method indicates how well an educator

delivers information to a patient and how well the patient understands the

information from the conversation. The sequence of teaching back increases the

quality of health education practice and benefits both nurses and patients. The teach-

back method principles are simple, but nurses need to practice them. Mahramus et

al’s study has revealed 43.1% of participants required remediation in teach-back

performance after the first demonstration (Mahramus et al., 2014). The short

designated time for this pilot study did not enable the assessment of the teach-back

method demonstration among individual participants. Further follow-up is necessary

to monitor how these nurses will use the teach-back method in their practice. As

presented earlier in this thesis, a number of studies using the teach-back method to

educate patients have yielded positive outcomes in heart failure, diabetes and

COPD/asthma. As nurses providing education to patients (Negarandeh et al., 2013;

Krumholz et al., 2002;White et al., 2013), training nurses to use teach-back not only

improves their practice of health education, but also benefits patients’ health care.


In summary, this study was the first pilot in Vietnam to teach nurses about heart

failure self-management and a method to educate patients. Nurses’ acceptance of

these contents indicates the potential of extending this training workshop to more

nurses, and improves nursing professional development education in Vietnam.

6.3 PHASE TWO: PSYCHOMETRIC PROPERTIES OF THE VIETNAMESE VERSION OF

THE SELF-CARE FOR HEART FAILURE INDEX

Phase Two of this PhD study involved translating and validating the original SCHFI

instrument into the Vietnamese language (V.SCHFI). This process included a

rigorous forward and backward translation, followed by assessing the CVIs, internal

consistency, and construct validity of the V.SCHFI. The testing indicated satisfactory

content validity and evidence of reliability and construct validity of the V.SCHFI.

The original SCHFI had been previously translated into a variety of other languages,

enabling examination of heart failure self-care behaviours and comparing them

among various cultures (Ávila et al., 2013; Kang et al., 2015; Siabani et al., 2014;

Vellone, Riegel, Cocchieri et al., 2013).

This study was the first to translate this instrument into Vietnamese and rigorously

adhere to the methodologies in Sousa’s guidelines (Sousa & Rojjanasrirat, 2011).

There was another instrument, the nine-item European Heart Failure Self-care

Behaviour, measuring heart failure self-care behaviour, which was available in

Vietnamese (N. H. Nguyen et al., 2011). However, the SCHFI was selected to be

used in this current study for two reasons. First the SCHFI is an internationally

recognised instrument, and its availability in the Vietnamese language will enable

comparison of self-care behaviours among Vietnamese people with HF to other

populations. Secondly, the SCHFI is a theory-based questionnaire that integrates

confidence in performing HF self-management skills. Confidence is known to be a


factor mediating behaviours regarding adhering and maintaining healthy behaviours

toward heart failure (Cene et al., 2013), hence, strategies toward confidence are

essential in self-care. The SCHFI confidence subscale assists in evaluating the

effectiveness of such strategies.

The results indicated that the V.SCHFI was mostly linguistically equivalent to the

original, and items were culturally relevant to people with HF from a Vietnamese

speaking background. A few words were changed or added, as well as examples of

specific activities in certain items of the Vietnamese version to improve the

comprehension of target population. Such wording adaptations also occurred

previously during the process of translating the SCHFI into other languages (Ávila et

al., 2013; Siabani et al., 2014; Vellone, Riegel, Cocchieri et al., 2013). The SCHFI

items reflect that there are differences in practices in heart failure care between

Vietnamese hospitals and Western health care systems (i.e., flu-shot indication, or

self-adjustment of water pills). Item 3 regarding the behaviour to prevent HF

symptoms worsening (for example, getting flu shots or avoiding ill people) was

found to be problematic in terms of cultural relevance. Influenza vaccination is not a

routine indication for people with HF in Vietnam, due to cost and availability. In

addition, visiting a person when he or she is ill is a Vietnamese custom or

expectation. Hence, “getting flu shots” was deleted from the item 3. This fact also

flags that flu vaccinations should be recommended for people with heart failure, and

that requires the attention of preventative health policies. It also highlights that when

linguistic and technical equivalence are apparently obtained in translating the study

instruments, researchers still need to make a careful consideration of cultural

relevance when selecting a study instrument (Symon et al., 2013).


The V.SCHFI testing initially showed an excellent scale-level CVI (0.96). The CVIs

of the SCHFI subscales were not frequently reported during validation testing of this

instrument in other languages. Only the Chinese SCHFI testing reported a CVI of

0.94 for the whole SCHFI (Kang et al., 2015). Another study reported the content

validity index of 0.89 for a previous version of the SCHFI (v4) (Yu, Lee, Thompson,

Woo, & Leung, 2010). The average scores in the three subscales of the V.SCHFI

were lower than the scores obtained in the original USA sample and below the

defined cut-off for self-care adequacy (Riegel et al., 2009). Low levels of self-care

among adults with HF in Vietnam were reported in a previous study (measured using

European Heart Failure Self-care Behaviour Scale) (N. H. Nguyen et al., 2011). A

study comparing HF self-care scores from studies in 15 countries, found low levels

of adherence to self-care activities among those with HF, regardless of culture or

country (Jaarsma et al., 2013). In general, self-care in HF is challenging due to

barriers such as unstable HF symptoms, the complexity of the self-care process,

insufficient HF knowledge, and high rates of comorbidities (Siabani, Leeder &

Davidson, 2013). Self-care in individuals with HF in Vietnam is more problematic

due to the lower socioeconomic status of the Vietnam population, and the lack of

access to routine health care. Moreover, health education practice in Vietnamese

hospitals is generally not targeted to assist self-care in individuals with HF.

While the self-care maintenance and management scores in the Vietnamese sample

are comparable to those obtained from other populations (Ávila et al., 2013; Siabani

et al., 2014), the confidence score was lower than those reported in other population

(Ávila et al., 2013; Kang et al., 2015; Siabani et al., 2014; Vellone, Riegel, Cocchieri

et al., 2013). This result could be explained as being due to Vietnamese patients often

relying on their doctors’ advice to choose good HF behaviours, and not being


confident to independently care for themselves. Low self-care confidence might also

be associated with lower levels of education and socioeconomic status in this sample,

as half of the participants had an education level of high school or below.

Overall, the study provided some evidence of acceptable internal consistency and

construct validity of the V.SCHFI. The Cronbach’s alpha values of the self-care

maintenance and management subscales (0.47 and 0.57 respectively) were slightly

lower than the psychometric properties obtained in the original study (Riegel et al.,

2009) and previous studies testing SCHFI in other languages (Ávila et al., 2013;

Siabani et al., 2014). Low reliability in two subscales of the V.SCHFI suggests that

items in these subscales might not reflect typical self-care behaviours among

Vietnamese people, which may be different to those of Western cultures. For

instance, choosing low salt items when eating out (item 9) is challenging in the

Vietnamese culture where meals are typically shared with everyone. Self-adjusting

(increasing) the diuretic dose (item 14) is an active behaviour; however, Vietnamese

patients would not be told to do this, and would probably, given the cost of

medications, be reluctant to do so. Lastly, item 15, “call doctors or nurses for

guidance” is not a common practice, as most Vietnamese public hospitals do not

have a hotline or phone support to assist patients at home. The differences in culture

and health care delivery in Vietnam may explain the comparatively low scores and

reliability coefficients in these self-care maintenance and management subscales.

This highlights that researchers need to consider cultural relevance when selecting a

study instrument, although linguistic and technical equivalence can be obtained

during the translation process (Symon, Wu, Nagpal & et al., 2013).

Further evidence of the V.SCHFI validity was demonstrated by confirmatory factor

analysis (CFA). The original single three-factor model did not fit with the this


sample of Vietnamese HF patients, although this result was consistent with other

validation testing of the SCHFI in other languages (Ávila et al., 2013; Riegel et al.,

2009; Siabani et al., 2014). Barbaranelli et al. (2014) demonstrated that

multidimensionality exists in three SCHFI subscales. The CFA model of self-care

confidence in the Vietnamese sample was an excellent fit, and that supported

Barbaranelli et al’s findings. The sample was too small to successfully perform CFA

for self-care maintenance and self-care management subscales, as the sample size of

this psychometric test was powered for the trial. The result proposes a CFA testing

the V.SCHFI in a sufficient sample size (being powered for the psychometric testing)

to replicate the factorial structure of three SCHFI subscales, or to find a different

dimensionality of V.SCHFI, which reflects self-care in HF among Vietnamese

people.

The psychometric testing of the V.SCHFI included participants with a wide range of

age, socioeconomic status, education, and stage of HF. The sample was likely to be

representative of the real target population, however, the sample size was not

sufficient to perform CFA. As the reliability coefficients of the self-care maintenance

and management were lower than the preferred level (< 0.7), and a poor model fit

was detected by CFA, full psychometric testing of this instrument (i.e., test-retest,

convergent validity, EFA) is necessary to better understand the psychometric

properties of this instrument among Vietnamese speaking people with heart failure.

In summary, the validation process of the V.SCHFI provided evidence of content

validity, internal consistency, which supported further use of this instrument. Health

care providers have a tool to assess which self-care behaviours patients are

performing and which behaviours are absent, in order to adjust self-care strategies to

suit individual patients.


6.4 PHASE THREE: THE EFFECTIVENESS OF A HF SELF-MANAGEMENT PROGRAM

This phase was the main study to examine how a program teaching self-management

to people with HF can improve their knowledge and self-care. The teach-back

method was used to support intervention delivery and promote retention through

follow-up phone calls to participants. Study results revealing initial improvements on

HF knowledge and self-care were found in this sample. First, participants’ profiles

should be compared to those in other studies. The associations between demographic

characteristics and knowledge and self-care in heart failure will also be discussed.

The effects of the intervention on targeted outcomes will be explained and compared

to those in previous literature.

This study sample included 140 participants equally divided by gender. The

proportion of females was similar to that of males, and was higher than the female

proportion in other samples. This can be explained by the equal distribution of beds

for two genders in each participating ward. The average age of participants was 54

years old, indicating this sample was younger than the participants in other study

populations with HF (Davis et al., 2012; DeWalt et al., 2006; Krumholz et al., 2002;

White et al., 2013). Forty-six of participants had been diagnosed with HF for less

than 1 year; therefore, assisting them to engage in life-style changes can improve

their life expectancy. Well over half of the participants had not attended schooling or

completed less than secondary schooling. More than half of the participants were

farmers and retired people, meaning that they experienced financial hardship. These

characteristics reflected that this sample consisted of people with low education

levels and low socioeconomic status. Most people were living with several co-

morbidities; the most common co-existing conditions were hypertension, kidney

failure, and diabetes. Self-care management scores were slightly higher than other


subscales at baseline; however, the mean score was lower than those reported in

studies in other countries (Kang et al., 2015; Siabani et al., 2014; Vellone, Riegel,

Cocchieri et al., 2013) and below the cut-off point of self-care adequacy (Riegel et

al., 2009).

Self-management programs are often designed to assist disadvantaged participants.

The participants in this study were characterised as such by their lower education

levels and socioeconomic status, were newly diagnosed, and had comorbidities.

Improved health care for patients will assist them to live longer, healthier lives

during their disease trajectory coping with HF.

The results revealed there were differences in HF knowledge and self-care among

people with different education levels, occupations, marital statuses, and gender.

People who completed graduate training had higher HF knowledge than people with

high school or lower education. There has generally been a consistency found in

other studies that lower educational level is associated with lower knowledge in

people with heart failure (Bonin et al., 2014; Davis et al., 2012). This demonstrated

that people with lower educational backgrounds are likely to have less understanding

of their disease, and that they require more attention from health care providers in

their health education.

It was interesting to observe that level of self-care maintenance among this sample

was significantly different between people with different occupations but did not

differ by education levels. Those working in unskilled sectors had a lower self-care

maintenance score than those who were working in professional jobs. This may be

due to the people working in professional sectors often having better educational

backgrounds, higher incomes, and more regular working schedules than people who

have other jobs, hence, they are in a better position to make and maintain choices of


healthy lifestyles. There is limited investigation regarding the linkages between a

person’s work and their self-care performance. A study indicated that the

requirement of physical work was seen as a factor creating difficulty in self-care for

people with HF compared with sedentary jobs (Dickson, McCauley, & Riegel, 2008).

