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

June 4, 2020 updated by: Fundación Cardiovascular de Colombia

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

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

930

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Santander
      • Floridablanca, Santander, Colombia, 683071
        • Fundacion Cardiovascular de Colombia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention SMS
  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.
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.
Placebo Comparator: Control SMS
SMS to thanks for participation in the trial and reminders of trial appointments.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
Time Frame: Baseline and 12 months
Low density lipoprotein cholesterol (LDL-C) mg/dl
Baseline and 12 months
Differences in physiological variables depending on taking medications: Systolic Blood pressure
Time Frame: Baseline and 12 months
Systolic Blood pressure mmHg
Baseline and 12 months
Differences in physiological variables depending on taking medications: Heart Rate
Time Frame: Baseline and 12 months
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.
Time Frame: Baseline and 12 months
Adherence to cardiovascular medications used in secondary prevention measured by MARS-5 questionnaire
Baseline and 12 months
Urinary levels of 11 dh-TxB2
Time Frame: Baseline and 12 months
Changes in Urinary levels of 11 dh-TxB2 pg/dl
Baseline and 12 months
Death due to cardiovascular disease
Time Frame: Baseline and 12 months
Rate of death due to cardiovascular disease.
Baseline and 12 months
Hospitalization due to cardiovascular disease
Time Frame: Baseline and 12 months
Rate of hospitalization due to cardiovascular disease.
Baseline and 12 months
Death due to non-cardiovascular disease
Time Frame: Baseline and 12 months
Rate of death due to non-cardiovascular disease.
Baseline and 12 months
Hospitalization due to non-cardiovascular disease
Time Frame: Baseline and 12 months
Rate of hospitalizations due to non-cardiovascular disease.
Baseline and 12 months
Adverse events
Time Frame: Baseline and 12 months
Traffic accidents and injuries while reading SMS related to the trial. (Percentage)
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Juan P Casas, PhD, University College, London
  • Study Chair: Pablo A Perel, PhD, London School of Hygiene and Tropical Medicine
  • Study Director: Norma C Serrano, MsC, Fundacion Cardiovascular de Colombia
  • Principal Investigator: Anderson Bermon, MsC, Fundacion Cardiovascular de Colombia
  • Principal Investigator: Ana F Uribe, PhD, Universidad Pontificia Bolivariana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2017

Primary Completion (Actual)

August 19, 2019

Study Completion (Actual)

August 19, 2019

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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