Impact of a Mobile Phone Text Messages Intervention on the Secondary Prevention of Cardiovascular Events After Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Escore of combined risk factor control
研究概览
简要总结
The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization. Text messages will include information about lifestyle modifications, medication adherence and cardiovascular risk factor control. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 4 pre-designed and semi-personalized text messages per week in addition to usual care for 6 months, while the control group will receive usual care.
详细描述
Purpose of the trial: The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization.
Trial design: Two-parallel arm, single-blind, block randomization.
Primary endpoint: The proportion achieving guideline levels of modifiable risk factors (LDL-C <70mg/dL, blood pressure <140/90 mm Hg, exercising regularly [≥5 d/wk × 30minutes of moderate exercise per session], nonsmoker status, and BMI <25). The investigators prespecified in the statistical analysis plan the efficacy variable of proportion achieving combined risk factor control (achieving risk factor targets in 4 or more of the 5 modifiable risk factors listed above) as a measure of a multiple risk factor effect.
Secondary endpoints: The plasma LDL-C level at 6 months, Level of physical activity, Blood Pressure, Medication adherence measured via Morisky scale, Proportion of non-smokers, Body mass index (BMI), Rates death and hospitalization up to 6 months.
Duration of follow-up: 6 months
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
- Single (Investigator)
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
- •Consecutive patients who have been hospitalized at the UFMG's University Hospital with primary or secondary diagnosis of Acute Coronary Syndrome and are discharged for outpatient follow-up;
- •Age ≥ 18 years, of both sexes;
- •Patients who are able to receive text messages by their own mobile phone.
排除标准
- •Refusal or inability to sign the Informed Consent.
- •Complete illiteracy.
研究组 & 干预措施
Experimental
Automated semi-personalized mobile phone text message-based intervention for secondary prevention plus usual care.
干预措施: Mobile phone text message (Behavioral)
No Intervention
Usual Care
结局指标
主要结局
Escore of combined risk factor control
时间窗: 6 months
The proportion achieving guideline levels of modifiable risk factors (LDL-C \<77mg/dL, blood pressure \<140/90 mm Hg, exercising regularly \[≥5 d/wk × 30minutes of moderate exercise per session\], nonsmoker status, and BMI \<25). We prespecified in the statistical analysis plan the efficacy variable of proportion achieving combined risk factor control (achieving risk factor targets in 4 or more of the 5 modifiable risk factors listed above) as a measure of a multiple risk factor effect
次要结局
- Proportion of non-smokers(6 months)
- Cardiovascular death(6 months)
- Death from any cause(6 months)
- Rehospitalization(6 months)
- Level of physical activity (measured via(6 months)
- Plasma LDL-C level(6 months)
- Blood Pressure(6 months)
- Body mass index (BMI)(6 months)
- Medication adherence (measured via "Medida de adesão aos tratamentos" - MAT)(6 months)
研究者
Antonio Luiz Pinho Ribeiro
Principal Investigator
Federal University of Minas Gerais