Especially for agricultural workers, as for the majority of participants in this study

sample, irregular working time and place contributed to poor adherence to

medication and dietary advice. Integrating self-care at work and modifying jobs to

facilitate self-care was noted as enabling effective work and HF self-care (Dickson et

al., 2008; Europe & Tyni-Lenne, 2004).

Married people were seen to perform self-care management better than those who

were single or divorced. Physical and psychological support from spouses was an

important part in assisting better health care in HF. A systematic review found that

caregivers (mostly spouses) most frequently facilitated HF self-care in medication

management, sodium restrictions, and symptoms recognition through daily reminders

and support (Strachan, Currie, Harkness, Spaling, & Clark, 2014). This indicated

that involvement of patients’ spouses or other caregivers in self-management

strategies would benefit HF self-care.

Males and people with higher education had greater confidence in self-care than

females and those with lower school education. Other studies found little or no

difference between males and females in HF self-care confidence using the SCHFI

(Cocchieri et al., 2015; Heo, Moser, Lennie, Riegel, & Chung, 2008; Lee et al.,

2009). Therefore, the significant difference between two genders in self-care

confidence in this Vietnamese sample indicates that it is culturally different. Males

are often more socially recognised and receive more care support in the Vietnamese

culture; hence, they felt more confidence in self-care. Understanding which personal


factors are significantly associated with HF knowledge and self-care is useful for

Vietnamese health care providers to target their self-management support to more

disadvantaged groups of people, including those with lower educational background,

those with unskilled jobs, who are single, or living alone, and females.

One primary outcome of interest in this cRCT was the knowledge of heart failure

measured by the Dutch HF Knowledge Scale. The study found increased knowledge

in both groups, although significantly larger knowledge improvements were seen in

participants who received the self-management education program. Participants in

the intervention group achieved 1.6 points higher at the end-point. The control group

had also increased their knowledge by using the heart failure booklets. The

difference between the intervention and control group, however, proved that teaching

people with the teach-back method was superior to simply providing written

materials for them.

This program succeeded in improving participants’ knowledge for several reasons.

First the self-management strategies were evidence-based from previous rigorously

implemented studies. The use of teaching booklets had been an essential component

in many other interventions for heart failure (Linne & Liedholm, 2006; Riegel &

Carlson, 2004; Shively et al., 2005; Sisk et al., 2006; Smith et al., 2005; Strömberg et

al., 2003; Tsuyuki et al., 2004). The HF booklet in this study was adapted from the

“Living everyday with my heart failure” booklet with copyright permission of the

Australian Heart Foundation. The booklet provided essential knowledge about heart

failure for people at early stages of this syndrome, including diagnosis and treatment,

explanations of common symptoms, how to manage symptoms, fluid and salt

reduction, regular exercise, managing daily weight, get-help signs, and medication

monitoring. These HF educational topics were derived from a large systematic


review of 35 selected trials about self-management programs in heart failure, and of

them, the most common topics were symptom monitoring, daily measurement of

weight, and sodium restriction (Boren et al., 2009). However, many people face

difficulties with reading written material, especially older adults with visual or

cognitive impairments, and those who have only completed lower levels of school

education. By adopting the technique of teach-back, participants had a chance to

reflect back with the educator on what they understood, or to decide whether they

needed further explanations of any unclear information. There was robust evidence

for using the teach-back method in improved knowledge in heart failure and other

chronic diseases.

Health literacy refers to an individual’s capacity to obtain, process and understand

basic health information to make appropriate health decisions (Kickbusch, 2001).

Lower heath literacy is especially prevalent in aged people, those with lower

socioeconomic status and lower educational level, as reported in a review of 85

studies with 31,129 participants (Paasche‐Orlow, Parker, Gazmararian, Nielsen‐

Bohlman, & Rudd, 2005). The teach-back method has been endorsed as a tool to

improve understating (i.e. knowledge) in people with low health literacy (Kountz,

2009). Previous studies have found that people with lower health literacy skills

improve their knowledge of HF following an intervention incorporating the teach-

back method (DeWalt et al., 2006; Kiser et al., 2012). Health literacy was not

measured in this study; however, most of the participants had completed less than

high school level of education, and as such are more likely to have insufficient health

literacy skills. This study’s intervention included not only the teach-back method, it

also provided a booklet specifically suited for lower reading skills. Participants also

received diaries, which were designed to remind them about the use of medications,


recording symptoms and following a self-care plan. It is recommended that further

studies supporting HF self-care behaviours ought to measure health literacy as an

outcome.

This study was one of only a few studies that embedded the principles of adult

learning in teaching self-management to adult participants (Boyde et al., 2013; Press

et al., 2012). Adults must feel a need for the information being taught; therefore, the

educator asked each participant for their experienced symptoms and then linked them

to the relevant contents in the HF booklets. The participant’s own experiences in

recognising and managing their HF symptoms were discussed and reinforced. The

educator instructed participants to adhere to a low salt diet by reading food labels,

avoiding common salty foods, and preparing a low salt portion when they routinely

shared meals with other family members. Participants were more motivated to learn

knowing that they would be able to maintain their healthy conditions and potentially

reduce avoidable hospital readmissions by adhering to suggested behavioural

changes. Due to the time limitation, the educational sessions were not able to be

individualised to meet the learning needs of each participant. Newly diagnosed

people may have needed more intensive learning about new self-management

behaviours, whereas experienced individuals, or those with co-morbidities might

have been be interested in different educational topics. The results indicated that all

participants in both groups achieved low HF knowledge and no one had an adequate

knowledge (≥ 11 score) at baseline. It can be assumed, therefore, that the topics

covered in the intervention suited the gap of information for all participants. Future

studies that address the specific learning needs of participants need to be tailored to

maximise the effects of self-management education.


Although all participants achieved improved and sustained HF knowledge at the end-

point, there are several strategies to be considered to enhance delivery of such self-

management programs in the future. This self-management support program was

literature-supported; however, it only consisted of a simplified, one-on-one

individual session with a single follow-up telephone call. Evidence regarding the

optimal dose, length, and frequency of educational support is yet to be determined;

however, improved outcomes have generally been achieved in studies attempting to

conduct multiple educational sessions (Swavely et al., 2013) and tele-management

(DeWalt et al., 2006; Krumholz et al., 2002). The option of clinical pharmacists and

dieticians assisting with delivery of HF self-management should also be considered,

for example, teaching diuretic self-adjustment or dietary modification for those with

comorbid diabetes (DeWalt et al., 2006; Swavely et al., 2013). In addition,

individualising self-management strategies to assist people to effectively translate

their obtained knowledge into their routine healthy behaviours should be included.

This study contributes to the current body of literature regarding the use of the teach-

back method in teaching self-management to HF people. This self-management

education option is an effective and feasible choice that can be delivered in

Vietnamese health care settings. This study’s results show the potential for nurses to

improve the knowledge of HF people, regardless of their educational background, by

using a simplified self-management program with the teach-back method. This self-

management program, including the teach-back method to explain a self-care

booklet, can be standardised to be a brief health education session routinely delivered

to people with HF.

The cRCT results indicated there were significant differences in self-care

maintenance and self-care management scores, but not self-care confidence in the


two study groups. Three self-care dimension scores at baseline in the two groups

were below the cut-off points of self-care adequacy (≥ 70), which indicated that self-

care was inadequate among these participants. The intervention group did show

adequate self-care in self-care maintenance and management at the end-point. The

improved knowledge of HF was translated into changing their self-care. The self-

care management was not significantly increased after three months; however, it was

sustained in the intervention group, while those in the control group decreased.

There are several explanations for improved self-care maintenance and management

in this trial. Self-care maintenance is a series of activities that employs healthy

behaviours to manage HF, and is an essential foundation of effective HF self-

management (Riegel, Lee, Dickson, & Medscape, 2011). These activities are

consequently more likely to be advised to participants in the early stages of diagnosis

and treatment. Therefore, people have partly integrated these activities into their

daily routines. This study provided additional detailed instructions on sodium and

fluid restriction, regular exercise, and adherence to medication to participants so that

they were able to make and maintain these healthy behaviours. The intervention

components were health education literature-supported to have positive improvement

in self-care for people with HF. The teaching contents were supported by a booklet,

which participants could take home for multiple reading opportunities. The teach-

back method was an important process to ensure patients correctly understood the

delivered messages, which was then promoted though telephone calls. Moreover, the

provision of diaries and weighing scales for participants encouraged them to adhere

to medication and to monitor their daily weight. Previous studies have shown their

success in improving the behaviour of daily weighing as one of key self-care skills in

heart failure (Caldwell et al., 2005; DeWalt et al., 2006).


The literature has addressed social support as a predictor of self-care maintenance

and management (Graven & Grant, 2014; Salyer, Schubert, & Chiaranai, 2012).

People who have social support from family members achieve better HF self-care,

especially in medication and dietary adherence (Sayers, Riegel, Pawlowski, Coyne,

& Samaha, 2008). This study involved family members in health education whenever

they were available, however, the study did not assess how social support impacts on

the performance of self-care in people. A study by Reigel et al. (2004) found sharing

information between patients and other trained patients improved self-care in people

who received peer mentoring support, and self-care confidence in those mentoring

the others (Riegel & Carlson, 2004). Peer support might be a promising option for

studies targeting self-care improvement. Further studies combining peer mentoring

from trained patients in conjunction with self-care education by health professionals

might introduce a practical model for self-care support to HF people.

Self-care management was sustained in the intervention but decreased in the control

group. The first reason may be due to the small numbers of people eligible for the

calculation of self-care management scores at two follow-up occasions; thereby

reducing the statistical power to detect minor changes in this variable. Second, self-

care management evaluated the active responses of people when their symptoms

deteriorated, e.g., take an extra water pill. However, this intervention was not

designed to provide comprehensive instructions to participants on how to adjust

water pills. While medical doctors in Vietnam have an integral role in deciding on

medication adjustment, they also provide very little education to patients. Salyer and

colleagues’ (2012) found that confidence is the best predictor of self-care

management. Self-care behaviours therefore may improve as a function of

confidence but not a function of increased knowledge, as proposed by Sousa et al.


(2005). Future interventions should therefore embed strategies aimed at enhancing

confidence in self-care to target improved HF self-care management. Self-care

improvements are more likely to be observed when interventions are conducted

outside hospitals. Participants often feel exhausted during their period of

hospitalisation and therefore educational support is preferred after discharge when

their conditions are more stable. This was supported by research on people followed

in a nurse-led HF clinic over one year who had significantly greater self-care

behaviours at three and 12 months compared to the control group (Strömberg et al.,

2003).

This study was the first to teach self-management to people with HF in Vietnam and

initial results in improved knowledge and self-care were supportive. This study has

not improved self-care confidence among people with heart failure, refinements of

the intervention are therefore required to involve confidence strategies as key

determinants for successful self-care among HF people.

This study found a trend in the reduction of hospital readmission or deaths in the

intervention group, although these figures did not differ significantly between the

two groups. The 30-day all-cause readmission rate for all participants in this study

(21.4%) was consistent with those reported in other studies, which ranged from 21-

23% (Davis et al., 2012; Hernandez et al., 2010; Ross et al., 2010). This current

study found a low 30-day cardiac-caused readmission rate (4.2%) in the intervention

group, which was similar to White et al.’s study (2013). The rate is much lower

compared to an average of approximately 20% of patients with HF who are

readmitted to hospital within 30 days of discharge (Bradley et al., 2013). The

reduction in the hospital readmission rate was also not observed at 30-day post

discharge in people receiving self-management education in previous studies (Davis


et al., 2012; White et al., 2013). A study highlighted that even people who correctly

answered the teach-back questions during hospitalisation or follow-up also did not

have lower 30-day hospital readmissions (White et al., 2013). These results are

consistent with a review of studies that reported no significant reduction of

readmitted people who received HF self-management programs (Ditewig et al.,

2010). This means that improved knowledge about managing symptoms and self-

care is not sufficient to prevent patients from being readmitted to hospitals. Only one

previous study reported a 40% reduction of 30-day cardiac-related hospital

readmission in the intervention group, which was significantly different to the

control group (Krumholz et al., 2002).

