Evaluation of a Cardiac Care Solution for Post-Hospital Management in Primary and Secondary Care of Patients Diagnosed With Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ST Segment Elevation Myocardial Infarction
- Sponsor
- Peking University First Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Compliance for coronary heart disease secondary prevention at 12 months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Detailed Description
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). The study will be a two arm, randomized control study. The intervention group will use an application installed on a Pad besides standard outpatient follow up, while the control group will receive standard outpatient follow up.
Investigators
Yong Huo
Director, Department of Cardiology
Peking University First Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Compliance for coronary heart disease secondary prevention at 12 months
Time Frame: 12 months
Proportion of patients who use standardized secondary prevention medication according to current guidelines.
Secondary Outcomes
- Quality of life at the 6, 12 months (EQ-5D simple score)(6 and 12 months)
- Quality of life at the 6, 12 months (EQ-5D Visual Analog 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)