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

NCT03098186 | Completed

• 1 other identifier: 416
• Study Type: interventional
• Target: 930
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Disease

Keywords

Medication adherence; mHealth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.

  Baseline and 12 months

• Urinary levels of 11 dh-TxB2

  Baseline and 12 months

• Death due to cardiovascular disease

  Baseline and 12 months

• Hospitalization due to cardiovascular disease

  Baseline and 12 months

• Death due to non-cardiovascular disease

  Baseline and 12 months

Study Arms (2)

Intervention SMS

ACTIVE COMPARATOR

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.

Behavioral: Intervention SMS

Control SMS

PLACEBO COMPARATOR

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

Behavioral: Control SMS

Interventions

Intervention SMS BEHAVIORAL

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.

Intervention SMS

Control SMS BEHAVIORAL

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.

Control SMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to take all cardiovascular medications used in secondary prevention.
• Participation in another randomized clinical trial that could interfere with adherence to treatment.

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• London School of Hygiene and Tropical Medicine: collaborator
• University College, London: collaborator
• Universidad Pontificia Bolivariana: collaborator

Study Sites (1)

Fundación Cardiovascular de Colombia

Floridablanca, Santander Department, 683071, Colombia

Location

Related Publications (2)

• Bermon A, Uribe AF, Perez-Rivero PF, Prieto-Merino D, Saaibi JF, Silva FA, Canon DI, Castillo-Gonzalez KM, Caceres-Rivera DI, Guio E, Meneses-Castillo KJ, Castillo-Meza A, Atkins L, Horne R, Murray E, Serrano NC, Free C, Casas JP, Perel P. Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Jul 28;9(7):e25548. doi: 10.2196/25548.

  PMID: 34319247 DERIVED

• Bermon A, Uribe-Rodriguez AF, Perez-Rivero PF, Prieto-Merino D, Caceres Rivera DI, Guio E, Atkins L, Horne R, Murray E, Serrano Diaz NC, Free C, Perel P, Casas JP. Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol. BMJ Open. 2019 Dec 8;9(12):e028017. doi: 10.1136/bmjopen-2018-028017.

  PMID: 31818831 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Juan P Casas, PhD

  University College, London

  STUDY CHAIR

• Pablo A Perel, PhD

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

• Norma C Serrano, MsC

  Fundación Cardiovascular de Colombia

  STUDY DIRECTOR

• Anderson Bermon, MsC

  Fundación Cardiovascular de Colombia

  PRINCIPAL INVESTIGATOR

• Ana F Uribe, PhD

  Universidad Pontificia Bolivariana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 31, 2017
• Study Start: April 18, 2017
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

CO (1)