NCT03098186

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

Completed NA Last updated 5 June 2020

What this trial tests

NA trial testing Intervention SMS in Cardiovascular Disease in 930 participants. Completed in 19 August 2019.

Timeline

18 April 2017

Primary endpoint
19 August 2019

19 August 2019

Quick facts

Lead sponsor	Fundación Cardiovascular de Colombia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	930
Start date	18 April 2017
Primary completion	19 August 2019
Estimated completion	19 August 2019
Sites	1 location across Colombia

Drugs / interventions tested

• Intervention SMS
• Control SMS

Conditions studied

• Cardiovascular Disease — all drugs for Cardiovascular Disease →

Sponsor

Fundación Cardiovascular de Colombia — full company profile →

Who can join

18 and older, any sex, with Cardiovascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and Safety of Text Messages Targeting Adherence to Cardiovascular Medications in Secondary Prevention: TXT2HEART Colombia Randomized Controlled Trial.
   Bermon A, Uribe AF, Pérez-Rivero PF, Prieto-Merino D, et al · · 2021 · cited 16× · PMID 34319247 · DOI 10.2196/25548
2. Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol.
   Bermon A, Uribe-Rodríguez AF, Pérez-Rivero PF, Prieto-Merino D, et al · · 2019 · cited 5× · PMID 31818831 · DOI 10.1136/bmjopen-2018-028017