Cardiovascular Disease
Conditions
Keywords
Medication adherence, mHealth
Brief summary
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
Interventions
BEHAVIORALIntervention SMS
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.
BEHAVIORALControl SMS
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.
Sponsors
London School of Hygiene and Tropical Medicine
University College, London
Universidad Pontificia Bolivariana
Fundación Cardiovascular de Colombia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
TX2THeart-Colombia is a single-blind trial. The laboratory personnel in charge of measurement LDL-C and 11 dhTxB2 levels will not have access to treatment allocation and they will only have access to internal numerical ID variable. The laboratory results will be conducted once trial follow-up is completed, and results will be sent directly to the database manager, who will link the results to the existing database. The staff in charge of measurement blood-pressure and heart rate will not have access to information on treatment allocation. Measurement of blood pressure and heart rate will be the first activity to be conducted with participants in visits 1 and 3 to minimize any potential subconscious bias introduced as a consequence of patients inadvertently revealing to trial staff the treatment allocation. The only person who will have access to the information of the participants is the engineer in charge of the management of Dimagi-Commcare Plataform.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol | Baseline and 12 months | Low density lipoprotein cholesterol (LDL-C) mg/dl |
| Differences in physiological variables depending on taking medications: Systolic Blood pressure | Baseline and 12 months | Systolic Blood pressure mmHg |
| Differences in physiological variables depending on taking medications: Heart Rate | Baseline and 12 months | Heart Rate: Heartbeats per minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization due to cardiovascular disease | Baseline and 12 months | Rate of hospitalization due to cardiovascular disease. |
| Death due to non-cardiovascular disease | Baseline and 12 months | Rate of death due to non-cardiovascular disease. |
| Changes in self-reported adherence and recurrence of new cardiovascular and adverse events. | Baseline and 12 months | Adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire |
| Adverse events | Baseline and 12 months | Traffic accidents and injuries while reading SMS related to the trial. (Percentage) |
| Hospitalization due to non-cardiovascular disease | Baseline and 12 months | Rate of hospitalizations due to non-cardiovascular disease. |
| Urinary levels of 11 dh-TxB2 | Baseline and 12 months | Changes in Urinary levels of 11 dh-TxB2 pg/dl |
| Death due to cardiovascular disease | Baseline and 12 months | Rate of death due to cardiovascular disease. |
Countries
Colombia
Outcome results
None listed