TXT2HEART COLOMBIA: Evaluation of the Efficacy and Safety of Text Messages to Improve Adherence to Cardiovascular Medications in Secondary Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 930
- 试验地点
- 2
- 主要终点
- Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
TX2THeart-Colombia is a single-blind trial. The laboratory personnel in charge of measurement LDL-C and 11 dhTxB2 levels will not have access to treatment allocation and they will only have access to internal numerical ID variable. The laboratory results will be conducted once trial follow-up is completed, and results will be sent directly to the database manager, who will link the results to the existing database. The staff in charge of measurement blood-pressure and heart rate will not have access to information on treatment allocation. Measurement of blood pressure and heart rate will be the first activity to be conducted with participants in visits 1 and 3 to minimize any potential subconscious bias introduced as a consequence of patients inadvertently revealing to trial staff the treatment allocation. The only person who will have access to the information of the participants is the engineer in charge of the management of Dimagi-Commcare Plataform.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Contraindication to take all cardiovascular medications used in secondary prevention.
- •Participation in another randomized clinical trial that could interfere with adherence to treatment.
结局指标
主要结局
Differences in physiological variables depending on taking medications: low density lipoprotein cholesterol
时间窗: Baseline and 12 months
Low density lipoprotein cholesterol (LDL-C) mg/dl
Differences in physiological variables depending on taking medications: Systolic Blood pressure
时间窗: Baseline and 12 months
Systolic Blood pressure mmHg
Differences in physiological variables depending on taking medications: Heart Rate
时间窗: Baseline and 12 months
Heart Rate: Heartbeats per minute
次要结局
- Urinary levels of 11 dh-TxB2(Baseline and 12 months)
- Death due to cardiovascular disease(Baseline and 12 months)
- Hospitalization due to cardiovascular disease(Baseline and 12 months)
- Hospitalization due to non-cardiovascular disease(Baseline and 12 months)
- Adverse events(Baseline and 12 months)
- Changes in self-reported adherence and recurrence of new cardiovascular and adverse events.(Baseline and 12 months)
- Death due to non-cardiovascular disease(Baseline and 12 months)