RecruitingNot ApplicableNCT06077201

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

Sponsor

Vanderbilt University Medical Center

Enrollment

375 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

Valvular Heart Disease

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria13

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
Stroke during or immediately after the transcatheter heart valve intervention prior to randomization
Placement of a pacemaker within 6 weeks prior to the transcatheter heart valve intervention or after the transcatheter heart valve intervention and prior to randomization
Those who require a walker or who cannot get out of a chair/bed on their own and walk independently (use of a cane is acceptable)
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)
Planned surgery within 6 months after the heart valve intervention
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)
Treating provider or site PI indicates that participation in the study would be unsafe
Participation in any ongoing randomized trial that has not completed follow-up unless the sponsor of the other trial allows enrollment of the participant in this cardiac rehabilitation trial
Unable to complete the baseline study visit prior to 6 weeks after the transcatheter heart valve intervention

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Interventions

OTHERHBCR hands-off

Home-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.

OTHERHBCR interactive