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
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
n/a
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