Designing a text messaging program to increase adherence ... › ... › 07 › 26 ›...

Designing a text messaging program to increase adherence to medication for

the secondary prevention of cardiovascular disease

Authors

Uribe-Rodríguez, Ana*; Pontifical Bolivarian University Bucaramanga sectional, Faculty of Psychology, [email protected]

*Corresponding author

Pérez-Rivero, Paula; Pontifical Bolivarian University Bucaramanga sectional, Faculty of Psychology, [email protected]

Free, Caroline; London School of Hygiene and Tropical Medicine, Public Health interventions Unit, [email protected]

Perel, Pablo; LSHTM, EPH, Department of Non-communicable Disease Epidemiology, [email protected]

Murray, Elizabeth; University College London, Research Department of Primary Care and Population Health, [email protected]

Serrano Díaz, Norma; Fundación Cardiovascular de Colombia, Direction of Research, [email protected]

Horne, Robert; Director, Centre for Behavioural Medicine UCL School of Pharmacy, University College London, [email protected]

Atkins, Louise; University College London Research Department of Epidemiology and Public Health, [email protected]

Casas, Juan Pablo; Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, Massachusetts, USA, [email protected]

Bermon Angarita, Anderson; Fundación Cardiovascular de Colombia, Research Department, [email protected]

Abstract

Background: Cardiovascular medication for secondary prevention has been

shown to be effective. However, cardiovascular patients have poor medication

All rights reserved. No reuse allowed without permission. certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.

The copyright holder for this preprint (which was notthis version posted July 26, 2019. .https://doi.org/10.1101/19002683doi: medRxiv preprint

https://doi.org/10.1101/19002683

adherence, the consequences of which include premature death, recurrence risk,

hospitalization, and high financial cost for the healthcare system. Behavioral

interventions based on text messaging technology are a promising strategy to

improving adherence in medications. In low-middle income settings there is no

high-quality evidence of a behavioral program delivered by SMS; hence we

describe the development, message content, and the program design of the

intervention for improving adherence to cardiovascular medication.

Methods: We used the model reported by Abroms and colleagues’ for developing

and evaluating text messages-based interventions. This model describes a

process in which the intervention created is based on theory and evidence, the

target audience is involved to ensure the intervention is engaging and useful, and

there is a focus on implementation from the outset.

Results: Our main result was the design of the program, which consisted of a

twelve-month structured intervention based on Transtheoretical Model of Behavior

Change. We wrote and validated clusters of texts messages targeting each stage

of the model. Each message went through an examination process including the

evaluation of former cardiovascular patients, experts and the team research

personnel. Another important result was an understanding of patients’ perceptions

of their experience of cardiovascular disease, barriers to accessing healthcare in

Colombia and the use of mobile technology for health.

Conclusions: An SMS intervention has the potential to be an acceptable and

effective way of improving adherence to medication in patients with cardiovascular



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disease. This paper describes the development and content of one such

intervention.

Keywords

Transtheoretical Model of Behavior Change

Cardiovascular diseases

Health Behavior

Medication Adherence

Text Messaging

Background

People with a history of cardiovascular events have a five times higher risk of new

events than people without no such history [1].Secondary prevention medications

(anti-platelet therapy, ACE inhibitors, beta-blockers and lipid lowering therapy) are

effective in reducing the risk of death and myocardial infarction in patients with

coronary heart disease. Meta-analysis of randomized controlled trials show that in

patients with existing coronary heart disease long term anti-platelet therapy

reduces major vascular events (MI, stroke or vascular mortality) by about a quarter

(OR 0.75 (95% CI 0.71-0.79); ACE inhibitors reduce cardiovascular mortality by

just under a fifth (RR 0.83, 95% CI 0.72 to 0.96); beta blockers reduce mortality by

almost a quarter (OR 0.77, 95% CI 0.69 to 0.85); and lipid lowering therapy

reduces coronary mortality by about a fifth (RR 0.79, 95% CI 0.75 to 0.83) [2].