There were several reasons that might explain the non-remarkable reduction of

hospital readmissions or deaths in this study. First, a high proportion of people with

comorbidities was present in both groups of this sample. Braustein et al. (2003)

found that the presence of non-cardiac chronic disease increased the risk of

hospitalisations in heart failure. In addition to comorbidities, the frailty of this

sample was demonstrated by the majority of participants with HF categories III – IV

and 11.4% deaths occurring during the three months follow-up. Moreover,

readmitting to hospital is the only option for Vietnamese people with HF when their

symptoms worsen, because there is a lack of general practitioners, family doctors, or

hospital hotlines for help. There were hospitalisations that could have been

preventable if health counselling was available in a community setting. This study

only provided a follow-up phone call to each participant for the purpose of

reinforcing self-care messages, but was not able to provide further advice for treating

patients’ health conditions. There has been a call for more attention from hospital

policy makers in Vietnam to develop distance counselling, or home visits for


assisting post-discharge patients to prevent avoidable hospital readmissions. Multiple

attempts will be required to reduce hospitalisations in heart failure, including

improving the quality of pharmacological therapies, discharge education, and post-

discharge assistance (Herriman, 2007). The lack of success in reducing hospital

readmission in this study highlights the urgency of changing health services delivery,

i.e., distance counselling, in Vietnamese hospitals. In the Vietnamese context, a

patient’s decision to be readmitted to hospital or not is also influenced by a number

of personal factors, such as their dependence on caregivers, difficulty reaching the

hospital, and hospital cost burden. These factors need to be understood well to

explore solutions for reducing hospital readmissions caused by HF in addition to

self-management education efforts. It is also necessary to conduct exploratory studies

to examine the factors determining the decisions of people with heart failure to

readmit to hospitals.

6.5 CHAPTER SUMMARY

This chapter discussed the results found in three phases of this PhD study, and the

results encourage conducting HF self-management education in Vietnam. The pilot

study training for nurses indicated the benefits of teaching nurses about HF self-

management, and nurses’ acceptance of using the teach-back method in their practice

advocates for the extension of this teach-back training to more nurses. The

Vietnamese version of SCHFI had acceptable reliability and validity for being used

to measure self-care behaviours in heart failure. A full psychometric testing of the

V.SCHFI will be useful to assist an in-depth understanding of the instrument’s

psychometric properties. The self-management program in heart failure (Phase

Three) revealed significantly increased levels of knowledge and self-care among

those who received self-management educational support, although they did not


achieve improved confidence in self-care. The all-cause and cardiac-caused hospital

readmissions and deaths were shown to be lower in the intervention group, but the

figure did not differ significantly to the control group. The results in this current

study are consistent with those in the existing literature, and propose implications for

further studies, which are presented in the next chapter.

Chapter 7: Conclusions 171

Chapter 7: Conclusions

7.1 INTRODUCTION

Chapter 6 discussed the results of this study in comparison with existing relevant

literature. This chapter first reviews the strengths and the limitations of the entire

study. The chapter then proposes the implications of this study for nursing education

and practice, for health policies in Vietnam, and for future studies. The main

conclusions of the study are also presented.

7.2 STRENGTHS AND LIMITATIONS

This study has a number of strengths and limitations concerning the research design

and its contributions to health literature in Vietnam. Understanding these strengths

and limitations will assist in the development and implementation of future self-

management interventions for people with HF in Vietnam.

7.2.1 Strengths of the study

Firstly, this study was theory driven. The two components of the Chronic Care

Model (self-management support and decision support) underpinned educational

sessions for nurses and patients with HF. The teach-back method, which was

embedded in the principles of the Adult Learning Theory, provided a unique teaching

technique to assist the researcher to assess and improve the understanding of

participants regarding HF self-management.

Second, the literature about the teach-back method in previous studies was reviewed

systematically through a wide range of well-recognised databases. The systematic

review rigorously followed the Joanna Briggs Institute (JBI) methods of assessment

and review of quantitative studies. The systematic review yielded robust evidence in

172 Chapter 7: Conclusions

using the teach-back method to educate patients with heart failure, and that guided

the training workshop for nurses (Phase One) and the self-management intervention

for people with HF (Phase Three) (Dinh et al., 2016).

In addition, the study was the first to rigorously translate a widely used self-care

instrument (SCHFI) and to validate it in a Vietnamese population. The availability of

the SCHFI in Vietnamese enables health care providers or researchers to assess self-

care behaviours among Vietnamese-speaking people, and compare their scores with

other studies using the same instrument.

Next, the main study is a cluster randomised controlled trial, which is one of the

strongest research designs to evaluate effectiveness of an intervention. Cluster

randomisation was used to minimise the potential risk of contamination and detection

bias among participants. This was the first time a HF booklet and diary were

purposefully developed for teaching self-management to people with HF in Vietnam.

Using a trained nurse to deliver the individual education to participants indicates that

the self-management program is feasible to be delivered by nurses who are trained

appropriately about the program.

This study has an important significance to the practice of Vietnamese nurses and to

the health care of people with HF in Vietnam. This is the first study to teach nurses

about HF self-management, and introduce them to a new teaching method to improve

the quality of their health education to patients. The pilot study (Phase One)

indicated that teaching nurses HF self-management and the teach-back method was

feasible, and could be extended to more nurses as a form of professional

development training. This study also targeted the teaching of self-management to

patients with heart failure. While heart failure care in Vietnamese hospitals

particularly focuses on pharmacological treatments, teaching patients about self-


managing their symptoms, medication use, and changing their life-style appropriately

can assist them to prevent symptom exacerbation, and to live healthier and longer

lives. The self-management program can be standardised to be a brief discharge

education program for people with heart failure, which will improve the health care

services in Vietnamese hospitals.

7.2.2 Limitations of the study

Despite a number of strengths, the study also has several limitations. First, the

sample of nurses in Phase One were those who volunteered to participate, hence,

they might be more knowledgeable than other nurses in Vietnam. In addition, the

Dutch Heart Failure Knowledge Scale was originally developed for patients, so it

might be relatively easy for cardiac nurses to score highly. The pre-test results of the

workshop, however, detected two cardiac nurses whose scores indicated an

inadequate level of HF knowledge. Their answers to the DHFKS questionnaire also

revealed there was deficiency in HF knowledge among cardiac nurses. This indicates

that this workshop training is beneficial for nurses, even those with sufficient HF

knowledge.

Second, the SCHFI validation revealed a lower level of Cronbach’s alpha

coefficients than preferable levels of 0.78 in two subscales. Due to the time

limitations of this PhD study, a full psychometric testing (i.e., test-retest, exploratory

factor analysis) could not be completed to provide in-depth examination of the

instrument. Further testing of the SCHFI in Vietnamese people will be required.

Third, blinding of participants and the outcome assessor (researcher) in the cRCT

about study allocation was not able to be undertaken due to practical reasons. There

were several nurses working in participating wards who attended the HF self-


management training (Phase One) and they might have provided more self-care

education to study participants in those wards, although this was unknown.

7.3 IMPLICATIONS OF THE STUDY

7.3.1 Implications for nursing education and practice

There are several implications regarding this study for nursing education. First,

chronic disease care needs to be taught to all undergraduate nursing students. In

addition, HF self-management education is feasible and appropriate for nurses to

provide, and hence, additional training should be provided to cardiac nurses,

especially those at a beginning stage of their nursing career. Vietnamese nurses

should provide education to patients to assist them to make and maintain healthy HF

self-care behaviours. The teach-back method also needs to be introduced to a wide

range of health professionals, not only nurses. Learning the teach-back method only

requires one hour or so. Hence, it can be introduced in hand-over meetings or ward

seminars to optimise the spread of this method.

This study also proposes implications for nurses in practicing self-management

education to patients with HF. It is important for them to understand the levels of the

HF knowledge of the patients and their experience in dealing with their symptoms.

The self-management education, when possible, needs to be individualised to meet

the learning needs of each person. Family members need to be involved during the

time the health education occurs whenever they are available, especially families of

those with hearing or cognitive impairment. Strategies toward improving patients’

confidence in self-care are necessary, as confidence is a determinant of self-care

maintenance. Pharmacists and dieticians ought to be involved as members of a

multidisciplinary health care team to provide consultation and improve patients’

adherence to prescribed medication and dietary regimens.


The principles of the teach-back method are simple and enable all health care

professionals to use them in delivering health education to patients. Closed questions

requiring yes or no answers should be avoided. Teaching information needs to be

divided into short and simple messages. Whenever health professionals close their

education session with patients, or move to introduce new information, they need to

ask patients to teach-back. The teach-back method should be prioritised to people

who are older or have lower reading capacity. The teach-back method is also

essential at discharge education to facilitate a safe transition from hospital to home. It

is advised to use supporting educational materials and visual aids, such as pictorial

images to educate people with reading difficulties.

7.3.2 Implications for health policies

This study has several recommendations to relevant policy makers at national and

hospital levels. First, it is recommended that funding be provided to hospitals to

implement self-management programs to people with heart failure. Nurses are

advised to be trained to be case managers to routinely provide follow up. In Vietnam,

having a mobile phone is common, even among those living in the countryside; tele-

monitoring for distance counselling to people with heart failure is possible, and needs

to be funded. When a flu vaccination is judged as irrelevant to preventative strategies

for people with heart failure in Vietnam, due to cost and low availability, this fact

requires the attention of health policy makers to seek resolutions. Flu vaccination is

recommended as an essential indication for people with heart failure, especially those

experiencing exacerbating symptoms.

In addition, this study confirmed the necessity of an electronic medical record system

in treating and following up patients. All information about patients, including

medication use, clinical tests, referral, discharge, and deaths is currently being


recorded in paper-based copies, which results in high levels of documentation

inaccuracy, and prevents the sharing of information between wards and monitoring

patients after discharge. Follow-up post discharge and distance counselling also

requires health policy makers’ attention.

7.3.3 Implications for further research

This study’s results have a number of implications for future research. First, the

systematic review found an inconsistent improvement in self-care, reduction of

hospital readmission, and health-related quality of life in in people living with

chronic diseases. Therefore, there is a necessity for more rigorous, large randomised

controlled trials to examine the effectiveness of the intervention using the teach-back

method on these outcomes in a range of chronic diseases.

Second, the translation and validation of the SCHFI enables health professionals and

researchers to use this instrument in studies measuring self-care behaviours in heart

failure. As the Cronbach’s alpha reliability of two subscales was lower than 0.78, a

full psychometric test of the SCHFI in a large population will be required to assure

its psychometric indices.

Third, failure to improve self-care confidence and a reduction in hospital readmission

in people with HF suggests that more exploratory studies are required to examine the

associated factors that determine the behaviours behind the reasons why patients are

or are not readmitted to hospitals. Refinement of self-management programs in heart

failure need to include strategies to improve patients’ social support and confidence

in order for improved self-care to be achieved. The attrition rate in this study (the

largest was 28% in the control group) suggests that future health care trials in

Vietnam should consider this high attrition rate in calculating the study sample sizes.


7.4 CONCLUSIONS

Finally, this study concludes that:

1. The teach-back method is effective for improving patient knowledge and

ought to be used by all health care professionals during their health

education sessions with patients in order to improve their understanding.

2. Self-management education should be introduced to all nurses who take

care of heart failure patients and encourage them to incorporate it in their

practice.

3. The SCHFI is an instrument with adequate reliability and validity that can

be used to measure self-care behaviours in Vietnamese speaking people

with heart failure.

4. The educational program using the teach-back method to inform self-

management support to people with heart failure has improved HF

knowledge and ought to be targeted to newly diagnosed people.

5. The educational program using the teach-back method to inform self-

management support to people with heart failure has improved self-care

maintenance and management for those who received it.

6. More strategies toward confidence and social support ought to be targeted

to achieve self-care in heart failure.

7. More studies are required to examine the factors regarding the decisions of

Vietnamese people with HF about whether to readmit to hospital or not.

