Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT04938661
- Status
- Completed
Conditions
- Acute Coronary Syndrome
- Acute Myocardial Infarction
- Heart Failure
- Percutaneous Coronary Intervention
- Stable Angina Pectoris
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Center-Based Cardiac Rehab — OTHER36 center-Based Cardiac Rehab Sessions
- mHealth — OTHERMobile Health Platform
- Home-Based Cardiac Rehab — OTHEREncouraged to exercise 3 times per week at home
Study Details
The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.
Key Dates
- Start date
- Jul 8, 2021
- Status verified
- Apr 2026
- Primary completion
- Apr 10, 2025
- Completion
- Jun 9, 2025
Study Design
- Enrollment
- 206 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Conventional Center-Based Cardiac Rehab (CON)Participants will be prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants have direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.
- Active Comparator: Conventional Center-Based Cardiac Rehab + mHealth (CON+)Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.
- Active Comparator: Home-Based Cardiac Rehab + mHealth (HOM+)Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.
Primary Outcome Measure
Change in Metabolic Equivalents of Task (METS) [ Time Frame: Baseline; 3 Months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | - |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
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