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

Valvular Heart Disease Clinical Trial

— HOMERUNHITTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077201
• Other study ID #: 222231
• Secondary ID: 5R01AG073633-02
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: June 2024
• Source: Vanderbilt University Medical Center
• Contact: Anna Vatterott, MPH
• Phone: 615-936-5798
• Email: anna.vatterott[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: October 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Other:
• HBCR 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.
• HBCR interactive
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (12)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Duke Clinical Research Institute, Inova Fairfax Hospital, Medical University of South Carolina, Morristown Medical Center, National Institute on Aging (NIA), Piedmont Healthcare, The Cleveland Clinic, University of Colorado, Denver, University of Michigan, University of Pittsburgh, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Primary	Average daily total activity counts	Daily total activity counts are determined by a triaxial actigraphy device.	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	Average daily total activity counts	Daily total activity counts are determined by a triaxial actigraphy device.	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.
Secondary	Average daily active minutes	Daily active minutes are determined by a triaxial actigraphy device.	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.
Secondary	Average daily steps	Daily steps are determined by a triaxial actigraphy device.	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.
Secondary	Average daily energy expenditure	Daily energy expenditure is determined by a triaxial actigraphy device.	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.
Secondary	Average daily moderate to vigorous active minutes	Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.	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.
Secondary	6 minute walk distance	The distance walked in 6 minutes.	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	Chair sit to stand time	The time taken to complete 5 chair rises.	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	5 meter gait speed	The speed of walking 5 meters (meters/second).	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	All-cause hospitalizations	Hospitalizations for any reason	Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Secondary	All-cause death	Death for any cause	Over the entire available follow-up period for randomized participants (minimum of 6 months, maximum approximately 24-30 months).
Secondary	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)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	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)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	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)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	Mood disturbance assessed by PHQ9	Patient health questionnaire 9 (PHQ9); (score range 1-27, higher score worse)	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	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.	The comparisons will be at 12, 24 and 52 weeks after randomization.
Secondary	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)	The comparisons will be at 12, 24 and 52 weeks after randomization.