- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098186
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santander
-
Floridablanca, Santander, Colombia, 683071
- Fundacion Cardiovascular de Colombia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Collaborators
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
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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