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Active Not Recruiting
NCT06479876
Home-Based Cardiac Rehabilitation for Patients With Heart Failure
Conditions: Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Cardiovascular Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Vanderbilt University Medical Center
Location: Vanderbilt University Medical Center Nashville Tennessee
Summary
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 \ 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.
Source: ClinicalTrials.gov (NCT06479876). StuddyBuddy aggregates publicly available trial information.