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Randomized Controlled Trial
. 2021 Jul 28;9(7):e25548.
doi: 10.2196/25548.

Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial

Anderson Bermon  1   2 , Ana Fernanda Uribe  3 , Paula Fernanda Pérez-Rivero  3 , David Prieto-Merino  4   5 , Jose Federico Saaibi  6 , Federico Arturo Silva  7 , Diana Ivonne Canon  8 , Karol Melissa Castillo-Gonzalez  1 , Diana Isabel Cáceres-Rivera  9 , Elizabeth Guio  10 , Karen Janneth Meneses-Castillo  1 , Alberto Castillo-Meza  1 , Louise Atkins  11 , Robert Horne  12 , Elizabeth Murray  13 , Norma Cecilia Serrano  14 , Caroline Free  4 , Juan Pablo Casas  15   16 , Pablo Perel  17
Affiliations
Randomized Controlled Trial

Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial

Anderson Bermon et al. JMIR Mhealth Uhealth. .

Abstract

Background: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality worldwide, with a prevalence of approximately 100 million patients. There is evidence that antiplatelet agents and antihypertensive medications could reduce the risk of new vascular events in this population; however, treatment adherence is very low. An SMS text messaging intervention was recently developed based on behavior change techniques to increase adherence to pharmacological treatment among patients with a history of ASCVD.

Objective: This study aims to evaluate the efficacy and safety of an SMS text messaging intervention to improve adherence to cardiovascular medications in patients with ASCVD.

Methods: A randomized controlled clinical trial for patients with a prior diagnosis of cardiovascular events, such as acute myocardial infarction, unstable angina, cerebrovascular disease, or peripheral artery disease, in one center in Colombia was conducted. Patients randomized to the intervention arm were assigned to receive SMS text messages daily for the first 4 weeks, 5 SMS text messages on week 5, 3 SMS text messages each in weeks 6 and 7, and 1 SMS text message weekly from week 8 until week 52. In contrast, patients in the control arm received a monthly SMS text message reminding them of the next study appointment and the importance of the study, requesting information about changes in their phone number, and thanking them for participating in the study. The primary endpoint was the change in low-density lipoprotein cholesterol (LDL-C) levels, whereas the secondary endpoints were the changes in thromboxane B2 levels, heart rate, systolic and diastolic blood pressure, medication adherence, cardiac and noncardiac mortality, and hospitalization. Linear regression analyses and bivariate tests were performed.

Results: Of the 930 randomized patients, 805 (86.5%) completed follow-up and were analyzed for the primary endpoint. There was no evidence that the intervention changed the primary outcome (LDL-C levels; P=.41) or any of the secondary outcomes evaluated (all P>.05). There was also no evidence that the intervention was associated with adverse events.

Conclusions: In this study, there was no evidence that a behavior modification intervention delivered by SMS text messaging improved LDL-C levels, blood pressure levels, or adherence at 12 months. More research is needed to evaluate whether different SMS text messaging strategies, including personalized messages and different timings, are effective; future studies should include mixed methods to better understand why, for whom, and in which context (eg, health system or social environment) SMS text messaging interventions work (or not) to improve adherence in patients with ASCVD.

Trial registration: ClinicalTrials.gov NCT03098186; https://clinicaltrials.gov/ct2/show/NCT03098186.

International registered report identifier (irrid): RR2-10.1136/bmjopen-2018-028017.

Keywords: Colombia; cardiovascular disease; randomized controlled trial; secondary prevention; text messaging.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
CONSORT (Consolidated Standards of Reporting Trials) diagram.
Figure 2
Figure 2
Distribution of the MARS-5 scores at baseline. Graphs by Intervention. MARS-5: Medication Adherence Report Scale-5.
See this image and copyright information in PMC

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