178 References

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Appendices 207

Appendices

APPENDIX 1: MEDLINE SEARCH STRATEGY

S1 teach-back* OR "teach back" OR show-me OR "show me" OR "closing the loop" OR

"closing the cycle" OR “ask-tell-ask” OR "repeat* instruction"

S2 "health education*" OR "education* program#" OR discharge* OR "education* intervention"

S3

knowledge OR adherent* OR compliant* OR non-adherence OR "non-compliance" OR self-

management*

S4 "knowledge retention" OR "health literacy" OR self-efficacy OR readmission OR

comprehension OR “quality of life”

S5

Chronic* OR "heart failure" OR diabet* OR cardiovascular* OR cancer OR "respiratory

disease" OR asthma OR "chronic obstructive pulmonary disease" OR "chronic kidney

disease" OR arthritis OR epilepsy OR mental*

S6 S3 OR S4

S8 S1 AND S5 AND S6

208 Appendices

APPENDIX 2: MASTARI APPRAISAL INSTRUMENTS

Appendices 209

210 Appendices

Appendices 211

APPENDIX 3: DATA EXTRACTION TOOL

212 Appendices

Appendices 213

APPENDIX 4: EXCLUDED ARTICLES

Number Excluded papers Reasons for exclusion

1 Goossens E, Van Deyk K, Zupancic N,

Budts W and Moons P. Effectiveness of

structured patient education on the

knowledge level of adolescents and

adults with congenital heart disease.

European Journal of Cardiovascular

Nursing. 2014; 13(1), 63-70.

This study did not investigate the use of the

teach-back method.

2 Hahn SR, Friedman DS, Quigley HA, et

al. Effect of patient-centred

communication training on discussion

and detection of nonadherence in

glaucoma. Ophthalmology. 2010; 117(7):

1339-47.

Outcomes were physicians’ communication,

not the effect on patients’ non adherence.

3 Kumanyika SK, Adams-Campbell L, Van

Horn B, et al. Outcomes of a

cardiovascular nutrition counselling

program in African-Americans with

elevated blood pressure or cholesterol

level. Journal of the American Dietetic

Association. 1999; 99(11): 1380-91.

The intervention was aimed at lipid level and

blood pressure control after 12 months. The

intervention included food-picture cards,

nutrition guide, video and audiotape and

nutrition class. However, the use of the teach-

back method was not specified.

4 Mancuso CA, Peterson MGE, Gaeta TJ,

et al. A Randomised Controlled Trial of

Self-Management Education for Asthma

Patients in the Emergency Department.

Annals of Emergency Medicine. 2011;

57(6): 603-12.

The intervention included provision of a

workbook and asked patients to make a

contract to change their asthma behaviour.

Patients were taught to use inhaler device and

used a checklist to assess proficiency.

However, teach-back method was not

specified.

5 Ogedegbe G, Tobin JN, Fernandez S, et

al. Counselling African Americans to

Control Hypertension (CAATCH) Trial:

A Multi-Level Intervention to Improve

Blood Pressure Control in Hypertensive

Blacks. Circulation: Cardiovascular

Quality and Outcomes. 2009; 2(3): 249-

56.

This is a protocol with no actual data.

6 Rathkopf MM, Quinn JM, Proffer DL

and Napoli DC. Patient knowledge of

immunotherapy before and after an

educational intervention: a comparison of

2 methods. Annals of Allergy Asthma &

Immunology. 2004; 93(2): 147-53.

The participants were randomly assigned into

three groups: the control group, intervention

group 1 receiving an educational handout, and

intervention group 2 receiving one-on-one

educational sessions from 10-15 minute, but

the use of teach-back method was not

specified.

7 Verver S, Poelman M, Bögels A,

Chisholm S and Dekker F. Effects of

instruction by practice assistants on

inhaler technique and respiratory

symptoms of patients. A controlled

randomised videotaped intervention

study. Family Practice. 1996; 13(1): 35-

40.

The intervention involved instruction by a

practice assistant and video recording the

inhaler’s technique which was scored based on

nine items. The use of teach-back was not

included.

8 Kandula NR, Nsiah-Kumi PA, Makoul

G, Sager J, Zei CP, Glass S, Stephens

The intervention was a computer-based

program focusing on graphics, animation,

http://www.ncbi.nlm.nih.gov/pubmed/?term=Kandula%20NR%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Nsiah-Kumi%20PA%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Makoul%20G%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Makoul%20G%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Sager%20J%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Zei%20CP%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Glass%20S%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Stephens%20Q%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

214 Appendices

Q, Baker DW. The relationship between

health literacy and knowledge

improvement after a multimedia type 2

diabetes education program. Patient

Education Counselling. 2009

Jun;75(3):321-7.

spoken audio and on-screen text. The use of

teach-back was not included.

9 Loislee A. Schwartz. A Comparison

Between Two Types of Preventive

Educational Programs for a Population at

High Risk for Cardiovascular Disease.

Dissertation at Medical College of

Virginia-Virginia Commonwealth

University, 1988.

Participants were those with elevated HDL

ratios, and the outcomes were changes in HDL

ratios after intervention. The use of teach-back

method was not included.

10 Ivey SL, Tseng W, Kurtovich E, et al.

Evaluating a Culturally and Linguistically

Competent Health Coach Intervention for

Chinese-American Patients With

Diabetes. Diabetes Spectrum. 2012;

25(2): 93-102.

Outcome of interest was clinical HbA1C,

which was not stated in selected outcomes.

11 Rothman RL, DeWalt DA, Malone R, et

al. Influence of Patient Literacy on the

Effectiveness of a Primary Care-Based

Diabetes Disease Management Program.

JAMA: The Journal of the American

Medical Association. 2004; 292(14):

1711-6.

Outcomes of interest were HbA1C and blood

pressure, which were not stated in selected

outcomes.

http://www.ncbi.nlm.nih.gov/pubmed/?term=Stephens%20Q%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.ncbi.nlm.nih.gov/pubmed/?term=Baker%20DW%5BAuthor%5D&cauthor=true&cauthor_uid=19395223

http://www.sciencedirect.com/science/article/pii/S0738399109001554




http://www.ncbi.nlm.nih.gov/pubmed/19395223

http://www.ncbi.nlm.nih.gov/pubmed/19395223

Appendices 215

APPENDIX 5: OVERVIEW OF SELECTED ARTICLES First

author,

year

Study

design/Measured

outcomes

Participant Intervention/control care/ Study details Length of educational

session/Follow-

up/Educator/Location

Baseline characteristics Notes

Bosnic-Anticevich

SZ, 2010

Study design: Randomised parallel-

group single-blind

(n=52, male =19, female =33 )

Measured outcomes

Correct pMDI

technique score

(maximum score of 8

) over 4 visits

Inclusion: Patients over 18 years,

currently using

pressurized metered-dose inhaler (pMDI)

for asthma or COPD.

Exclusion criteria: first-time pMDI

users, those did not

self-administer their MDI, those who used

spacer.

Standard instruction group: Patients received verbal instructions (researcher

read all 8 steps of pMDI technique, using

illustration in leaflet as visual guide) and written information (product information

leaflet).

Extended instruction group: Patients

received verbal instructions, written

information and the teach-back method

with physical demonstration p MDI with a placebo.

Study details: Patients were required to

visit community pharmacy at least 4 times. Visit 1, patients were taught use of MDI

and asked to demonstrate back. In visit 2

and 3, if pMDI technique was incorrect, patient teaching were repeated until correct

technique was achieved for a maximum 3

times.

Length of education:

not given

Follow-up: 4 visits

(one visit every 4 weeks) to community

pharmacy

total duration = 16

weeks

Educator: Two

pharmacy student researchers

Location: Eight

community pharmacies in Sydney

Standardised group: n=26 Age: 43(18) range 22-82 years

Duration of years: 19 (13) range 1 month – 45

years Duration of pMDI use: 14 (11) ranging 1

month – 38 years

80% asthma, 16% COPD, 4% sleep apnoea

Extended group: n=26 Age: 47(20) range 21-77 years

Duration of years: 16 (13) range 1 month – 49 years

Duration of pMDI use: 11 (7) ranging 1

month – 25 years 89% asthma, 11% COPD

No important differences

between 2 groups

at the baseline

Davis KK,

2012

Randomised

controlled trial (n =

125, male = 66, female = 59)

Measured outcomes:

- HF self-care index (by SHFCI)

- HF knowledge (by

the Dutch HF scale) - Thirty-day

readmission

Patients aged 21 and

over having primary

diagnosis of systolic or diastolic HF and

were diagnosed with

mild cognitive impairment,

anticipated to return

to community setting

Exclusion criteria: having Alzheimer

disease, severe psychiatric illness,

neurological

condition, stroke,

blind, major hearing

loss, end-of-life

condition, weighted > 350 lb.

Control group (n=62) received a verbal

review of the HF booklet (symptoms

recognition, exercise, dietary, fluid restriction, mediation adherence).

Intervention (n=63) delivered during

hospitalisation, including a workbook (pictograms, self-care schedule,

medication schedule, future appointment

and symptoms documentation). A case manager was employed to assist patients

integrate self-care tasks into their daily

activities. Patients also participated in a verbal and interactive problem-solving

training session with scenarios, which was

recorded for patient to review. A post

discharge phone call was done 24-72h

after discharge.

Study details: The intervention aimed to improve self-care, knowledge of patients

with mild cognitive impairment (mostly

Black people). A case manager helped patients to create self-care schedule

integrated into daily living. The teach-back

method was used in hospital and after

Length of educational

session: total 44

minutes during hospitalisation

Follow-up: 30 days

follow-up (RCT was conducted during a 12-

month period)

Educator: The case manager

Location: a large

academic hospital in America.

Control (n=62)

Age: 57(13)

Male 56%

Co-morbidity index:

None 18%

Low (1-2): 47% Moderate (3-4): 31%

High (>4): 1%

Intervention (n=63)

Age: 60 (13)

Male 49%

Co-morbidity index: None 14%

Low (1-2): 43%

Moderate (3-4): 40%

High (>4): 3%

Discharge phone

calls were used.

216 Appendices

First

author,

year

Study

design/Measured

outcomes Participant Intervention/control care/ Study details


session/Follow-

up/Educator/Location Baseline characteristics Notes

discharge to recall knowledge and self-

care. Patients were given audiotape recorded scenarios, equipment (audiotape,

audio cassette, scale, measuring cups, pill

box…)

DeWalt DA 2006

Randomised controlled trial (n

=123, male =60,

female =63)

Measured outcomes

-Readmission or death

(from patients or medical records)

- HF –related quality

of life (Minnesota Living with HF

Questionnaire)

-HF self-efficacy (8-item scale)

-HF knowledge

(knowledge test used for this trial)

-HF behaviours (how

often patients

weighted themselves)

Inclusion: Patients aged 30 – 80 having

confirmed diagnosis

of HF with New York Heart

Association class II-

IV Exclusion criteria:

Patients with

dementia (moderate to severe); terminal

illness, hearing

impairment, blindness, substance

abuse, kidney failure

or dialysis, going to have heart transplant

or surgery

Control group (n=64): standard care plus one HF education pamphlet

Intervention group (n=59): one-hour

education using a booklet for low literacy people and a digital scale. Educator used

the teach-back to improve comprehension.

Educator taught patients to manage weight fluctuation and self-adjust diuretics.