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However, cardiovascular patients have poor medication adherence, the

consequences of which include premature death, increased risk of further

cardiovascular events, hospitalization, and high financial cost for the healthcare

system [3] [4] [5] [6] [7]. Therefore, strategies to improve medication adherence to

cardiovascular drugs must be a health priority [8] [6]. Since 2002, text messaging,

or short message service (SMS), has been part of m-health strategies to improve

health and change behavior [9]. Interventions using SMS have been shown to be

effective for smoking cessation, adherence to antiretroviral therapy [10], diabetes

self-management, weight loss, and physical activity [9]. As for cardiovascular

treatment, several randomized clinical trials (RCT) using text messages to improve

medical adherence in primary as well for secondary prevention have produced

promising, although not yet conclusive, results [11] [12]. Systematic reviews

conclude that existing RCTs have high risk of bias, so the evidence is uncertain,

and most were performed in high-income countries, so the evidence may not

generalize to low income countries [11].

The ongoing randomized clinical trial (RCT) “TXT2HEART COLOMBIA: Evaluation

of the Efficacy and Safety of Text Messages to Improve Adherence to

Cardiovascular Medications in Secondary Prevention” (https://clinicaltrials.gov),

involves an SMS-based intervention aimed at improving adherence to

cardiovascular medications amongst adults with history of arterial occlusive events

living in a metropolitan area of Colombia. This paper presents the design and

validation process of text messages developed for the RCT based on

Transtheoretical Model of Health Behavior Change (TTM) [13]. This model, also



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known as the Stages of Change, integrates cognitive, behavioral, and motivational

factors at different times in the behavior modification process. It has been recently

applied to develop interventions that use SMS to change behavior related to

nutrition [14], physical exercise [15] [16] and hypertension [17]. The publication of

this phase of the study will contribute to filling gaps in the literature identified by

Adler et al [11] by describing the development, message content, and the program

design of the intervention. It also fulfils the requirement to publish detailed

descriptions of interventions to avoid research waste [18] and allow a growing

evidence base about which interventions work for what reason [19].

Method

Our methodological approach is described in Fig. 1. We used the model reported

by Abroms and colleagues’ [20] for developing and evaluating text messages-

based interventions. This model describes a process in which the intervention

created is based on theory and evidence, the target audience is involved to ensure

the intervention is engaging and useful, and there is a focus on implementation

from the outset. Each step will be described in this section.

Figure 1. Process for text message intervention design



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Literature research: the first step consisted in conducting literature research related

to the target audience and behaviour change theories. A successful health

program needs evidence-based strategies [21] [22] and must focus on

understanding the health behavior that characterizes the population [20]. Literature

research aimed to: 1) understand the factors associated with low adherence to

cardiovascular medication and 2) identify the leading models and appropriate

techniques for modifying health behaviors related to medication adherence. We

performed literature research from February 2015 to June 2016 in the following

database: Scopus, Ovid, Medline, Cochrane Library, EBSCO, Pub-Med, Science

Direct and Google Scholar. The keyword terms were: Medication adherence,

Medication adherence and cardiovascular Disease, Social support and



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cardiovascular risk, Health models, and M-Health. We reviewed the following

behavior change models: The Theory of Reasoned Action [23], Social Learning

Theory [24], the Transtheoretical Model of Change [13], the Precede Model [25]

and the Behavior Change Wheel [26].

Objectives and techniques: As a result of this literature review, three main

objectives for the intervention were established based on the behavior change goal

and the theoretical aspects of the TTM: (1) raising awareness about medication

effectiveness, (2) promoting self-care, and (3) offering guidelines for behavioral

strategies to increase adherence (see Table 2). When the TTM was first

developed, Prochaska and DiClemente [13] proposed a relationship between the

perception of illness, or more appropriately the rise of awareness of illness, and the

intention to change behavior and the subsequent change.

Text message program design process: Our behavior change goal was to improve

medication adherence in secondary prevention for patients with history of occlusive

arterial disease. In the literature search we found several studies indicating the

importance of evaluating barriers that affect adherence to medications in

cardiovascular patients [5] [27] [28]. We carried out qualitative research to identify

barriers to adherence in our setting and compared our findings to the existing

literature.

