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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.
Verified March 2017 by Fundación Cardiovascular de Colombia
Sponsor:
ClinicalTrials.gov Identifier:
NCT03098186
First Posted: March 31, 2017
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
London School of Hygiene and Tropical Medicine
University College, London
Universidad Pontificia Bolivariana
Information provided by (Responsible Party):
Fundación Cardiovascular de Colombia
March 10, 2017
March 31, 2017
March 31, 2017
April 18, 2017
March 2018   (Final data collection date for primary outcome measure)
  • 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
Same as current
No Changes Posted
  • 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)
Same as current
Not Provided
Not Provided
 
TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention
TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention

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

Not Provided
Interventional
Not Provided
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
Cardiovascular Disease
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Intervention SMS
  • Placebo Comparator: Control SMS
    SMS to thanks for participation in the trial and reminders of trial appointments.
    Intervention: Behavioral: Control SMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
July 2019
March 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Anderson Bermon, MsC. +576399292 ext 344 andersonbermon@fcv.org
Contact: Diana I Cáceres, PhD +576399292 ext 344 dianacaceres@fcv.org
Colombia
 
 
NCT03098186
416
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Fundación Cardiovascular de Colombia
Fundación Cardiovascular de Colombia
  • London School of Hygiene and Tropical Medicine
  • University College, London
  • Universidad Pontificia Bolivariana
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
Fundación Cardiovascular de Colombia
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP