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 — BEHAVIORAL
    This 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 — BEHAVIORAL
    This 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)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemDetroitMichigan48202-

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