Cardiac Care Solution for Coronary Disease Follow up (BAMA)

Peking University

Status: Completed

Conditions: ST Segment Elevation Myocardial Infarction; Unstable Angina; Non-ST Segment Elevation Myocardial Infarction

Treatments: Device: BAMA solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03565978

BAMA 0.1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

BAMA solution

Experimental group

Description:

This group will use BAMA solution. This is an digital solution used for cardiac post-discharge management. It is an application installed on a tablet. This arm will use this application and also have usual outpatient follow up.

Treatment:

Device: BAMA solution

Usual care

No Intervention group

Description:

Not using the application installed on the tablet. Usual outpatient follow up.