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

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Fundación Cardiovascular de Colombia
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
University College, London
Universidad Pontificia Bolivariana
Information provided by (Responsible Party):
Fundación Cardiovascular de Colombia
ClinicalTrials.gov Identifier:
NCT03098186
First received: March 10, 2017
Last updated: March 30, 2017
Last verified: March 2017
  Purpose

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


Condition Intervention
Cardiovascular Disease Behavioral: Intervention SMS Behavioral: Control SMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, 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.
Primary Purpose: Supportive Care
Official Title: TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention

Further study details as provided by Fundación Cardiovascular de Colombia:

Primary Outcome Measures:
  • 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

  • Differences in physiological variables depending on taking medications: Systolic Blood pressure [ Time Frame: Baseline and 12 months ]
    Systolic Blood pressure mmHg

  • Differences in physiological variables depending on taking medications: Heart Rate [ Time Frame: Baseline and 12 months ]
    Heart Rate: Heartbeats per minute


Secondary Outcome Measures:
  • 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

  • Urinary levels of 11 dh-TxB2 [ Time Frame: Baseline and 12 months ]
    Changes in Urinary levels of 11 dh-TxB2 pg/dl

  • Death due to cardiovascular disease [ Time Frame: Baseline and 12 months ]
    Rate of death due to cardiovascular disease.

  • Hospitalization due to cardiovascular disease [ Time Frame: Baseline and 12 months ]
    Rate of hospitalization due to cardiovascular disease.

  • Death due to non-cardiovascular disease [ Time Frame: Baseline and 12 months ]
    Rate of death due to non-cardiovascular disease.

  • Hospitalization due to non-cardiovascular disease [ Time Frame: Baseline and 12 months ]
    Rate of hospitalizations due to non-cardiovascular disease.

  • Adverse events [ Time Frame: Baseline and 12 months ]
    Traffic accidents and injuries while reading SMS related to the trial. (Percentage)


Estimated Enrollment: 1600
Anticipated Study Start Date: April 18, 2017
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Intervention 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.
Placebo Comparator: Control SMS
SMS to thanks for participation in the trial and reminders of trial appointments.
Behavioral: Control 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03098186

Contacts
Contact: Anderson Bermon, MsC. +576399292 ext 344 andersonbermon@fcv.org
Contact: Diana I Cáceres, PhD +576399292 ext 344 dianacaceres@fcv.org

Locations
Colombia
Fundación Cardiovascular de Colombia Recruiting
Floridablanca, Santander, Colombia, 683071
Contact: Anderson Bermon, MsC    +576399292 ext 344    andersonbermon@fcv.org   
Principal Investigator: Juan P Casas, PhD         
Sub-Investigator: Pablo A Perel, PhD         
Sub-Investigator: Norma C Serrano, MsC         
Principal Investigator: Anderson Bermon, MsC         
Sub-Investigator: Ana F Uribe, PhD         
Sub-Investigator: David A Castro, MsC         
Sub-Investigator: Karol M Castillo, RN         
Sub-Investigator: Diana I Cáceres, PhD         
Sub-Investigator: David Prieto, PhD         
Sub-Investigator: Jose F Saaibi, MD         
Sub-Investigator: Federico A Silva, MD         
Sponsors and Collaborators
Fundación Cardiovascular de Colombia
London School of Hygiene and Tropical Medicine
University College, London
Universidad Pontificia Bolivariana
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 Fundación Cardiovascular de Colombia
Principal Investigator: Anderson Bermon, MsC Fundación Cardiovascular de Colombia
Principal Investigator: Ana F Uribe, PhD Universidad Pontificia Bolivariana
  More Information

Responsible Party: Fundación Cardiovascular de Colombia
ClinicalTrials.gov Identifier: NCT03098186     History of Changes
Other Study ID Numbers: 416
Study First Received: March 10, 2017
Last Updated: March 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundación Cardiovascular de Colombia:
Medication adherence
mHealth

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 21, 2017