We used focus group methodology to interview patients with a previous history of

cardiovascular events. Participant inclusion criteria were: male and female adults

(18 years and older), ownership of a mobile cell phone with an active line, ability to



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read text messages and to give informed consent, and at least a six-month history

of any of the following cardiovascular diagnoses: coronary artery disease (including

non-primary coronary revascularizations), ischemic stroke, and peripheral artery

disease or atherosclerotic aortic disease. These selection criteria mirrored the

eligibility criteria for the TXT2Heart trial. Recruitment focused on patients who had

an occlusive arterial disease event and been hospitalized at the Fundación

Cardiovascular FCV, which provided clinical evidence of the event as well easier

access to the patients. The inclusion criteria were narrowed to events occurring

between six months and five years prior to the study. Participants were randomly

selected from the FCV databases using SQL (Structured Query Language), with

specification of the date of the event (between July 2011 and July 2015), ICD 10

diagnosis, and medical procedure such as angioplasty, revascularization, and

other interventions for the cardiovascular diseases mentioned. After the patients

gave their consent, a trained physician reviewed the patients’ electronic clinical

histories to confirm the diagnoses and dates of the occlusive event.

Text Message Library: The text message designers worked as an interdisciplinary

team, which included an epidemiologist, a pharmacologist, a specialist nurse in

health and quality audits, and three psychologists. Each team member developed

messages according to the following recommendations: length up to 160

characters (including spaces), use of appropriate language, avoidance of

abbreviations and misspellings, and informal punctuation [20]. Most importantly, for

the messages content the team considerate the findings from the focus groups

(categories and subcategories) and TTM (Stages of Change). Once the messages



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were written, the interdisciplinary team held several discussion meetings to

evaluate and classify each text message, considering aspects such as message

pertinence, intention, and clarity.

The messages were classified as viable, editable or as messages to be discarded.

Those identified as editable were rewritten, and some were also eliminated. Then,

the messages were organized using a matrix and classified according to the

categories and subcategories related to the barriers to adherence that were

identified in the literature and the focus groups. This helped to visualize how many

text messages corresponded to each category and subcategory, and to develop

new ones in order to have at least 12 messages in each category.

Expert validation: The text messages were submitted for evaluation by 13 experts.

The panel consisted of several different types of health professionals, including

psychologists (clinical, psychometric, and general), nutritionists, nurses

(practitioner, administrative, and researcher) and physicians (general practitioner,

cardiologist, interventional cardiologist, and with expertise in prevention and

health promotion). The experts were selected through convenience sampling and

the inclusion criteria were knowledge of the topic (cardiovascular disease for

physicians and behavior change for psychologists), research experience, and

test/trial validation expertise. These professionals were invited to participate

through a letter that explained the purpose of the validation. After accepting, they

received two documents: (1) instructions for validating the text messages, which

included descriptions of the categories, stages of the TTM, and aspects to be

evaluated (clarity, coherence, and relevance), and (2) an Excel template containing



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the text messages, the categories and subcategories, aspects to be evaluated, and

an additional space to record observations. The psychologists participating as

experts also evaluated the coherence between the SMS and the TTM of change.

All the judges evaluated the messages for clarity, coherence, and relevance on a

scale of 1 to 4, with 4 as the best score. An average score of 3.7 to 4 for the three

aspects and a Kendall's W of .85 or higher were indicators of strong agreement

among the judges.

Pretesting and revising the text messaging program: the third step included

feedback from prospective users about messages presented to them face to face,

international researchers’ opinions, and finally a test for the deliverability of

messages to cell phones. To obtain feedback form users, the participants from

previous focus groups were invited to attend a new focus group and to evaluate the

text messages. A total of 9 cardiovascular patients attended the meeting. The

focus group was facilitated by a psychologist and had four observers (one

physician, one nurse, and two psychologists). Participants were asked to evaluate

clarity, coherence (according to the categories), and the importance and relevance

of the messages. The final messages were presented to international experts in

the development of messaging interventions for comments. Lastly, a test was

conducted to assess the delivery of the text messages program using the

CommCare and Telerivet platforms. To this end, some of the text messages were

sent to the research team’s cell phones.

