Smartphone GUIded MeDication AdherencE and Rehabilitation in Patients With Coronary Artery Disease

Not Applicable

Terminated

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome

• 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.

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-05
• Study Start: 2017-07-19
• Primary Completion: 2018-05-09
• Study Completion: 2018-08-17
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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