Actively Recruiting
Home-Based Cardiac Rehabilitation for Patients With Heart Failure
Led by Vanderbilt University Medical Center · Updated on 2025-09-24
100
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.
CONDITIONS
Official Title
Home-Based Cardiac Rehabilitation for Patients With Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Stage C heart failure with NYHA Class I to III symptoms
- Recently discharged from a heart failure hospitalization OR
- Scheduled for a cardiology clinic visit with a prior heart failure hospitalization within the past 12 months OR
- Scheduled for a cardiology clinic visit with a Kansas City Cardiomyopathy Questionnaire score less than 75
- Receiving ongoing heart failure care at Vanderbilt University Medical Center, including at least one visit before the initial study phase
- Willing to continue participating in study visits and activities after initial phase
You will not qualify if you...
- Unable or unwilling to provide informed consent for the randomized trial
- Requires a wheelchair most of the time inside and outside the home
- Uses a walker or cane most of the time and scores 2 or lower on Mini-Cog or cannot perform 2 chair sit-to-stands independently or is at high fall risk
- History of falls in the last 6 months indicating balance or stability issues
- Age under 18 years
- Advanced heart failure (Stage D) or under evaluation for LVAD or transplant
- NYHA Class IV symptoms
- Congenital heart disease
- Pregnant
- Group 1 pulmonary hypertension
- Moderate to severe mitral or aortic valve disease
- Physical or neuropsychiatric issues preventing use of study tools or assessments (e.g., blindness, dementia)
- Planned surgery within 3 months
- Planned discharge to hospice, assisted living, or inpatient rehab (independent senior living allowed)
- Physician or study team deems participation unsafe
- Currently participating in another ongoing randomized trial
- Not adherent to wearing the actigraphy device during initial phase as required
- Unable to complete baseline study visit within 4 weeks after initial activity tracking phase
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
B
Bassim El-Sabawi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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