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

Fundación Cardiovascular de Colombia

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: Control SMS; Behavioral: Intervention SMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03098186

416

Details and patient eligibility

About

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

Enrollment: 930 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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930 participants in 2 patient groups, including a placebo group

Intervention SMS

Active Comparator group

Description:

1. SMS aimed to improved adherence to medications used in secondary prevention of cardiovascular disease. 2. Control SMS: SMS to thanks for participation in the trial and reminders of trial appointments.

Treatment:

Behavioral: Intervention SMS

Control SMS

Placebo Comparator group

Description:

SMS to thanks for participation in the trial and reminders of trial appointments.

Treatment:

Behavioral: Control SMS