Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Purpose
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.
Condition
- Valvular Heart Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants are randomized 1:1:1 to 3 groups.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Study coordinator performing the remote study visits will be blinded to the treatment group allocation until the participant has completed the study visit assessments.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Control |
Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living. |
|
|
Experimental HBCR hands-off |
Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets. |
|
|
Experimental HBCR interactive |
Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets. |
|
Recruiting Locations
Nashville, Tennessee 37203
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center