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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098186
• Other study ID #: 416
• Status: Completed
• Phase: N/A
• Start date: April 18, 2017
• Est. completion date: August 19, 2019

Study information

• Verified date: June 2020
• Source: Fundación Cardiovascular de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 930
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	Fundación Cardiovascular de Colombia	Floridablanca	Santander

Sponsors (4)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia	London School of Hygiene and Tropical Medicine, Universidad Pontificia Bolivariana, University College, London

Country where clinical trial is conducted

Colombia, 

Outcome

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