Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease
- Conditions
- Coronary Artery DiseaseAcute Coronary Syndrome
- Interventions
- Other: BrightHeart®
- Registration Number
- NCT03207646
- Lead Sponsor
- Stanford University
- Brief Summary
This study evaluates a smartphone-based cardiac rehabilitation program in adults with coronary artery disease. Half of patients will participate in a smartphone-based cardiac rehabilitation program while the other half will receive standard-of-care.
- Detailed Description
Cardiac rehabilitation as a means to improve lifestyle-based risk factor modification, remains poorly prescribed and utilized, often due to the lack of access to programs, poor insurance coverage, cost, or patient or physician motivational factors. Low-cost solutions that can improve patient adherence to medications, risk factor reduction, and exercise could improve cardiovascular outcomes and cost-effectiveness compared to current care models.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description smartphone-based cardiac rehabilitation BrightHeart® The BrightHeart® mobile application is installed on the smartphone and a heart coach set up and guides the participant through a cardiac care program.
- Primary Outcome Measures
Name Time Method Medication adherence Baseline through End of Study visit - approximately 90 days per participant. The proportion of days coverd (PDC) expressed as a percentage but considered as a continuous variable of the composite of the prescribed P2Y12 receptor antagonist and/or the statin.
- Secondary Outcome Measures
Name Time Method Medication adherence III Baseline through End of Study visit - approximately 90 days per participant. The PDC of each medication of the composite
Medication adherence II Baseline through End of Study visit - approximately 90 days per participant. Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
Cardiovascular risk factors I Baseline through End of Study visit - approximately 90 days per participant. Serum LDL-C at End of Study
Cardiovascular risk factors II Baseline through End of Study visit - approximately 90 days per participant. Proportion of participants within target blood pressure (\<140/90 mmHg or \<130/80 mmHg for patients with diabetes mellitus or chronic kidney disease) at End of Study
Cardiovascular risk factors III Baseline through End of Study visit - approximately 90 days per participant. Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
Exploratory I: Rehospitalization Baseline through End of Study visit - approximately 90 days per participant. 30-day rehospitalization for any reason
Medication adherence IV Baseline through End of Study visit - approximately 90 days per participant. Proportion of participants with PDC ≥ 80% of each of the composite
Medication persistence Baseline through End of Study visit - approximately 90 days per participant. proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
Medication adherence V Baseline through End of Study visit - approximately 90 days per participant. Mean time from discharge to first fill
Cardiovascular risk factors IV Baseline through End of Study visit - approximately 90 days per participant. Change in body weight from baseline to End of Study
Cardiovascular risk factors VI Baseline through End of Study visit - approximately 90 days per participant. Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
Cardiovascular risk factors V Baseline through End of Study visit - approximately 90 days per participant. Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
Cardiovascular risk factors VII Baseline through End of Study visit - approximately 90 days per participant. Physical activity at End of Study (measured by a physical acitivity questionnaire)
Exploratory II: Cardiovascular outcomes Baseline through End of Study visit - approximately 90 days per participant. Major adverse cardiac events (MACE) defined as: Death, myocardial infarction, acute coronary syndrome, out of hospital cardiac arrest, stent thrombosis, repeat revascularization at 90 days
Trial Locations
- Locations (1)
Stanford Healthcare
🇺🇸Stanford, California, United States