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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.

ABSTRACT: INTRODUCTION:Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients. METHODS AND ANALYSIS:The txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11-dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease. ETHICS AND DISSEMINATION:The study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population. TRIAL REGISTRATION NUMBER:NCT03098186.

SUBMITTER: Bermon A

PROVIDER: S-EPMC6924706 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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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.

Bermon Anderson A Uribe-Rodríguez Ana Fernanda AF Pérez-Rivero Paula Fernanda PF Prieto-Merino David D Cáceres Rivera Diana Isabel DI Guio Elizabeth E Atkins Louise L Horne Robert R Murray Elizabeth E Serrano Díaz Norma Cecilia NC Free Caroline C Perel Pablo P Casas Juan P JP

BMJ open 20191208 12

<h4>Introduction</h4>Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence ...[more]

PMID: 31818831

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Project description:BackgroundAtherosclerotic 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.ObjectiveThis study aims to evaluate the efficacy and safety of an SMS text messaging intervention to improve adherence to cardiovascular medications in patients with ASCVD.MethodsA 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.ResultsOf 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.ConclusionsIn 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 registrationClinicalTrials.gov NCT03098186; https://clinicaltrials.gov/ct2/show/NCT03098186.International registered report identifier (irrid)RR2-10.1136/bmjopen-2018-028017.

Project description:BACKGROUND:Identifying simple, low-cost and scalable means of supporting lifestyle change and medication adherence for patients following a cardiovascular (CV) event is important. OBJECTIVE:The TEXTMEDS (TEXT messages to improve MEDication adherence and Secondary prevention) study aims to investigate whether a cardiac education and support programme sent via mobile phone text message improves medication adherence and risk factor levels in patients following an acute coronary syndrome (ACS). STUDY DESIGN:A single-blind, multicentre, randomised clinical trial of 1400 patients after an ACS with 12 months follow-up. The intervention group will receive multiple weekly text messages that provide information, motivation, support to adhere to medications, quit smoking (if relevant) and recommendations for healthy diet and exercise. The primary endpoint is the percentage of patients who are adherent to cardioprotective medications and the key secondary outcomes are mean systolic blood pressure (BP) and low-density lipoprotein cholesterol. Secondary outcomes will also include total cholesterol, mean diastolic BP, the percentage of participants who are adherent to each cardioprotective medication class, the percentage of participants who achieve target levels of CV risk factors, major vascular events, hospital readmissions and all-cause mortality. The study will be augmented by formal economic and process evaluations to assess acceptability, utility and cost-effectiveness. SUMMARY:The study will provide multicentre randomised trial evidence of the effects of a text message-based programme on cardioprotective medication adherence and levels of CV risk factors. ETHICS AND DISSEMINATION:Primary ethics approval was received from Western Sydney Local Health District Human Research Ethics Committee (HREC2012/12/4.1 (3648) AU RED HREC/13/WMEAD/15). Results will be disseminated via peer-reviewed publications and presentations at international conferences. TRIAL REGISTRATION NUMBER:ACTRN12613000793718; Pre-results.

Project description:BACKGROUND:Medication adherence is important to improve the long-term outcomes after acute myocardial infarction (MI). We hypothesized that there is significant variation among US hospitals in terms of medication adherence after MI, and that patients treated at hospitals with higher medication adherence after MI will have better long-term cardiovascular outcomes. METHODS:We identified 19?704 Medicare patients discharged after acute MI from 347 US hospitals participating in the ACTION Registry-GWTG (Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With the Guidelines) from January 2, 2007, to October 1, 2010. Using linked Medicare Part D prescription filling data, medication adherence was defined as proportion of days covered >80% within 90 days after discharge. Cox proportional hazards modeling was used to compare 2-year major adverse cardiovascular events among hospitals with high, moderate, and low 90-day medication adherence. RESULTS:By 90 days after MI, overall rates of adherence to medications prescribed at discharge were 68% for ?-blockers, 63% for statins, 64% for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and 72% for thienopyridines. Adherence to these medications up to 90 days varied significantly among hospitals: ?-blockers (proportion of days covered >80%; 59% to 75%), statins (55% to 69%), thienopyridines (64% to 77%), and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (57% to 69%). Compared with hospitals in the lowest quartile of 90-day composite medication adherence, hospitals with the highest adherence had lower unadjusted and adjusted 2-year major adverse cardiovascular event risk (27.5% versus 35.3%; adjusted hazard ratio, 0.88; 95% confidence interval, 0.80-0.96). High-adherence hospitals also had lower adjusted rates of death or readmission (hazard ratio, 0.90; 95% confidence interval, 0.85-0.96), whereas there was no difference in mortality after adjustment. CONCLUSIONS:Use of secondary prevention medications after discharge varies significantly among US hospitals and is inversely associated with 2-year outcomes. Hospitals may improve medication adherence after discharge and patient outcomes through better coordination of care between inpatient and outpatient settings.

Project description:Introduction:The Alzheimer's Prevention Initiative Colombia Trial is a collaborative project involving the Neurosciences Group of Antioquia, Genentech/Roche, and the Banner Alzheimer's Institute, studying whether crenezumab can delay or prevent the clinical onset of Alzheimer's disease in cognitively unimpaired individuals who carry the PSEN1 E280A mutation. In an effort to optimize participant compliance and adherence and maintain interest in the trial for its duration, the Neurosciences Group of Antioquia developed an "Adherence/Retention Plan." This plan identifies potential barriers to trial adherence related to characteristics of the participants and study partners, protocol design, sponsors, investigators, environmental factors, and characteristics of this population in general and identifies potential solutions to these barriers. Methods:Neurosciences Group of Antioquia designed and implemented a number of strategies including a) a prescreening process that emphasized detailed and staged informed consent involving the participant and family and/or friends, b) a schedule of visits and assessments designed to minimize burden while achieving the trial's aims, c) appointment reminders, d) reimbursement for transportation and missed work, e) meals during study visits, f) birthday cards, g) quarterly newsletters, h) annual in-person feedback meetings, i) a supplemental health plan to participants, and j) a social plan to support family members. All the methods used in this plan were approved by local ethics committees. Results:By the end of the fourth year of the trial, participant retention was 94.0%, with most participants reporting that they felt "very satisfied" with their participation in the trial. Discussion:The Adherence/Retention Plan plays a crucial role in maintaining adherence and compliance needed to achieve the ambitious goals of the Alzheimer's Prevention Initiative-Colombia Autosomal Dominant Alzheimer's Disease Trial and may offer guideposts for other prevention trials.

Dataset Information

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

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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.

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