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Home-Based Cardiac Rehabilitation for Patients With Heart Failure
NCT06479876 · Vanderbilt University Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial
About this study
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.
Eligibility criteria
Inclusion Criteria Roll-in Phase
1. Stage C HF (NYHA Class I-III) AND
1. Discharged from a HF hospitalization OR
2. Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
3. Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75
2. Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase
Randomized Controlled Trial (beyond roll-in phase)
1\. Willingness to continue and participate in the study visits and other study activities required for the RCT
Exclusion Criteria Roll-in Phase
1. Unwilling or unable to provide informed consent for participation in the RCT
2. Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
3. If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
4. History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
5. Age \< 18 years
6. Stage D HF (advanced HF under evaluation for LVAD or transplant)
7. NYHA class IV symptoms
8. Congenital heart disease
9. Pregnant
10. Group 1 pulmonary hypertension
11. Moderate-severe or severe (\> 3+) mitral or aortic valvular disease
12. Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
13. Planned surgery within 3 months
14. Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
15. Treating provider or study team physician indicates that participation in the RCT would be unsafe
16. Participation in any ongoing randomized trial that has not completed follow-up
Randomized Controlled Trial (beyond roll-in phase)
1. Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device \>9 hours/day for at least 1 day.
2. Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-08-05
Estimated completion: 2026-08
Last updated: 2025-09-24
Interventions
Other: HBCR
Primary outcomes
- • Average daily total activity counts (The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.)
Sponsor
Vanderbilt University Medical Center · other
Contacts & investigators
ContactBassim El-Sabawi, MD · contact · bassim.el-sabawi@vumc.org · 615-589-6076
InvestigatorBrian R Lindman, MD, MSCI · principal_investigator, Vanderbilt University Medical Center
All locations (1)
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States