TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention

Study Overview
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Brief Summary
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Purpose of the trial: To evaluate the efficacy and safety of an intervention with SMS messages delivered by mobiles phones to improve adherence to cardiovascular medications in patients with atherosclerotic cardiovascular disease (ASCVD). Trial design: Two-parallel arm, single-blind, individually randomized controlled trial. Primary endpoint: Differences in changes (baseline minus 12 months) of: Low density lipoprotein cholesterol (LDL-C), Systolic Blood pressure and Heart Rate. Secondary endpoints: Differences in the changes (baseline minus 12-months) of: (i) adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire; and (ii) Urinary levels of 11 dh-TxB2, Rates of composite end-point of cardiovascular death and hospitalization due to cardiovascular disease up to 12 months, Rates of composite of non-cardiovascular death or hospitalizations due to non-cardiovascular disease up to 12 months and Adverse events: traffic accidents and injuries while reading SMS related to the trial. Duration of follow-up: 12 months Trial treatment: Intervention: The active treatment will consist of SMS that are aimed to modified behavioral factors associated with poor adherence to cardiovascular medications used in secondary prevention. The SMS will be delivered daily during the first month, increasing one day of interval for each week during the second month, and weekly thereafter until end of month 12th. In addition, they will receive SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly. Control: participants will only receive the SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly. Expected sample size, enrollment and expected number of centers: Sample size = 1600 Recruitment start date: March , 2017 Recruitment end date: September, 2017 Follow-up end date: March, 2018 Number of centers: 1 Statistical considerations: Intention to treat analysis The trial has >90% power (2 sided alpha= 0.05) to detect a reduction in LDL-C as low as 5.1 mg/dl, under the assumption that SMS will increase adherence to statins by 7%. The primary outcomes will be analyzed using ANCOVA. Partially Financed by COLCIENCIAS Code: 656672553352

Official Title
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TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Intervention SMS
* Behavioral: Control SMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old History of at least one of the following arterial occlusive events: acute coronary syndrome (unstable angina, acute myocardial infarction with or without ST elevation), stable angina, ischemic cerebrovascular disease, peripheral arterial disease or coronary revascularization (coronary artery bypass surgery (CABG) or percutaneous transluminal coronary angioplasty (PTCA). Own at least one mobile phone Ability to read and understand text messages (SMS) Intention to stay in the country of recruitment during the next 12 months Exclusion Criteria: Contraindication to take all cardiovascular medications used in secondary prevention. Participation in another randomized clinical trial that could interfere with adherence to treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention SMS<br>SMS aimed to improved adherence to medications used in secondary prevention of cardiovascular disease. Control SMS: SMS to thanks for participation in the trial and reminders of trial appointments. | Behavioral: Intervention SMS<br>* The active treatment will consist of SMS that are aimed to modified behavioral factors associated with poor adherence to cardiovascular medications used in secondary prevention. The SMS will be delivered daily during the first month, increasing one day of interval for each week during the second month , and weekly thereafter until end of month 12th. In addition, they will receive SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly.<br>|
| Placebo Comparator: Control SMS<br>SMS to thanks for participation in the trial and reminders of trial appointments. | Behavioral: Control SMS<br>* Participants will only receive the SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol | Low density lipoprotein cholesterol (LDL-C) mg/dl | Baseline and 12 months | 
| Differences in physiological variables depending on taking medications: Systolic Blood pressure | Systolic Blood pressure mmHg | Baseline and 12 months | 
| Differences in physiological variables depending on taking medications: Heart Rate | Heart Rate: Heartbeats per minute | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in self-reported adherence and recurrence of new cardiovascular and adverse events. | Adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire | Baseline and 12 months | 
| Urinary levels of 11 dh-TxB2 | Changes in Urinary levels of 11 dh-TxB2 pg/dl | Baseline and 12 months | 
| Death due to cardiovascular disease | Rate of death due to cardiovascular disease. | Baseline and 12 months | 
| Hospitalization due to cardiovascular disease | Rate of hospitalization due to cardiovascular disease. | Baseline and 12 months | 
| Death due to non-cardiovascular disease | Rate of death due to non-cardiovascular disease. | Baseline and 12 months | 
| Hospitalization due to non-cardiovascular disease | Rate of hospitalizations due to non-cardiovascular disease. | Baseline and 12 months | 
| Adverse events | Traffic accidents and injuries while reading SMS related to the trial. (Percentage) | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, mHealth