Results



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This section describes the results from the different steps presented in the

Methods section.

Literature Search. The World Health Organization [29], listed five dimensions that

affect treatment adherence: social and economic factors; health care and systems-

related factors; condition related factors; therapy related factors; and patient

related factors. The literature consistently shows that treatment adherence in

cardiovascular patients is poor [3] [4] [5] [6] [7]. Authors describe the non-

adherence of cardiovascular medication as a global threat [6] and as the major

obstacle to the treatment success [3]. Poor adherence to medication appears to be

only minimally related to the class of drugs taken or their side effects [4]; however,

misinformation, lack of knowledge about, or awareness of, cardiovascular disease

is an important barrier to treatment adherence [30] [7] [31].The asymptomatic

nature of many cardiovascular diseases, as well, may be related to poor adherence

to prescribed medication [23] [5]. As expected, difficulties with insurance coverage

are associated with poorer cardiovascular health [32] while perceived social

support can be related to better adherence [5].

In Latin America a study identified that lack of awareness of guidelines and

knowledge about preventing cardiovascular disease, communication problems

within health teams and lack of motivation were barriers to treatment adherence.

Particularly in Colombia, studies with cardiovascular patients’ show that most

participants are at risk of non-adherence [33].



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Focus groups: Forty cardiovascular outpatients were approached and invited to

the focus groups. Participants ranged in age from 25 to 80 years and most were

male. Data from participants were coded into the categories and subcategories

described in Table 1.

Table 1. Categories and subcategories.

Category Concept Sub-category Patient’s Quotes

1. Disease

perception

Patient opinions, ideas,

feelings and experiences

related to the disease

1.1. Experience with cardiovascular

disease

“I feel my body is not the

same […] although,

doctors and nurses seem

happy with my prognosis I

do not share their

enthusiasm”

1.2. Impact of the disease (gains and

losses since diagnosis)

1.3. Perceived severity of the disease

1.4. Self-care or behavioral mechanisms

2. Medication

intake

Patient behavior in terms of

medication intake according

to the recommendations

given by a healthcare

provider.

2.1. Knowledge of treatment “…they gave me some pills

that I do not even know what

they're for, I am no sure the

medications even work

2.2. Importance and significance of taking

medication

2.3. Experiences with medication intake

3. Perception

of the health

system

Patient perception of the

provision of care given by

health professionals,

primarily appointment

scheduling / control and

delivery of medications.

3.1. With regard to physicians and medical

team

“Insurance is a disaster, they

give you the appointment when

they want…” 3.2. With regard to health appointments

3.3. With regard to pharmacy

3.4. With regard to access to medicines,

use of legal resources for provision of

medications and / or procedures

4. Supportive

networks for

medical

treatment

Identifiable social

relationships surrounding

the individual that allow him

or her to receive emotional

support.

4.1. Most important sources of support for

diagnosis and / or disease (family,

NGOs, health workers, others)

“You are alone in this, so it is

very difficult […], here, you

are on your own”

4.2. Importance of support for self-care

4.3. Other support

5. Use and

appropriation

The patient has an active

role in giving meaning to a

5.1. Use of mobile phone “well you can use your cell

phone to remember taking 5.2. Benefits of using mobile phone



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Objectives and Techniques: Three main objectives for the intervention were

established based on the behavior change goal and the theoretical aspects of the

TTM: (1) raising awareness about medication effectiveness, (2) promoting self-

care, and (3) offering guidelines for behavioral strategies to increase adherence

(see Table 2). When the TTM was first developed, Prochaska and DiClemente [13]

proposed a relationship between the perception of illness, or more appropriately

the rise of awareness of illness, and the intention to change behavior and the

subsequent change. During this course of action, people experience different

processes of change and progress through five stages: pre-contemplation,

contemplation, preparation, action, and maintenance. These stages represent the

temporal dimension of behavior change [34] and a shift from intention to action.

