Please select the eligibility criteria that correspond to the clinical trial below.
Title: TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention
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


Options:
A: 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.
B: Inclusion Criteria:

* ≥ 21 years of age,
* recent ACS or PCI within 1 week
* new antiplatelet (thienopyridine) prescription
* owns a smartphone

Exclusion Criteria:

* cognitive impairment
* lack of English proficiency/literacy
C: Inclusion Criteria:

* Post-MI hospital discharge within 2 weeks
* Enrolled in cardiac rehabilitation
* Prescribed anti-platelets, beta-blockers, ACE-inhibitors or ARBs, and/or statins on 1x/day regimen (for medication adherence trial)
* Prescribed exercise regimen (for exercise trial)
* Ability to read and write English
* Possession of a cell phone with text messaging capability

Exclusion Criteria:

* Age \< 18
* Incarcerated individuals
* Unable to read and write English
* Not in possession of a cell phone
* Patients prescribed medication regimen \> 1x/day
D: Inclusion Criteria: those who

* are aged more than 18 years old;
* have a history of stroke (including ischemic and hemorrhagic stroke) diagnosed at county hospital or higher-level facilities, and currently in a clinically stable condition and not receiving acute stroke treatment;
* will live in this village for at least nine months during the next 12 months;
* have a basic communication ability (i.e. can understand simple instructions);
* give participant informed consent and are willing to participate in the study.

Exclusion Criteria: those who

* are unable to get out of bed without maximum assistance;
* have serious life-threatening disease such as cancers;
* who have an expected life span of less than 6 months.

Answer: A