Schedule follow-up phone calls were made

(days 3, 7, 14, 21, 28, 56) and monthly during month 3-6.


session: one hour

Follow-up: 12 months

Educator: Clinical pharmacist or health

educator

Location: University of North Carolina

General Internal

Medicine Practice When: Regular clinic

visit

Control

(n=64)

Intervention

(n=64)

The QoL was different

significantly in

baseline (p=0.0028)

Age (mean,

sd)

62 (11) 63 (9)

Male, % 41% 58%

Inadequate literacy 39% 42%

Hypertension 89% 86%

Diabetes, % 52% 59%

Creatinine,

mg/dl

1.3 1.2

Time with

HF, mean, sd

7 (8) 6 (9)

NYHA class,

%

II: 47%;

III: 51%; IV: 2%

II: 53%; III:

40%; IV: 7%

Systolic

dysfunction, %

44% 39%

Knowledge,

mean percent

57% 55%

Self-efficacy, mean score

22 22

Health-related QoL, mean score (range 0-105)

C (57); I (45)

Kiser K, 2012

Randomised controlled trial (n=99,

male = 34, female

=65))

Measured outcomes

MDI, Diskus and Handihaler technique

score

Selection criteria: Adult patients with

diagnosis of COPD,

chronic bronchitis,

emphysema treated

with inhaled

medication

Excluded criteria: exacerbated COPD

or those with asthma only

Intervention (n=67): individual education session, Living with COPD handout,

verbal explanation of the handout, teach-

back and demonstration of appropriate use

of MDI

Control (n=32): received standard care


15 – 30 minutes

Follow-up: 2-8 weeks

Educator: Research

assistant

Location: general

internal medicine practice, University of

North Carolina

Control

(n=32) Intervention

(n=67)

Age (mean,

range)

63 (44-84) 63 (43-84)

Female % 66% 64%

Insured % 97% 91%

Low literacy

%

33% 37%

FEV1

predicted

(mean, sd)

57.6 (17.2) 53.6 (20.4)

Oxygen use 19% 30%

Appendices 217

First

author,

year

Study

design/Measured



session/Follow-


Krumholz

HM, 2002

Prospective

randomised trial n = 88 (male = 50, female

=38)

Measured outcomes One-year readmission

or mortality

Costs of care

Inclusion: Patients

aged 50 and over diagnosed with HF.

Exclusion:

transferred from other hospitals, from

nursing home,

terminal illness,

Intervention: was conducted during

hospital discharge; a one-hour education; using a teaching booklet on sequential care

domains included illness, medications,

deteriorated signs and symptoms. Follow-up phone calls were used periodically

during one year for reinforcing care

domains and warning signs. Control group: as standard care

The intervention involved two phases. The

first phase was conducted in hospital discharge (nurse educated patients using

booklet to teach care domains). The

second phase was conducted after discharge by using telephone calls during

12-month follow-up. The phone call was

aimed at reminding patients of taught knowledge, not to modify or recommend

treatment regimens.

Length educational

session: One hour Follow-up: 12 months

Educator: an

experienced cardiac nurse

Location: Yale New

Haven Hospital, America

When: During 2

weeks of hospital discharge or home visit

and follow-up

Control

(n=44)

Intervention

(n=44)

Data was analysed

with intention-to-treat approach.

Involved high-risk

participants (with history of cardiac

diseases, high

prevalence of co-morbidities)

Age 71.6±10.3 75.9±8.7

Male, n, % 29 (66%) 21 (48%)

Prior

myocardial

infarction

29 (66%) 24 (55%)

Prior

Congestive

HF

35 (80%) 31 (70%)

Prior CABG 16 (36%) 7 (16%)

Prior PTCA 9 (20%) 5 (11%)

Diabetes 23(52%) 23 (52%)

Systolic blood

pressure (mmHg)

157±35 162 ±38

Negaramdeh

R, 2011

Randomised

controlled trial (n = 127, male = 69,

female = 58)

Measured outcomes

Knowledge score (a

22-item diabetics questionnaire from 0 -

44 score)

Adherence to diet (by a self-structured nine-

item from 0-9 score)

Adherence to medication using the

Morisky Medication

Adherence Scale

Inclusion: Patients ≥

18 years old, with type 2 diabetes ≥ 6

months, having low

health literacy (≤59

in full TOFHLA

instrument), no former participant in

diabetes education

study. Exclusion: having

mental, visual and

learning disabilities

Pictorial image (n=44): three weekly 20-

minute sessions, provision of pictorial images and information of diabetes-related

health care.

Teach-back (n=43): three weekly 20-

minute sessions, provision of educational

content as for pictorial image group, the use of teach-back in teaching and assessing

patients’ understanding, important

instructions were written down. Control (n=40): receive standard care

(provision of diabetes-related educational

brochure, answering patients’ questions)

Length of education: three weekly session, 20 minutes each

Follow-up: 6 weeks

Educator: a

community health

nurse Location: a secondary

level diabetics clinic in

Kurdistan

Mean, sd Control

(n=40)

Pictorial

(n=44)

Low literacy

participants were particularly

recruited. The

educational

sessions for 3

groups were conducted by the

same community

health nurse, which raised the

risk of

contaminated intervention.

Age 49.12±8.78 51±9.74

Male n, % 25 (56.8%) 22 (55%)

Knowledge

(0-44)

27.57±3.59 27.27±3.59

Medication

adherence (0-

8)

4.52±1.74 4.33±1.62

Dietary adherence (0-

9)

4.65±1.36 4.6±1.19

Press V, 2012

Randomised controlled trial (n=50,

male =15, female =

35) Measured outcomes

Metered dosed Inhaler

technique misuse Acute 30-day health-

related events

Inclusion: Hospitalized patients

(aged 18 and over)

with asthma or COPD, expect to use

MDI post-discharge

Exclusion: staying in intensive care,

previous study

participants.

Teach-to-goal group (n=24): teach-back plus demonstration of correct use of MDI,

written instruction and pamphlet about

asthma/COPD. Brief intervention (n=26): verbal

instructions on the use of MDI (no

demonstration) and verbal education on the pamphlet about asthma/COPD.


mean of 6.3 minutes in

the Intervention group

vs 2 minutes in control group

Follow-up: inhaler

technique was assessed right after intervention

instruction. Acute

health-related events

BI n=26 TTG n=24 More participants in control group

were considered

low health literacy than in control

group, and 100%

participants in both groups used

MDI previously,

which may result

Age (mean,

sd)

51.0 (13.6) 56.4 (19.0)

Asthma (vs

COPD) n, %

11 (42) 9 (38)

Female n,% 18 (69) 16 (67)

Ever smoker

n,%

17 (52) 17 (48)

Below adequate

5 (36) 1 (9)

218 Appendices

First

author,

year

Study

design/Measured



session/Follow-


were followed for 30

days post discharge Educator: A trained

research educator

Location: urban academic centre,

University of Chicago

health literacy in overestimate the

effect of intervention

Previous use

of MDI vs Diskus (%)

100% vs

39%

100% vs

33%

FEV1 (mean,

sd)

44.1 (18.6) 47.4 (9.5)

BP, mmHg, mean, sd

134.2 (18.4)

138.9 (22.3)

Diabetes

knowledge score, median

(IQR) range

0-100

40 (20-50) 60 (40-70)

Rydman RJ, 1999

Prospective randomised controlled

trial (n = 68¸ male =

17, female = 51) Measured outcomes

Inhaler technique

(breath actuated inhaler BAI and

metered dosed inhaler

MDI)

Inclusion: asthmatics with 6

months being in

pulmonary/asthma clinic

Exclusion: missed

more than 25% appointments in 6

last months, had

previous ED visit,

took more than 10mg

oral prednisone, unable to read or

understand English

I (n=36): verbal instruction, demonstration of breath actual inhaler technique, teach-

back, autohaler package insert instruction

C (n=32): autohaler package insert instruction, patients demonstrated inhaler

technique with no feedback

Intervention participants were instructed to use inhaler, then were given feedback and

repeated education until proper inhalation

technique was achieved. MDI might be

alternative for BAI. In end of program,

patient demonstrated back to a physician, and again received instruction on correct

use of BAI and MDI.

Length of education: not given

Follow-up: 8-20 weeks

Educator: A trained instructor

Location: asthma

clinic of Cook County Hospital, America

Control

n=32 Intervention

(n=36)

Approximately 95% participants

in both

intervention and control group were

given instructions

on MDI use, resulted in

possibility of

overestimate effect

of intervention

Age

(mean ± sd)

43.58

±13.48

49.48 ±16.49

Male 27.78% 21.21%

Receive MDI

use instruction

prior to study

94.44% 96.97%

FEV1 (litre) prestudy

(mean±sd)

2.05±0.75 2.18±0.95

Swavely D,

2013

Before-After study (n

= 277, male = 94, female = 183)

Measured outcomes

Diabetics knowledge (>=80% correct

answers in Spoken

Knowledge in Low Literacy in Diabetes.

Self-care

Self-efficacy HbA1C level

Inclusion criteria:

Patients aged 18 and over; diagnosed with

type 2 diabetes

Intervention included teaching about

human body and disease, using map visuals, cues, questions, discussion cards,

group interaction, and facilitation to

empower patients to be responsible for taking themselves. Patients also have a

one-hour individual session with dietician

and pharmacist to work on diet and medication. Patients and their previous

physician were provided targets and goals

in communication, care coordination, and assistance in doing self-care activities.

Staff received education related to

intervention (health literacy, communication, cultural tailoring, the

teach-back method…) to be educator. The

program is aimed at improving self-efficacy


program consisted of 13 educational hours

lasting over 12 weeks.

Follow-up: 12 months Educator: Staff

experienced in

providing diabetes education and a

dietitian and

pharmacist

Location: from 6

primary care medical

practices, America

Age (mean, sd): 56.8±10.4

Female: 66% Health insurance (Medicare, Medi aid):

89.1%, no insurance: 10.9%

Adequate literacy: 67 (63.2%); inadequate literacy: 39 (36.8%)

Social support: married: n=44 (41.5%); single

n=31 (29.2%); widow/divorced/separate n=30 (28.4%)

Ethnicity: Hispanic n=82 (77.4%); Back and

White n=18 (17%), other n=5 (4%)

Participants were

typically low income, Hispanic,

low health literacy

level)

Appendices 219

First

author,

year

Study

design/Measured



session/Follow-


White M,

2013

Cohort n =276 (male

= 123, female = 153) Measured outcomes:

-7 day post-discharge

knowledge retention (answered correctly at

least 75% teach-back

questions) -90-day Hospital

readmission

- 15-month follow-up death

Inclusion: Patients

aged 65 and over with primary or

secondary diagnosis

of HF.

Exclusion:

Participants with

severe cognitive impairment and

severe dementia

Intervention was conducted as standard

care. The intervention included handouts adapted from America Heart Association

guideline, provision of weighting scale in

hospital and included family member and caregivers if possible.

Intervention included rationale for fluid

and salt restriction, adherence to medication, daily weighing, quit smoking,

warning signs and activities. 188/276

participants received intervention at home. Knowledge was assessed within 7 days

post discharge and if patients answered

incorrectly, education was repeated until correct answers were achieved. Hospital

readmission and death number were

tracked in 90 days and 15 months respectively.


average 34 minutes (ranging 15-120

minutes)

Follow-up: 7 days for knowledge retention,

90 days for hospital

readmission and 15 months for deaths

Educator: Two

registered nurses Location: cardiology

and medical services at

University of California, USA

Age (mean, sd): 80.2 ±8.9;

Women (n,%): 153 (55.4%); BNP (pg/dL, n=149) mean, sd: 975.6 (986.3);

Ẹjection fraction <60%, n(%): 97 (35.3%)

Hg (md/dL, n=183): 11.34 (1.7) On home oxygen, n(%): 34 (12.3%)

Independent with daily living activities, n(%):

86 (32.2%) Diagnosed hypertension: 168 (60.9%)

Diagnosed end-stage renal disease: 22 (8%)

Diagnosed diabetes: 96 (34.8%) Diagnosed COPD: 44 (15.9%)

Teach-back was

standard care. Patients was old

and majority of

participants in baseline had

comorbidities and

were dependent in living activities

220 Appendices

APPENDIX 6: JBI GRADE OF EVIDENCE

Appendices 221

APPENDIX 7: WORKSHOP PROGRAM

WORKSHOP PROGRAM

“SELF-MANAGEMENT PROGRAM FOR PEOPLE WITH HEART FAILURE AND THE

TEACH-BACK METHOD”

The program was distributed to participants in Vietnamese.