The model includes at least ten processes of change (consciousness raising,

dramatic relief, environmental re-evaluation, social liberation, self-re-evaluation,

counter-conditioning, helping relationships, reinforcement management stimulus

control and self-liberation) that are actually cognitive and behavioral activities [34]

that facilitate moving through the stages (table 2).

Table 2. Stage of change, techniques and messages

of technology* certain experience. 5.3. Mobile phone as a useful tool for

treatment (m-Health)

medications”

Stage of Objectives SMS (Spanish) SMS



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Program design: The intervention was designed for SMS to be delivered over 12

months, based on the stages of the TTM. In the first month, we expect many

patients to be in the pre-contemplation phase so messages will be sent daily and

aim to raise awareness of future cardiovascular risk. During the second month, the

SMS will be sent every other day (four messages per week) and then once per

1 EPS- Common name in Colombia for the different companies that manage health insurance

Change

Precontemplation Raise

awareness

Un tratamiento farmacológico

adecuado le podría ayudar a prevenir

la aparición de nuevos eventos

cardiovasculares

An adequate pharmacological

treatment could help prevent the

appearance of new cardiovascular

events

Contemplation Give

information and

promote

personal

reevaluation

Recuerde que el evento

cardiovascular requiere control y

cuidados de por vida

Remember that a cardiovascular event

requires lifelong control and care.

Preparation Promote self-

care

La EPS es responsable de

suministrarle los medicamentos. Exija

su derecho

The EPS1 is responsible for supplying

the medications. Claim your right.

Action Offer behavioral

guidelines

Si presenta dificultades para recordar

la toma de medicamentos pídale a

alguien que le ayude a recodarle

If you have trouble remembering to

take your medication, ask someone to

help you remember.

Maintenance Offer behavioral

guidelines

Procure no quedarse sin cobertura de

salud, los profesionales en salud

pueden darse información de

diferentes formas de vinculación

Make sure you do not lose your health

coverage. Health professionals can

give you information about different

types of enrollment.



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week during the remaining ten months. Thus between 80 and 90 SMS were

needed to complete the one-year intervention program. The CommCare platform

was selected as the mobile platform for collecting data and managing the

frequency and timing.

The SMS will be sent through Telerivet, an instant SMS platform for organizations

as a unidirectional messaging program. The program will not offer interaction with

the patients and the messages will not be tailored. If at any time the patients want

to withdrawal from the trial, they will have the option to reply with the word STOP.

The Abroms’ model recommends clearly identifying the source of the SMS and

associating it with the health program [20] . To follow this recommendation and to

make it easier for the participants to recognize the message as being part of the

study intervention, we designed a step in the randomized trial protocol for saving

the contact in the participant’s cell phone, with the name Proyecto Txt4/FCV (Txt4

Project/ FCV).

SMS Construction. A total of 415 messages were generated by the

interdisciplinary group. They classified 212 messages as viable, 116 messages as

editable messages and 87 messages to be discarded. The result of this stage was

a text message library of 343 SMS to be evaluated by the judges (see Figure 2).

The validation by experts resulted in a total of 133 messages that met the criteria

of agreement (at least an average of 3.7 for the three aspects and a Kendall's W of

.85 or higher among the judges).

Figure 2. Process to Construct Text Messages



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Pretesting

Of the 133 messages read by the 9 cardiovascular patients, 110 (83%) were rated

as clear, and 28 of those were scored as the most relevant to the patients.

Participants also commented on the wording and punctuation of the messages,

indicating that they were short and brief, with no technical terms. These 110

messages were presented to the international experts for final review and

recommendations. They also evaluated other factors, such as the sequence of the

SMS for future trials and the avoidance of repetitive information. A key

recommendation was to prioritize messages that referred to medication adherence.

Thus, 73 SMS were finally selected for use in the trial (see Table 3). This step also

included testing the program configuration. The SMS were successfully sent to and

received by the research team’s cell phones.

