Back to resultsHome-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions (HOMERUNHITTER)
Primary Purpose
Valvular Heart Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HBCR hands-off
HBCR interactive
Sponsored by
About this trial
This is an interventional treatment trial for Valvular Heart Disease focused on measuring cardiac rehabilitation, transcatheter heart valve intervention, cardiology, aortic stenosis, mitral regurgitation, tricuspid regurgitation
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
HBCR hands-off
HBCR interactive
Arm Description
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.
Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets.
Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Average daily moderate to vigorous active minutes
Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.
6 minute walk distance
The distance walked in 6 minutes.
Chair sit to stand time
The time taken to complete 5 chair rises.
5 meter gait speed
The speed of walking 5 meters (meters/second).
All-cause hospitalizations
Hospitalizations for any reason
All-cause death
Death for any cause
Heart-failure specific health status assessed by the KCCQ
Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ); (score range 0-100, higher is better health status)
Physical health status assessed by the PROMIS 10
Global physical health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20 with corresponding T score and SE, higher is better)
Mental health status assessed by the PROMIS 10
Global mental health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20 with corresponding T score and SE, higher is better)
Mood disturbance assessed by PHQ9
Patient health questionnaire 9 (PHQ9); (score range 1-27, higher score worse)
Patient goals progress score
A patient goals progress score (-3 to +3) will be determined for 5 domains and the scores combined for a global score from -15 to +15.
Basic mobility by AM-PAC
Basic mobility will be assessed with the Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form (Low Function); (raw score range 0-39 with corresponding T-score and SE, higher score is better)
Full Information
NCT ID
NCT06077201
First Posted
October 4, 2023
Last Updated
October 12, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
Medical University of South Carolina, University of Pittsburgh, Duke Clinical Research Institute, National Institute on Aging (NIA), University of Michigan, Pinnacle Health Cardiovascular Institute, The Cleveland Clinic, Chattanooga-Hamilton County Hospital Authority, University of Colorado, Denver, Piedmont Healthcare, Inova Fairfax Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06077201
Brief Title
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Acronym
HOMERUNHITTER
Official Title
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Medical University of South Carolina, University of Pittsburgh, Duke Clinical Research Institute, National Institute on Aging (NIA), University of Michigan, Pinnacle Health Cardiovascular Institute, The Cleveland Clinic, Chattanooga-Hamilton County Hospital Authority, University of Colorado, Denver, Piedmont Healthcare, Inova Fairfax Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
cardiac rehabilitation, transcatheter heart valve intervention, cardiology, aortic stenosis, mitral regurgitation, tricuspid regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized 1:1:1 to 3 groups.
Masking
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.
Allocation
Randomized
Enrollment
375 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
HBCR hands-off
Arm Type
Experimental
Arm Description
Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets.
Arm Title
HBCR interactive
Arm Type
Experimental
Arm Description
Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.
Intervention Type
Other
Intervention Name(s)
HBCR hands-off
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HBCR interactive
Intervention Description
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. Additionally, there are periodic video calls with an exercise physiologist.
Primary Outcome Measure Information:
Title
Probability of the hierarchical clinical event composite
Description
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.
Time Frame
Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Title
Average daily total activity counts
Description
Daily total activity counts are determined by a triaxial actigraphy device.
Time Frame
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 Outcome Measure Information:
Title
Average daily total activity counts
Description
Daily total activity counts are determined by a triaxial actigraphy device.
Time Frame
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.
Title
Average daily active minutes
Description
Daily active minutes are determined by a triaxial actigraphy device.
Time Frame
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.
Title
Average daily steps
Description
Daily steps are determined by a triaxial actigraphy device.
Time Frame
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.
Title
Average daily energy expenditure
Description
Daily energy expenditure is determined by a triaxial actigraphy device.
Time Frame
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.
Title
Average daily moderate to vigorous active minutes
Description
Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.
Time Frame
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.
Title
6 minute walk distance
Description
The distance walked in 6 minutes.
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
Chair sit to stand time
Description
The time taken to complete 5 chair rises.
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
5 meter gait speed
Description
The speed of walking 5 meters (meters/second).
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
All-cause hospitalizations
Description
Hospitalizations for any reason
Time Frame
Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Title
All-cause death
Description
Death for any cause
Time Frame
Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Title
Heart-failure specific health status assessed by the KCCQ
Description
Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ); (score range 0-100, higher is better health status)
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
Physical health status assessed by the PROMIS 10
Description
Global physical health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20 with corresponding T score and SE, higher is better)
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
Mental health status assessed by the PROMIS 10
Description
Global mental health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20 with corresponding T score and SE, higher is better)
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
Mood disturbance assessed by PHQ9
Description
Patient health questionnaire 9 (PHQ9); (score range 1-27, higher score worse)
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
Patient goals progress score
Description
A patient goals progress score (-3 to +3) will be determined for 5 domains and the scores combined for a global score from -15 to +15.
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
Title
Basic mobility by AM-PAC
Description
Basic mobility will be assessed with the Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form (Low Function); (raw score range 0-39 with corresponding T-score and SE, higher score is better)
Time Frame
The comparisons will be at 12, 24 and 52 weeks after randomization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
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