The Improving ATTENDance to Cardiac Rehabilitation Trial
Part of paid clinical trials in Detroit, Michigan.
- Sponsor
- Henry Ford Health System
- Study ID
- NCT03646760
- Status
- Completed
Conditions
- Angina Pectoris
- Cardiac Event
- Coronary Artery Disease
- Heart Failure
- Heart Valve Diseases
- Myocardial Infarction
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- HYCR — BEHAVIORALThis group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.
- CBCR — BEHAVIORALThis group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Study Details
The benefits of cardiac rehabilitation are well known. However, despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. This study will assess the efficacy of an innovative approach to CR delivery on attendance by combining both center-based and remote- or home-based CR sessions. The intervention group combines center-based CR and remote-/home-based CR and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine)
Key Dates
- Start date
- Mar 1, 2019
- Status verified
- Jul 2025
- Primary completion
- Dec 30, 2023
- Completion
- Dec 31, 2023
Study Design
- Enrollment
- 282 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Hybrid Cardiac Rehabilitation (HYCR)
- Active Comparator: Center Based cardiac Rehabilitation (CBCR)
Primary Outcome Measure
Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care). [ Time Frame: Baseline to 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | - |
Find similar trials in Detroit, MI
Related Studies
- Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRecruiting · Medtronic · Birmingham, Alabama
- Product Surveillance RegistryRecruiting · Medtronic · Birmingham, Alabama
- Cardiovascular Health Improvement ProjectRecruiting · University of Michigan · Ann Arbor, Michigan
- The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMRRecruiting · Cardiac Dimensions, Inc. · Gilbert, Arizona