Clinical trial NCT03098186: TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention
Official title: TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Medication adherence
mHealth
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: University College, London
name: Universidad Pontificia Bolivariana
First posted: 2017-03-31
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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


Eligibility 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.

Primary outcomes:
measure: Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
timeFrame: Baseline and 12 months
measure: Differences in physiological variables depending on taking medications: Systolic Blood pressure
timeFrame: Baseline and 12 months
measure: Differences in physiological variables depending on taking medications: Heart Rate
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.
timeFrame: Baseline and 12 months
measure: Urinary levels of 11 dh-TxB2
timeFrame: Baseline and 12 months
measure: Death due to cardiovascular disease
timeFrame: Baseline and 12 months
measure: Hospitalization due to cardiovascular disease
timeFrame: Baseline and 12 months
measure: Death due to non-cardiovascular disease
timeFrame: Baseline and 12 months
measure: Hospitalization due to non-cardiovascular disease
timeFrame: Baseline and 12 months
measure: Adverse events
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Floridablanca
country: Colombia
facility: Fundación Cardiovascular de Colombia
state: Santander
Study officials:
affiliation: University College, London
name: Juan P Casas, PhD
role: STUDY_CHAIR
affiliation: London School of Hygiene and Tropical Medicine
name: Pablo A Perel, PhD
role: STUDY_CHAIR
affiliation: Fundación Cardiovascular de Colombia
name: Norma C Serrano, MsC
role: STUDY_DIRECTOR
affiliation: Fundación Cardiovascular de Colombia
name: Anderson Bermon, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Pontificia Bolivariana
name: Ana F Uribe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.