Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Compliance for coronary heart disease secondary prevention at 12 months
研究概览
简要总结
This is a prospective, randomized controlled trial. The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the secondary prevention of Coronary Artery Disease (CAD).
详细描述
The aim of the study is to evaluate the impacts of a cardiac post-discharge management solution in the population of cardiovascular (CVD) patients who were discharged from the hospital. The objectives include two parts:
Objective 1: Assess the feasibilities of using the solution by means of questionnaire.
Objective 2: Evaluate the impacts of the solution in the secondary prevention of Coronary Artery Disease (CAD).
Primary outcome: Compliance of coronary disease secondary prevention at 12 months.
Secondary outcome: Compliance of coronary disease secondary prevention at 6 months. Self-management behavior evaluation at the 6 and 12 months. Medication compliance at 6 and 12 months assessed by self-reporting questionnaire. Control rates of risk factors at the 6 and 12 months (serum LDL-C, blood pressure, fasting serum glucose); quality of life at the 6 and 12 months (EQ-5D, Seattle angina questionnaire); MACE (Major Adverse Cardiac Event) within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for cardiac reason, unplanned coronary revascularization).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with CAD, including either condition below: once diagnosed with myocardial infarction; or once accepted coronary artery interventional therapy;
- •Participants willing to use self-management solution and complying with follow-up plan;
- •At point of enrollment, the patients should be at least (>=18) years
- •Basic reading skills (Chinese)
排除标准
- •Participants that are enrolled in another interventional clinical trial
- •Participants who refuse to sign informed consent or withdraw for specific reasons recorded
- •Participants who have cognition disorder and unable to communicate normally
- •Participants who cannot master basic mobile technology skills to operate a mobile application after training
结局指标
主要结局
Compliance for coronary heart disease secondary prevention at 12 months
时间窗: 12 months
Proportion of patients who use standardized secondary prevention medication according to current guidelines.
次要结局
- Quality of life at the 6, 12 months (EQ-5D simple score)(6 and 12 months)
- Medication compliance at the 6, 12 months using the MMAS-8 (The eight-item Morisky Medication Adherence Scale)(6 and 12 months)
- Quality of life at the 6, 12 month (Seattle angina questionnaire)(6 and 12 months)
- MACE within 12 months (death, nonfatal myocardial infarction, nonfatal stroke, hospitalization with heart problem, unexpected revascularization)(12 months)
- Self-management behaviors evaluation at the 6, 12 months using a local questionnaire(6 and 12 months)
- Control rates of risk factors at the 6, 12 months(6 and 12 months)
- Quality of life at the 6, 12 months (EQ-5D Visual Analog Score)(6 and 12 months)
研究者
Yong Huo
Director, Department of Cardiology
Peking University First Hospital