1. Time: from 8h00 - 16h00, 20/12/2013

2. Venue: Faculty of Nursing, Hanoi Medical University

3. Objectives:

Provide cardiac nurses in hospitals with HF self-management and the use of the teach-back method

in health education

4. Participants: 20 nurses working in cardiac wards of Bach Mai hospital, E Hospital, Huu Nghi

hospital and Hanoi Hospital of Cardiology

5. Facilitator: Dinh Thi Thuy Ha, lecturer of Faculty of Nursing and Midwifery, Hanoi Medical

University

6. Enclosed material(s): the Living everyday with heart failure (Vietnamese version)

7. Details of program

222 Appendices

Time Contents Responsible

8.00 Registration Instructor

8.15 Welcome remark, introduction of the workshop purposes and

participants

Instructor

8.30 The Dutch heart failure knowledge scale and demographic

questionnaire: distribution and response time

Participants

8.50 Ice breaking: discussion on communication and health education

between patients and health care professionals in hospital

settings

Instructor and participants

9.00 Presentation: the teach-back method and sample video

presentation

Instructor

9.45 Discussion: how to use the teach-back method to educate

patients with heart failure

Participants/Instructor

10.00 Tea break

10.15 Presentation: HF self-management Instructor

11.00 Scenario 1: salt reduction Participants/Instructor

11.30 Scenario 2: weigh monitoring Participants/Instructor

12.00 Scenario 3: symptom recognition Participants/Instructor

12.30 Lunch

13.30 –

15.30

Role play, using the teach-back observation checklist for self-

evaluation

Participants/Instructor

15.30 Distribution of The Dutch heart failure knowledge scale and

evaluation of workshop

Participants

16.00 Summary and closing remark Instructor

Appendices 223

APPENDIX 8: PRESENTATION OF THE HF SELF-MANAGEMENT AND

THE TEACH-BACK METHOD

PRESENTATION ON THE TEACH-BACK METHOD

224 Appendices

Appendices 225

226 Appendices

Appendices 227

228 Appendices

Appendices 229

230 Appendices

Presentation on heart failure self-management education

Appendices 231

232 Appendices

Appendices 233

234 Appendices

APPENDIX 9: COPYRIGHT PERMISSION OF “LIVING EVERYDAY WITH

MY HEART FAILURE”

Appendices 235

APPENDIX 10: TEACH-BACK OBSERVATIONAL TOOL

236 Appendices

APPENDIX 11: DEMOGRAPHIC QUESTIONNAIRE FOR NURSES

Please complete the following questions

1. Age (in years):……………………………………………………………………

2. Gender:…………………………………………………………………………...

3. Workplace:……………………………………………………………………….

4. Number of years as a nurse…………..…………………………………………..

5. Number of years working in a cardiac ward……………………………………..

6. Please list your highest qualification…………………………………………….

Please tick one box for appropriate answer to the following questions:

7. How confident are you in providing health education for patients in your ward?

□ Very confident □ Confident □ Somewhat confident □ Not confident at all

8. How often do you provide health education for patients in your ward?

□ Always (daily) □ Frequently (weekly) □ Sometimes (monthly) □ Rarely or never

9. Do you know what the teach-back method is?

□ Yes □ No

Thank you for completing this questionnaire!

Appendices 237

APPENDIX 12: DUTCH HEART FAILURE KNOWLEDGE SCALE

1. How often should patients with severe heart failure weigh themselves?

❑ every week

❑ now and then

❑ every day

2. Why is it important that patients with heart failure should weigh themselves regularly?

❑ because many patients with heart failure have a poor appetite

❑ to check whether the body is retaining fluid

❑ to assess the right dose of medicines

3. How much fluid are you allowed to take at home each day?

❑ 1.5 to 2.5 litres at the most

❑ as little fluid as possible

❑ as much fluid as possible

4. Which of these statements is true?

❑ when I cough a lot, it is better not to take my heart failure medication

❑ when I am feeling better, I can stop taking my medication for heart failure.

❑ it is important that I take my heart failure medication regularly

5. What is the best thing to do in case of increased shortness of breath or swollen legs?

❑ call the doctor or the nurse

❑ wait until the next check-up

❑ take less medication

6. What can cause a rapid worsening of heart failure symptoms?

❑ a high-fat diet

❑ a cold or the flu

❑ lack of exercise

7. What does heart failure mean?

❑ that the heart is unable to pump enough blood around the body

❑ that someone is not getting enough exercise and is in poor condition

❑ that there is a blood clot in the blood vessels of the heart

8. Why can the legs swell up when you have heart failure?

❑ because the valves in the blood vessels in the legs do not function properly

❑ because the muscles in the legs are not getting enough oxygen

❑ because of accumulation of fluid in the legs

238 Appendices

9. What is the function of the heart?

❑ to absorb nutrients from the blood

❑ to pump blood around the body

❑ to provide the blood with oxygen

10. Why should someone with heart failure follow a low salt diet?

❑ salt promotes fluid retention

❑ salt causes constriction of the blood vessels

❑ salt increases the heart rate

11. What are the main causes of heart failure?

❑ a myocardial infarction and high blood pressure

❑ lung problems and allergy

❑ obesity and diabetes

12. Which statement about exercise for people with heart failure is true?

❑ it is important to exercise as little as possible at home in order to relieve the heart

❑ it is important to exercise at home and to rest regularly in between

❑ it is important to exercise as much as possible at home

13. Why are water pills prescribed to someone with heart failure?

❑ to lower the blood pressure

❑ to prevent fluid retention in the body

❑ because then they can drink more

14. Which statement about weight increase and heart failure is true?

❑ an increase of over 2 kilograms in 2 or 3 days should be reported to the doctor at the next check-up

❑ in case of an increase of over 2 kilograms in 2 or 3 days, you should contact your doctor or nurse

❑ in case of an increase of over 2 kilograms in 2 or 3 days, you should eat less

15. What is the best thing to do when you are thirsty?

❑ suck an ice cube

❑ suck a lozenge*

❑ drink a lot

* in Dutch a ‘dropje’, which is a very salty lozenge

Appendices 239

APPENDIX 13: EVALUATION FORM FOR THE WORKSHOP

Evaluation Forms were distributed to participants in Vietnamese language

EVALUATION FORM

Self-management program for people with heart failure and

The Teach-back method

We would be delighted to receive your thoughts, reflection and evaluation of the workshop.

Please indicate a score for the following from 1 – 5:

1= Strongly disagree 2 = Disagree 3 = Neither agree or disagree

4 = Agree 5 = Strongly Agree

TT Content Score

1. The workshop was well organised

2. The workshop provided useful information

3. The length of the workshop was appropriate

4. The workshop has provided me with a better understanding about the teach-back

method

5. The workshop has provided me with a better understanding about self-management

for heart failure

6. I am now confident in using the teach-back method on health education for patient

7. I will use the teach-back method in teaching patient

8. I will introduce the teach-back method to my colleagues

1. Which sessions were valuable to you and why? If not, why not?

…………………………………………………………………………………………

…………………………………………………………………………………………

…………………………………………………………………………………………

2. Which sessions were less valuable to you and why?

…………………………………………………………………………………………

…………………………………………………………………………………………

…………………………………………………………………………………………

3. What three key messages will you take back to your colleges and team?

1)…………………………………………………………………………………….

240 Appendices

2)…………………………………………………………………………………….

3)…………………………………………………………………………………….

4. How did you rate your instructor:

Contents Score Comments

1. Quality of presentations

2. Teaching style

3. Manage time

4. Attract to listeners

Score: 1 - Weak; 2 – Not good; 3 – Neither good or weak; 4 - Good; 5 – Very good

5. Workshop preparation

Contents Score Comments

1. Workshop room

2. Display of materials

3. Contents of materials

4. Teaching aids (computer, projector)

5. Refreshments

Score: 1 - Weak; 2 – Not good; 3 – Neither good or weak; 4 - Good; 5 – Very good

6. Please provide any other comments

…………………………………………………………………………………………

…………………………………………………………………………………………

…………………………………………………………………………………………

Appendices 241

APPENDIX 14: PERMISSION FOR THE SELF-CARE OF HEART FAILURE

INDEX V6.2

242 Appendices

APPENDIX 15: SELF-CARE OF HEART FAILURE INDEX

All answers are confidential.

Think about how you have been feeling in the last month or since we last spoke as you complete these

items.

SECTION A:

Listed below are common instructions given to persons with heart failure. How routinely do you do the

following?

Never or

rarely

Some-

times Frequent-ly

Always or

daily

1. Weigh yourself? 1 2 3 4

2. Check your ankles for swelling? 1 2 3 4

3. Try to avoid getting sick (e.g., flu shot,

avoid ill people)?

1 2 3 4

4. Do some physical activity? 1 2 3 4

5. Keep doctor or nurse appointments? 1 2 3 4

6. Eat a low salt diet? 1 2 3 4

7. Exercise for 30 minutes? 1 2 3 4

8. Forget to take one of your medicines? 1 2 3 4

9. Ask for low salt items when eating out or

visiting others?

1 2 3 4

10. Use a system (pill box, reminders) to help

you remember your medicines?

1 2 3 4

SECTION B:

Many people have symptoms due to their heart failure. Trouble breathing and ankle swelling are common

symptoms of heart failure.

In the past month, have you had trouble breathing or ankle swelling? Circle one.

No Yes

11. If you had trouble breathing or ankle swelling in the past month… (circle one number)

Have not had

these

I did not

recognise it

Not

Quickly

Somewhat

Quickly Quickly

Very

Quickly

How quickly did you

recognise it as a symptom of

heart failure?

N/A 0 1 2 3 4

Appendices 243

Listed below are remedies that people with heart failure use. If you have trouble breathing or ankle swelling,

how likely are you to try one of these remedies?

(circle one number for each remedy)

Not

Likely

Somewhat

Likely Likely Very Likely

12. Reduce the salt in your diet 1 2 3 4

13. Reduce your fluid intake 1 2 3 4

14. Take an extra water pill 1 2 3 4

15. Call your doctor or nurse for

guidance

1 2 3 4

16. Think of a remedy you tried the last time you had trouble breathing or ankle swelling, (circle one

number)

I did not try

anything

Not

Sure

Some-

what Sure Sure

Very

Sure

How sure were you that the remedy helped or did

not help? 0 1 2 3 4

SECTION C:

In general, how confident are you that you can:

Not

Confident

Somewhat

Confident

Very

Confident

Extremely

Confident

17. Keep yourself free of heart failure

symptoms? 1 2 3 4

18. Follow the treatment advice you

have been given? 1 2 3 4

19. Evaluate the importance of your

symptoms? 1 2 3 4

20. Recognise changes in your health if

they occur? 1 2 3 4

21. Do something that will relieve your

symptoms? 1 2 3 4

22. Evaluate how well a remedy works? 1 2 3 4

244 Appendices

APPENDIX 16: ASSESSMENT TOOL FOR PANEL

ASSESSMENT OF THE SELF-CARE FOR HEART FAILURE INDEX

The assessment forms were distributed to panellists in Vietnamese language

Please read items/questions in the following questionnaire and assess each item on 4 criteria: Relevance, Clarity,

Completeness and Appropriateness with score 1, 2, 3, 4 as below:

1. Relevance: Is each item in the instrument relevant to heart failure

2. Clarity: You need to judge of each item/question is clear in meaning, presentation and is easy to be

understood by aged people and those with lower reading capacity? If there is any item is difficult to

understand or mislead readers, please give comments on how the item can be revised.

3. Comprehension: please judge if the item/question is necessary in the instrument or can be deleted (if

delete, please list the rationales)

4. Appropriateness and adequacy of scale: please judge of scale for each item is appropriate,

quantitative and easy to be understood, easy to score/answer.

Please tick X in the appropriate column in each criteria

Appendices 245

Items/Sub-items

Relevance

1. Item is not relevant.

2. Item needs major revision

to be relevant

3. Item needs minor revision

to be relevant.

4. Item is relevant.

Clarity

1. Item is not clear.

2. Item needs major

revision to be clear.

3. Item needs minor

revision to be clear.

4. Item is clear.

Comprehension

1. Item should be

deleted.

2. Item should be

retained

Appropriateness and adequacy

of rating scale for each item

1. Rating scale is not

appropriate.

2. Rating scale needs major

revision to be appropriate.

3. Rating scale needs minor

revision to be appropriate.

