The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.
Treated with a transcatheter heart valve intervention (e.g., transcatheter aortic valve implantation [in the native valve or valve-in-valve], mitral transcatheter edge-to-edge repair, mitral valve-in-valve) of the aortic, mitral, or tricuspid valve done via transfemoral access
Unwilling or unable to provide informed consent
Not adherent to wearing the ActiGraph activity tracker during the roll-in phase for a minimum of 4 (out of 7) compliant days (worn >10 hours/day)
Planned participation in center based cardiac rehabilitation (CBCR)
Transcatheter heart valve intervention done via any route other than a transfemoral approach
Parallel
HBCR hands-off
Other interventionHome-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance.
HBCR interactive
Other interventionHome-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist.
Probability of the hierarchical clinical event composite
The hierarchical clinical event composite includes (in order of hierarchy): (1) all-cause death; (2) all-cause hospitalization; and (3) skilled nursing facility visits. To examine whether the intervention improves mortality, hospitalization, and SNF rates after THVIs, we will conduct Bayesian Markov longitudinal proportional odds model on weekly outcome measures. The pooled active treatment vs. control group comparison (primary comparison for the trial) will be estimated by contrasting the average of posterior probability that Y≥y of the two active treatment groups (hands-off HBCR and interactive HBCR) to the control group.
Average daily total activity counts
Daily total activity counts are determined by a triaxial actigraphy device.
Average daily total activity counts
Daily total activity counts are determined by a triaxial actigraphy device.
Average daily active minutes
Daily active minutes are determined by a triaxial actigraphy device.
Average daily steps
Daily steps are determined by a triaxial actigraphy device.
Average daily energy expenditure
Daily energy expenditure is determined by a triaxial actigraphy device.
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Vanderbilt University Medical Center
Lead sponsor
Medical University of South Carolina
Collaborator
University of Pittsburgh
Collaborator
Duke Clinical Research Institute
Collaborator
National Institute on Aging (NIA)
Collaborator
University of Michigan
Collaborator
The Cleveland Clinic
Collaborator
University of Colorado, Denver
Collaborator
Piedmont Healthcare
Collaborator
Wake Forest University Health Sciences
Collaborator
Morristown Medical Center
Collaborator
