Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol

Bermon, Anderson; Uribe-Rodríguez, Ana Fernanda; Pérez-Rivero, Paula Fernanda; Prieto‐Merino, David; Rivera, Diana Isabel Cáceres; Guío, Elizabeth; Atkins, Louise; Horne, Robert; Murray, Elizabeth; Díaz, Norma Cecilia Serrano; Free, Caroline; Perel, Pablo; Casas, Juan P.

doi:10.1136/bmjopen-2018-028017

Cited by 6 publications

(8 citation statements)

References 16 publications

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“…This study has many strengths. First, a thorough and detailed formative research was followed to develop a tailored behavioral modification intervention, which has been previously published [ 17 ] alongside the study protocol. Different outcomes have been collected, including self-reporting of adherence, validated adherence tools (ie, the MARS-5 has demonstrated acceptable reliability [internal and test-retest] and validity [criterion-related and construct validity]) [ 20 ], and proxy biological markers, and they were triangulated to evaluate adherence.…”

Section: Discussionmentioning

confidence: 99%

“…The full methodology of TXT2HEART Colombia has been previously published [ 17 ] and is summarized here. We report the following CONSORT (Consolidated Standards of Reporting Trials) recommendations [ 19 ].…”

Section: Methodsmentioning

confidence: 99%

“…If death or any major event or hospital admission occurred during the follow-up period, a hard copy of the death certificate from the patients’ relatives or case notes was requested on the 12-month follow-up visit. At the final follow-up, all biomarkers were processed simultaneously to avoid interference due to the reactive processing, and the simple handling protocol depicted in the protocol was followed [ 17 ]. At the initial appointment, we recorded at least three different phone numbers and a complete house address for each subject.…”

Section: Methodsmentioning

confidence: 99%

“…The original sample size of the study was 1600 participants, based on a 97% power to detect a 10% difference between arms in adherence. In the published protocol [ 17 ] of this trial, a table with power calculations under different assumptions was included. However, due to limited study funding, the final sample recruited was 930 participants, 805 (86.5%) of whom reported LDL-C at the final visit.…”

Section: Methodsmentioning

confidence: 99%

“…We developed an intervention (ie, SMS text message) following the recommendations of Abroms et al [ 16 ]: a review of the literature, conduct of qualitative studies, and use of formal theories and behavior change techniques (Transtheoretical Model of Behavior Change). Details of our intervention development have been described previously [ 17 , 18 ].…”

Section: Introductionmentioning

confidence: 99%

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

Bermon¹,

Uribe²,

Pérez-Rivero³

et al. 2021

JMIR Mhealth Uhealth

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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

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Bermon¹,

Uribe²,

Pérez-Rivero³

et al. 2021

JMIR Mhealth Uhealth

Self Cite

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Mobile phone text messaging for medication adherence in secondary prevention of cardiovascular disease

Redfern,

Tu,

Hyun

et al. 2024

Cochrane Database of Systematic Reviews

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Background Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for almost 18 million deaths annually. People with CVDs have a five times greater chance of suffering a recurrent cardiovascular event than people without known CVDs. Although drug interventions have been shown to be cost‐effective in reducing the risk of recurrent cardiovascular events, adherence to medication remains suboptimal. As a scalable and cost‐effective approach, mobile phone text messaging presents an opportunity to convey health information, deliver electronic reminders, and encourage behaviour change. However, it is uncertain whether text messaging can improve medication adherence and clinical outcomes. This is an update of a Cochrane review published in 2017. Objectives To evaluate the benefits and harms of mobile phone text messaging for improving medication adherence in people with CVDs compared to usual care. Search methods We searched CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We also checked the reference lists of all primary included studies and relevant systematic reviews and meta‐analyses. The date of the latest search was 30 August 2023. Selection criteria We included randomised controlled trials (RCTs) with participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim of improving adherence to medication for the secondary prevention of cardiovascular events. The comparator was usual care. We excluded cluster‐RCTs and quasi‐RCTs. Data collection and analysis We used standard Cochrane methods. Our primary outcomes were medication adherence, fatal cardiovascular events, non‐fatal cardiovascular events, and combined CVD event. Secondary outcomes were low‐density lipoprotein cholesterol for the effect of statins, blood pressure for antihypertensive drugs, heart rate for the effect of beta‐blockers, urinary 11‐dehydrothromboxane B2 for the antiplatelet effects of aspirin, adverse effects, and patient‐reported experience. We used GRADE to assess the certainty of the evidence for each outcome. Main results We included 18 RCTs involving a total of 8136 participants with CVDs. We identified 11 new studies in the review update and seven studies in the previous version of the review. Participants had various CVDs including acute coronary syndrome, coronary heart disease, stroke, myocardial infarction, and angina. All studies were conducted in middle‐ and high‐income countries, with no studies conducted in low‐income countries. The mean age of participants was 53 to 64 years. Participants were recruited from hospitals or cardiac rehabilitation facilities. Follow‐up ranged from one to 12 months. There was variation in the characteristics of text messages amongst studies (e.g. del...

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Technological advances within digital medicine

Altibi

Al’Aref

Khosravi

2021

Machine Learning in Cardiovascular Medicine

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Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol

Cited by 6 publications

References 16 publications

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

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

Mobile phone text messaging for medication adherence in secondary prevention of cardiovascular disease

Technological advances within digital medicine

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