Table 3. Number of messages and distribution

Category

Stage of Change

Pre-

contemplation Preparation Contemplation Action Maintenance

Total per category

Disease perception 2 2 3 2 3 12 (16%)

Health system

perception 2 3 2 5 3 15 (21%)

Supportive networks 2 2 2 5 3 14 (19%)

Medication intake 7 5 7 7 6 32 (44%)

General total: 13

(18%)

12

(16%)

14

(19%)

19

(26%)

15

(21%)

73

(100%)

Final Revision



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The research team made a final evaluation. During this revision, additional

messages were created to prepare the program for the randomized trial, especially

for the control group. One welcome message was developed and 12 messages for

the control group. These were related to recognition and gratitude for participation

in the study. Thus, 13 messages were added, but were not related to the

intervention for behavior change. Figure 2 summarizes the results of the process.

Discussion

The objective of this paper is to present the development of an intervention

program aimed to increase medication adherence in cardiovascular patients, using

technology and a behavior change model. The process was guided by a mixed

methods approach that included focus groups with patients, an interdisciplinary

team to create the text messages and expert validation. Beginning with the

literature search, each step was informed by the findings of the previous one.

Strengths of the approach described include the focus on sustainable behavior

change. Hence, the text messages were not reminders for medication intake or

appointments, but an intervention to increase awareness and commitment to

medication taking. The use of theory (TTM) to inform the content and delivery

schedule of the text messages is a strength of this program design, as

interventions based on theory have been shown to be more effective than those

not using theory (ref), The use of the TTM resulted in a conceptualization of

change as a process rather than a one-time event and resulted in a 12-month



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intervention program with SMS reflecting movement through the stages of change.

While the participants are in the first’s stages, motivational and informative

interventions are relevant. Therefore, in the program design, the messages sent to

the cell phones during the beginning of the intervention, focused on these

areas. This action is common for text messaging programs during important

behavior change periods [20].As the participants move to subsequent stages, the

messages are related to decision making and assuming responsibility. In the action

stage, even though the frequency of SMS decreased, the stage has a greater

number of messages in comparison with the others, since it aims to develop the

adherence behavior. This variation in the frequency, especially decreasing the

number of SMS, has been shown to be more effective than a fixed frequency [35].

Another strength of the development strategy was that the SMS were written by an

interdisciplinary team of medical specialists and psychologists. This ensured the

intervention reflected both clinical knowledge about cardiovascular diseases and

the effect of medication and psychological knowledge about cognitive and

motivational aspects of behavior change. For example, the physicians developed

the messages related to knowledge of the disease, treatment, and the importance

of taking medication, while the psychologists offered guidelines about the

appropriate way to communicate the information through an SMS, in accordance

with the TTM.

The focus groups with cardiovascular patients at the beginning and at the end of

the process were important to identify the target population’s perceptions of

important barriers to medication adherence and user test the SMS for clarity,



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acceptability and probable impact in the target population [36]. Expert validation

provided additional quality assurance.

Limitations

Limitations to this research must be considered. Due to the specific study site,

sampling, and sample size, generalizability of the results to other settings in

Colombia or outside Colombia may be limited. The qualitative approach to data

collection provided insight into subjective perceptions about messaging text as a

strategy to increase adherence medication in cardiovascular diseases patients, but

assessment of actual receptivity and uptake messages program and impact on

healthy behaviors requires further evaluation. Finally, because of the changing

nature of mobile technology and user expectations in m-health devices, the specific

recommendations reported here about a text messaging program for secondary

prevention in cardiovascular diseases may have time-limited relevance.

Nonetheless, if proven effective the message content could easily be delivered via

a range of digital media such as an app or social media messaging.

Conclusion

We demonstrated the feasibility of developing unidirectional messaging

intervention targeting adherence to medication for secondary prevention of heart

disease. Considering the long-term condition of the cardiovascular disease, a SMS

intervention can be also contemplated as an accompanying experience using

technology. It can be useful as a tool to offer support for the patient, with the

conviction it comes from expert, as an incentive from the health system.



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