Clinical trial NCT06077201: Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Official title: Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Valvular Heart Disease
Keywords: cardiac rehabilitation
transcatheter heart valve intervention
cardiology
aortic stenosis
mitral regurgitation
tricuspid regurgitation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: University of Pittsburgh
name: Duke Clinical Research Institute
name: National Institute on Aging (NIA)
name: University of Michigan
name: The Cleveland Clinic
name: University of Colorado, Denver
name: Piedmont Healthcare
name: Inova Fairfax Hospital
name: Wake Forest University Health Sciences
name: Morristown Medical Center
First posted: 2023-10-11
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized 1:1:1 to 3 groups.
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Probability of the hierarchical clinical event composite
timeFrame: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
measure: Average daily total activity counts
timeFrame: 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.
Secondary outcomes:
measure: Average daily total activity counts
timeFrame: 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 secondary comparisons will be at 24 and 52 weeks after randomization.
measure: Average daily active minutes
timeFrame: 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 active minutes determined. The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Average daily steps
timeFrame: 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 steps determined. The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Average daily energy expenditure
timeFrame: 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 energy expenditure determined. The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Average daily moderate to vigorous active minutes
timeFrame: 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 moderate to vigorous active mins determined. The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: 6 minute walk distance
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Chair sit to stand time
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: 5 meter gait speed
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: All-cause hospitalizations
timeFrame: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
measure: All-cause death
timeFrame: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
measure: Heart-failure specific health status assessed by the KCCQ
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Physical health status assessed by the PROMIS 10
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Mental health status assessed by the PROMIS 10
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Mood disturbance assessed by PHQ9
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Patient goals progress score
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
measure: Basic mobility by AM-PAC
timeFrame: The comparisons will be at 12, 24 and 52 weeks after randomization.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Brian R. Lindman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: