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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
63
BrightHeart® has two components: smartphone mobile based application and a human coach. It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
Stanford Healthcare
Stanford, California, United States
Medication adherence
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.
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence II
Proportion of participants with PDC ≥ 80% of the composite of the P2Y12 receptor antagonist and/or the statin
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence III
The PDC of each medication of the composite
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence IV
Proportion of participants with PDC ≥ 80% of each of the composite
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication adherence V
Mean time from discharge to first fill
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Medication persistence
proportion of patients with an active prescription at three months of a statin and P2Y12 inhibitor
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors I
Serum LDL-C at End of Study
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
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Cardiovascular risk factors II
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
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors III
Proportion of participants with HbA1c ≤ 7% at End of Study (only if diabetes mellitus was known at time of inclusion)
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors IV
Change in body weight from baseline to End of Study
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors V
Change in quality of life (measured by EQ-5D-3L14) from day 3-10 after discharge to End of Study
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VI
Change in patient activation (measured by PAM®1015) from day 3-10 after discharge to End of Study
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Cardiovascular risk factors VII
Physical activity at End of Study (measured by a physical acitivity questionnaire)
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Exploratory I: Rehospitalization
30-day rehospitalization for any reason
Time frame: Baseline through End of Study visit - approximately 90 days per participant.
Exploratory II: Cardiovascular outcomes
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
Time frame: Baseline through End of Study visit - approximately 90 days per participant.