Valvular Heart DiseaseHOMERUNHITTERNCT06077201
Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions
A study testing HBCR hands-off and HBCR interactive in people with Valvular Heart Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- HBCR hands-off and HBCR interactive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 1 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caleb Hayes, MPH contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Anna Vatterott, MPH, 615-936-5798, anna.vatterott@vumc.org
Caleb Hayes, MPH, caleb.hayes@vumc.org
About this study
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.
- Conditions
- Valvular Heart Disease
- Being tested
- HBCR hands-off, HBCR interactive
- Keywords
- cardiac rehabilitation, transcatheter heart valve intervention, cardiology, aortic stenosis, mitral regurgitation, tricuspid regurgitation
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBCR hands-offOther
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.
HBCR interactiveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| HBCR hands-off | Experimental | Home-based cardiac rehabilitation with mobile application + AHA Life's Essential 8 sheets. Receives: Other: HBCR hands-off |
| HBCR interactive | Experimental | Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets. Receives: Other: HBCR interactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Average daily total activity counts
Daily total activity counts are determined by a triaxial actigraphy device.
Measured: 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 (16)
Average daily total activity counts
Daily total activity counts are determined by a triaxial actigraphy device.
Measured: 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.
Average daily active minutes
Daily active minutes are determined by a triaxial actigraphy device.
Measured: 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.
Average daily steps
Daily steps are determined by a triaxial actigraphy device.
Measured: 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.
Average daily energy expenditure
Daily energy expenditure is determined by a triaxial actigraphy device.
Measured: 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.
Average daily moderate to vigorous active minutes
Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.
Measured: 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.
6 minute walk distance
The distance walked in 6 minutes.
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
Chair sit to stand time
The time taken to complete 5 chair rises.
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
5 meter gait speed
The speed of walking 5 meters (meters/second).
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
All-cause hospitalizations
Hospitalizations for any reason
Measured: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
All-cause death
Death for any cause
Measured: Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
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)
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
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)
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
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)
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
Mood disturbance assessed by PHQ9
Patient health questionnaire 9 (PHQ9); (score range 1-27, higher score worse)
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
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.
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
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)
Measured: The comparisons will be at 12, 24 and 52 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start15 Dec 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1:1 to 3 groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, University of Pittsburgh, Duke Clinical Research Institute, National Institute on Aging (NIA), University of Michigan, The Cleveland Clinic, University of Colorado, Denver, Piedmont Healthcare, Wake Forest University Health Sciences, Morristown Medical Center
- Responsible party
- Principal investigator, Brian Lindman, Vanderbilt University Medical Center
- Investigators
- Brian R. Lindman, MD, MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077201
- Sponsor's protocol ID
- 222231
- Other IDs
- 5R01AG073633-02
- Acronym
- HOMERUNHITTER
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No