4. Rating scale is appropriate.

Assessment 1 2 3 4 1 2 3 4 1 2 1 2 3 4

SECTION A: Listed below are common

instructions given to persons with heart

failure. How routinely do you do the

following? (answers are: Never or rarely;

Sometimes; Frequently; Always or daily)

1. Weigh yourself?

2. Check your ankles for swelling?

3. Try to avoid getting sick (e.g., flu

shot, avoid ill people)?

4. Do some physical activity?

5. Keep doctor or nurse appointments?

6. Eat a low salt diet?

246 Appendices

7. Exercise for 30 minutes?

8. Forget to take one of your

medicines?

9. Ask for low salt items when eating

out or visiting others?

10. Use a system (pill box,

reminders) to help you remember

your medicines?

Section B

Many patients have symptoms due to their

heart failure. Trouble breathing and ankle

swelling are common symptoms of heart

failure.

In the past month, have you had trouble

breathing or ankle swelling? Circle one.

0) No

1) Yes

11. If you had trouble breathing or ankle

swelling in the past month…

How quickly did you recognise it as a

symptom of heart failure?

(Answers are: have not had these, I did not

recognise it, Not Quickly, Somewhat

quickly, Quickly, Very quickly)

Listed below are remedies that people with

heart failure use. If you have trouble

breathing or ankle swelling, how likely are

you to try one of these remedies? (circle

one number for each remedy)

Appendices 247

Answers are: Not likely, Somewhat likely,

likely, very like

12. Reduce the salt in your diet

13. Reduce your fluid intake

14. Take an extra water pill

15. Call your doctor or nurse for

guidance

16. Think of a remedy you tried the

last time you had trouble

breathing or ankle swelling,

(circle one number)

(Answers are: I did not trying anything,

not sure, somewhat sure, sure, very sure)

How sure were you that the remedy

helped or did not help?

SECTION C:

In general, how confident are you that you

can:

(Answers for each question are: not

confident, somewhat confident, very

confident, extremely confident)

17. Keep yourself free of heart failure

symptoms?

18. Follow the treatment advice you

have been given?

248 Appendices

19. Evaluate the importance of your

symptoms?

20. Recognise changes in your health if

they occur?

21. Do something that will relieve your

symptoms?

22. Evaluate how well a remedy works?

Appendices 249

APPENDIX 17: FOLLOW-UP QUESTIONNAIRE

PARTICIPANT FOLLOW-UP QUESTIONS

Name: _________________________________________________

Participant number: _____________________________________

Date: __________________________________________________

To be reported by patients via telephone follow-up. Researcher provides education whenever patients

answer questions incorrectly or inappropriately.

For control group, researcher asks these questions but does not provide further education.

1. Do you currently have symptoms including:

Symptoms Yes No What do you do if you have that

symptom

Teach-back

(Yes/No)

Ankle swelling

Breathlessness

Cough

Chest pain

Weight gain

Dizziness/headache

Palpitation

Other

2. What did you have for breakfast/lunch today?

Answer…………................................................................................................................. ............................

Teach back............................................................................................................. ..........................................

.........................................................................................................................................................................

3. What is your weight this morning (or yesterday)? Is it stable? Did you write it down in your diary?

Weight…………............................................................................. ................................................................

Teach-back......................................................................................................................... .............................

4. How much fluid did you drink yesterday? How did you measure that amount?

Amount………………………………………………………………………………………………………

Teach-back ………………………………………………………………………………………………….

5. Tell me what medications you took yesterday? Did you take any other medications (even not

prescribed)? Did you forget any dose/pill?

250 Appendices

..........................................................................................................................................................................

.................................................................................................................................................................

6. What exercise did you do yesterday?

..........................................................................................................................................................................

........................................................................................................................................ ..................................

...................................................................................................................................................................

7. Tell me how do you know your symptoms are worsening and you need to come back hospital?

……………………………………..................................................................................................................

...............……………………………………........................................................................................

8. Did you or did anyone help you to find more information about heart failure? Where did you/they find

that information? (Examples: internet, papers, leaflet, community pharmacists?)

..........................................................................................................................................................................

..................................................................................................................................................................

9. Were you readmitted to hospital in last two weeks? Why?

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

…………………………………………………………………………………………………………….

10. Did you need to visit doctor in the last two weeks? Why?

………………………………………………………………………………………………………………

………………………………………………………………………………………………………………

……………………………………………………………………………………………………………..

Appendices 251

APPENDIX 18: PARTICIPANTS’ DEMOGRAPHIC QUESTIONNAIRE

PARTICIPANT CHARACTERISTICS FORM

Name: _____________________________________________________________

Participant number: _________________________________________________

Date: ______________________________________________________________

Completed once only with assistance from Researcher

Age (date of birth)

Gender (circle)

Male 1

Female 2

Marital status (circle)

Single 1

Married 2

Divorced 3

Separated 4

Widowed 5

Highest level of education (circle)

Non-formal education 1

Primary 2

Secondary 3

High school 4

Vocational Training 5

College 6

University (Bachelor) 7

Postgraduate (Master or PhD) 8

Occupation (circle)

Unemployed 1

Worker 2

Farmer 3

Business person 4

Government staff 5

Retired 6

252 Appendices

Length of HF diagnosis

HF category (NYHA)

Number of family members living in house

Who is main carer

Type(s) of health insurance held (circle all

that apply)

Government 1

Private 2

None 3

Other (specify):___________________ 4

Method of medical payment for hospital

cost (circle)

Total reimbursement 1

Partial reimbursement (specify percentage):_______%

reimbursed 2

Total self-paid 3

Have received education about HF? Please

detail who, when, where

Appendices 253

APPENDIX 19: CHARLSON COMORBIDITY INDEX

Charlson Comorbidity Index

Aka: Charlson Comorbidity Index, Comorbidity-Adjusted Life Expectancy

1. Indication

Assess whether a patient will live long enough to benefit from a specific screening measure or medical

intervention

2. Scoring:

Comorbidity Component (Apply 1 point to each unless otherwise noted)

1. Myocardial Infarction

2. Congestive Heart Failure

3. Peripheral Vascular Disease

4. Cerebrovascular Disease

5. Dementia

6. COPD

7. Connective Tissue Disease

8. Peptic Ulcer Disease

9. Diabetes Mellitus (1 point uncomplicated, 2 points if end-organ damage)

10. Moderate to Severe Chronic Kidney Disease (2 points)

11.Hemiplegia (2 points)

12. Leukemia (2 points)

13. Malignant Lymphoma (2 points)

14. Solid Tumor (2 points, 6 points if metastatic)

15. Liver Disease (1 point mild, 3 points if moderate to severe)

16. AIDS (6 points)

3. Scoring: Age

Age < 40 years: 0 points

Age 41-50 years: 1 points




254 Appendices

4. Interpretation

Calculate Charlson Score or Index (i)

Add Comorbidity score to age score

Total denoted as'i' below

Calculate Charlson Probablity (10 year mortality)

Calculate Y = e^(i * 0.9)

Calculate Z = 0.983^Y111

where Z is the 10 year survival

Appendices 255

APPENDIX 20: THE VIETNAMESE VERSION OF THE SCHFI

BỘ CÂU HỎI “CÁC CHỈ SỐ TỰ CHĂM SÓC SUY TIM”

Các câu trả lời của ông/bà đều được giữ bí mật.

Dựa vào những cảm nhận của ông/bà trong tháng vừa rồi hoặc từ lần nói chuyện trước giữa chúng ta, hãy

trả lời những câu hỏi sau:

Phần A:

Dưới đây là những hướng dẫn phổ biến cho người bị suy tim. Ông/bà thực hiện những điều này ở mức độ

thường xuyên như thế nào?

Không bao

giờ hoặc

hiếm khi

Thỉnh

thoảng

Thường

xuyên

Luôn luôn

hoặc hàng

ngày

1. Tự kiểm tra cân nặng của ông/bà? 1 2 3 4

2. Kiểm tra các mắt cá chân có sưng không? 1 2 3 4

3. Cố gắng tránh bị ốm (ví dụ, tiêm phòng

cúm, tránh gặp người ốm)

1 2 3 4

4. Có vận động thể chất không, ví dụ: đi lại,

quét nhà?

1 2 3 4

5. Giữ đúng lịch hẹn gặp/lịch tái khám với

bác sỹ hoặc điều dưỡng?

1 2 3 4

6. Ăn một chế độ ít muối? 1 2 3 4

7. Tập thể dục 30 phút? 1 2 3 4

8. Quên uống một loại trong số các loại thuốc

ông/bà được kê?

1 2 3 4

9. Yêu cầu món ăn ít muối khi đi ăn hàng

hoặc thăm nhà người khác?

1 2 3 4

10. Sử dụng một phương pháp (ví dụ, hộp

đựng thuốc, giấy ghi nhớ) để nhắc ông/bà

uống các loại thuốc?

1 2 3 4

Phần B:

Nhiều người bệnh có các triệu chứng do bị suy tim. Khó thở và phù mắt cá chân là những triệu chứng

thường gặp của suy tim.

Trong tháng vừa qua, ông/bà có bị khó thở hoặc phù mắt cá chân lần nào không? Khoanh tròn một câu trả

lời.

Không Có

256 Appendices

11. Nếu trong tháng vừa qua ông bà bị khó thở hoặc phù mắt cá chân (khoanh tròn một số)

Tôi không

có các triệu

chứng này

Tôi không

nhận ra

Tôi

nhận ra

muộn

Tôi

nhận

ra khá

sớm

Tôi

nhận

ra sớm

Tôi nhận ra

rất sớm

Ông/bà có sớm nhận ra đó là triệu

chứng của suy tim Bỏ qua 0 1 2 3 4

Dưới đây là một số lời khuyên cho người bị suy tim. Nếu ông/bà có khó thở hoặc sưng mắt cá chân,

ông/bà có thử một trong những lời khuyên này không?

(khoanh một chữ số cho mỗi lời khuyên)

Không Có lẽ

có

Có Chắc chắn

có

12. Giảm muối trong chế độ ăn của ông/bà 1 2 3 4

13. Giảm lượng dịch ông/bà uống vào 1 2 3 4

14. Uống thêm một viên thuốc lợi tiểu 1 2 3 4

15. Gọi cho bác sỹ hoặc điều dưỡng để được hướng

dẫn

1 2 3 4

16. Nghĩ lại một lời khuyên mà ông/bà đã thực hiện theo vào lần trước ông/bà bị khó thở hoặc sưng

mắt cá chân (khoanh tròn một số)

Tôi không

làm theo

một lời

khuyên nào

Không

chắc

chắn

Tương

đối chắc

chắn

Chắc

chắn

Rất chắc

chắn

Ông/bà có chắc chắn là lời khuyên đó hiệu quả hay

không? 0 1 2 3 4

Phần C:

Nói chung, ông/bà tự tin ở mức độ nào rằng ông/bà có thể:

Không tự

tin

Tương đối

tự tin

Rất tự

tin

Cực kỳ

tự tin

17. Giữ cho ông/bà không có các triệu chứng của

suy tim?

1 2 3 4

18. Tuân theo các khuyến cáo điều trị ông/bà được

hướng dẫn?

1 2 3 4

Appendices 257

19. Nhận thức được tầm quan trọng của các triệu

chứng ông/bà có?

1 2 3 4

20. Nhận ra những thay đổi về sức khỏe của ông/bà

nếu nó xuất hiện?

1 2 3 4

21. Làm gì đó giúp giảm bớt các triệu chứng của

ông/bà?

1 2 3 4

22. Đánh giá một cách chữa trị có hiệu quả như thế

nào?

1 2 3 4

258 Appendices

APPENDIX 21: ETHICS APPROVAL FROM HANOI SCHOOL OF PUBLIC

HEALTH

Appendices 259

APPENDIX 22: QUT ETHICS APPROVAL FOR PHASE ONE AND PHASE

TWO

260 Appendices

Appendices 261

APPENDIX 23: QUT ETHICS APPROVAL FOR THE CRCT

262 Appendices

Appendices 263

APPENDIX 24: LETTER OF APPROVAL OF VIETNAM NATIONAL

HEART INSTITUTE

264 Appendices

APPENDIX 25: BACKWARD TRANSLATION OF THE SCHFI

SELF-CARE INDEX FOR PEOPLE WITH HEART FAILURE QUESTIONNAIRE

Your answers will be kept confidential.

Based on your feelings in the last month or since our last meeting, please answer the following questions:

PART A:

Followings are common instructions for people with heart failure. How routinely do you follow them?

Never or

rarely

Some-times Freque

ntly

Always or

daily

1. Check your weight? 1 2 3 4

2. Examine swelling in your ankles? 1 2 3 4

3. Try to avoid getting sick (eg: flu

vaccination, avoid meeting sick people)

1 2 3 4

4. Do physical exercise, eg: walking, doing

light chores?

1 2 3 4

5. Keep the appointments with a doctor or

nurse?

1 2 3 4

6. Eat a low-salt diet 1 2 3 4

7. Exercise for 30 minutes 1 2 3 4

8. Forget to take one of your prescribed

medicines

1 2 3 4

9. Ask low salt dishes in the restaurant or

visiting other people

1 2 3 4

10. Use a method (eg: pill container, notes) to

remind you to take medicines

1 2 3 4

PART B:

Many patients have symptoms due to heart failure. Trouble breathing and swollen ankles are common

symptoms of heart failure.

Did you have trouble breathing or swollen ankles last month? Please circle one answer.

0. No 1. Yes

11. If you had trouble breathing or swollen ankles last month (Please circle one number)

I did not

have these

I did not I recognised I realised I recognised I recognised

Appendices 265

symptoms recognise late quite early early very early

Did you

quickly

recognise it as

symptoms of

heart failure?

Skip 0 1 2 3 4

The following is some treatment advice for people with heart failure. If you have trouble breathing or

swollen ankles, would you try any of the following treatment advice?

(Please circle one number for each treatment advice)

No May be

yes

Yes Certainly yes

12. Reduce salt intake in your diet 1 2 3 4

13. Reduce the amount of fluid you take in (eg tea,

coffee, soup…)

1 2 3 4

14. Take an extra diuretic pill 1 2 3 4

15. Call your doctor or nurse for advice 1 2 3 4

16. Think about the advice you followed in the last time when you had trouble breathing or swollen

ankles (Please circle one number)

I did not

follow any

advice

Uncertai

nly

Somewhat

certainly

Certai

nly

Very

certainly

How sure were you that

advice worked or not? 0 1 2 3 4

PART C:

Generally, how confident are you that you can:

Unconfi

dent

Quite

confident

Very

confident

Extremely

confident

17. Keep you without symptoms of heart

failure? 1 2 3 4

18. Follow your treatment advice? 1 2 3 4

19. Be aware of the importance of the

symptoms you have? 1 2 3 4

20. Recognize changes in your health if 1 2 3 4

266 Appendices

they appear?

21. Do something to reduce your

symptoms? 1 2 3 4

22. Evaluate how well a treatment works? 1 2 3 4

Appendices 267

APPENDIX 26: ITEM-LEVEL CVIS OF THE SCHFI ITEMS

Item Relevancy Clarity Completeness Appropriateness

Item 1 1 1 1 1

Item 2 1 1 1 1

Item 3 0.625 0.75 0.75 0.75

Item 4 1 0.625 1 0.875

Item 5 1 1 1 1

Item 6 1 0.875 1 0.875

Item 7 0.875 1 0.875 1

Item 8 0.875 1 1 0.875

Item 9 1 1 0.875 0.875

Item 10 0.875 0.875 0.875 0.875

Item 11 1 1 1 0.875

Item 12 1 1 1 1

Item 13 1 1 1 1

Item 14 1 1 1 1

Item 15 1 1 1 0.875

Item 16 1 1 1 0.875

Item 17 0.875 0.875 0.875 0.875

Item 18 1 1 1 1

Item 19 1 0.875 1 1

Item 20 1 1 1 1

Item 21 1 1 1 1

Item 22 1 0.875 1 1

268 Appendices

APPENDIX 27: TEST OF NORMALITY

Variables Missing data

(%)

Skewness

(SE)

Kurtosis

(SE)

Shapiro-Wilk

p value

Age (years) 0 (0) -0.49 (0.2) 0.05 (0.4) 0.03

Length of stay (days) 18 (12.9) 1.7 (0.22) 3.6 (0.43) < 0.001

Weight (kg) 6 (4.3) 0.33 (0.21) -0.41 (0.42) 0.06

Height (cm) 3 (2.1) -0.32 (0.21) 0.59 (0.41) 0.06

Hb (g/l) 13 (9.3) -0.09 (0.21) 1.6 (0.43) 0.007

HbA1C (%) 97 (69.3) 4.5 (0.36) 24.7 (0.71) < 0.001

Creatinine (umol/l) 8 (5.7) 4.43 (0.21) 25.7 (0.42) < 0.001

Blood sugar (umol/l) 11 (7.9) 11.28 (0.21) 127.8 (0.42) < 0.001

Systolic BP (mmHg) 9 (6.4) 0.70 (0.21) 0.30 (0.42) < 0.001

Diastolic BP (mmHg) 9 (6.4) 0.19 (0.21) -0.09 (0.42) < 0.001

Pro-BNP (pmol/l) 21 (15) 1.95 (0.22) 3.65 (0.44) < 0.001

Ejection fraction (%) 39 (27.9) 0.24 (0.24) -0.95 (0.47) 0.006

No. of medications 8 (5.7) 1.05 (0.21) 2.01 (0.42) < 0.001

Comorbidity index 0 (0) 0.17 (0.20) -0.32 (0.41) < 0.001

Test of normality of outcomes measures (n=140)

Variables Missing data

(%)

Skewness

(SE)

Kurtosis

(SE)

Shapiro-

Wilk p value

DHFKS knowledge 1 0 (0) 0.11 (0.20) -0.31 (0.41) 0.01*

SCHFI Maintenance1 0 (0) -0.19 (0.20) -0.17 (0.41) 0.24

SCHFI Management1 40 (28.6) -0.13 (0.24) -0.15 (0.48) 0.13

SCHFI Confidence1 0 (0) 0.44 (0.20) -0.39 (0.41) 0.002*

DHFKS Knowledge 2 53 (37.9) -0.10 (0.26) -0.77 (0.51) 0.004*

SCHFI Maintenance2 53 (37.9) 0.09 (0.26) -0.78 (0.51) 0.11

SCHFI Management2 118 (84.3) 0.75 (0.49) 0.06 (0.95) 0.15

SCHFI Confidence2 53 (37.9) -0.26 (0.26) -0.59 (0.51) 0.01*

DHFKS Knowledge 3 34 (24.3) -0.24 (0.23) -0.69 (0.46) 0.004*

SCHFI Maintenance3 34 (24.3) -0.25 (0.23) -0.73 (0.46) 0.01*

SCHFI Management3 109 (77.9) 0.52 (0.42) -0.06 (0.82) 0.25

SCHFI Confidence3 34 (24.3) 0.23 (0.23) 0.28 (0.46) 0.04*

*p < 0.05 indicated variables were not normally distributed

Appendices 269

APPENDIX 28: HISTOGRAM, NORMAL Q-Q BLOTS AND BOX-WHISKER

PLOTS OF VARIABLES

270 Appendices

Appendices 271

272 Appendices

Appendices 273

274 Appendices

Appendices 275

276 Appendices

APPENDIX 29: CHARACTERISTICS OF PARTICIPANTS WHO DROPPED OUT

Characteristics Participants who stayed

N = 106

All missing participants

N = 34

P value

comparison

test a

Lost-to-follow up participants

N = 14

Age (years) mean (sd)

55.5±12.0 51.3±12.4 NS 50.6 ±13.9

Gender, n, %

Male 57 (53.8%) 18 (52.9%) NS 10 (71.4%)

Female 49 (46.2%) 16 (47%) 4 (28.6%)

Marital status, n, %

Single/ Divorce/ Widow 12 (11.3%) 6 (17.6%) NS 5 (35.7)

Married 94 (88.8%) 28 (82.4%) 9 (64.3)

Education, n, %

Lower high school 80 (75.5%) 26 (76.5%) NS 12 (85.7)

Upper high school 26 (24.5%) 8 (23.5%) 2 (14.3)

Occupation, n, %

Unemployed and retire 43 (40.6%) 10 (29.4%) NS 5 (35.7)

Unskilled job 46 (43.4%) 21 (61.8%) 9 (64.3)

Professional Job 17 (16.0%) 3 (8.8%) 0

Insurance cover, n, %

Appendices 277

100% reimbursed 28 (26.4%) 8 (23.5%) NS 3 (21.4)

Partly reimbursed 64 (60.4%) 22 (64.7%) 8 (57.1)

Self-paid 14 (13.2%) 4 (11.8%) 3 (21.4)

Medication (mean, SD) 6.0 ±1.7 6.2±2.7 NS 6.9 ±3.3

Time since HF diagnosis, n, %

≤ 3 months 22 (20.8%) 9 (26.5%) NS 4 (28.6)

≤ 1 years 25 (23.6%) 9 (26.5%) 5 (35.7)

1-5 years 33 (31.1%) 10 (29.4%) 4 (28.6)

≥5 years 26 (24.5%) 6 (17.6%) 1 (7.1)

NYHA, n, %

II 37 (34.9%) 12 (35.3%) NS 6 (42.9)

III 61 (57.5%) 17 (50%) 7 (50)

IV 8 (7.5%) 5 (14.7%) 1 (7.1)

Comorbidity, n, %

Low (1-2) 24 (22.6%) 10 (29.4%) NS 6 (42.9)

Moderate (3-4)

49 (46.2%) 18 (52.9%) 5 (35.7)

High (>4) 33 (31.3%) 6 (17.6%) 3 (21.4)

Previous HF consultancy, n, %

Yes 58 (54.7%) 16 (47.1%) NS 8 (57.1)

No 48 (45/3%) 18 (52.9%) 6 (42.9)

Blood glucose (umol/l), median, IQR 5.5 (4.7 -7.6) 5.9 (5.0 – 7.0) NS 6 (4.9-8.6)

278 Appendices

Notes: a Comparison tests included Independent t-test, Independent sample Median Test, Chi-square test. NYHA: New York Heart Association, IQR: interquartile range; SD:

standard deviation, eGFR: glomerular filtration rate; Pro-BNP: Pro Beta-type natri uretic peptide, NS: non-significant p value. Using available data from all participants,

numerators and denominators varied.

HbA1C (%), mean, SD 5.9±1.5 5.6±0.5 NS 5.4 ±0.5

Creatinine (umol/l), median, IQR 98 (86 – 115) 101 (88 – 140) NS 99 (89.5 – 130)

eGFR(ml/min/1.73m2), mean, SD 64.6±20.7 60.8±18.9 NS 60.1 ±18.6

Hb (g/dl), mean, SD 135±18.5 131.9±22.6 NS 139 ±22.6

Pro-BNP (pmol/l) median, IQR 356 (70.2 – 822.5) 767.4 (216 – 1266) NS 543.4 (119.9 – 1213.3)

Ejection fraction (%), mean, SD 44.8±17.7 45.0±16.2 NS 43.7 ±19.2

Systolic pressure (mmHg) median, IQR 115 (110 – 130) 120 (100 – 130) NS 120 (110 – 130)

Diastolic pressure (mmHg) median, IQR 70 (60 – 80) 70 (60 – 80) NS 80 (60 -80)

HF knowledge, mean (SD) 8.7±2.0 8.5±2.4 NS 7.7 ±2.7

Self-care maintenance, mean (SD) 58.1±13.6 55.1±14 NS 55.5 ±14.1

Self-care management, mean (SD) 63.7±17.7 50.0±14.8 NS 60.0 ±15.6

Self-care confidence, mean (SD) 51.4±16.9 49.7±20.2 NS 52.4 ±23.9

Appendices 279

APPENDIX 30: ACCEPTANCE FOR PRESENTATION IN THE 1ST

INC

280 Appendices

APPENDIX 31: ACCEPTANCE FOR PRESENTATION IN THE 2015 JBI SYMPOSIUM

Appendices 281

APPENDIX 32: ACCEPTANCE FOR PRESENTATION IN THE 2016 ACNC

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