Clinical trial NCT06479876: Home-Based Cardiac Rehabilitation for Patients With Heart Failure
Official title: Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases
Keywords: cardiac rehabilitation, physical activity, functional capacity, quality of life, outcomes
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized 1:1 to 2 groups.
Primary purpose: TREATMENT

Brief summary: The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.


Eligibility criteria: Inclusion Criteria:

Roll-in Phase

1. Stage C HF (NYHA Class I-III) AND

   1. Discharged from a HF hospitalization (all LVEFs) OR
   2. Scheduled for appointment in HF clinic with a prior HF hospitalization within the past 12 months with LVEF \>35%
2. Receives longitudinal HF care at VUMC main campus, including at least one visit prior to the roll-in phase

Randomized Controlled Trial (beyond roll-in phase)

1. Willingness to continue and participate in the study visits and other study activities required for the RCT

Exclusion Criteria:

Roll-in Phase

1. Unwilling or unable to provide informed consent for participation in the RCT
2. 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)
3. Age \< 18 years
4. Stage D HF (advanced HF under evaluation for LVAD or transplant)
5. NYHA class IV symptoms
6. Congenital heart disease
7. Pregnant
8. Group 1 pulmonary hypertension
9. Moderate-severe or severe (3+ or greater) valvular heart disease
10. 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)
11. Planned surgery within 3 months
12. Pacemaker or internal cardioverter defibrillator placement or revision performed within past 1 month or planned within 3 months
13. Prior Cardiomems placement or planned in next 3 months
14. 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)
15. Treating provider or study team physician indicates that participation in the RCT would be unsafe
16. Participation in any ongoing randomized trial that has not completed follow-up

Randomized Controlled Trial (beyond roll-in phase)

1. Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 7) compliant days (worn at least 10 hours/day).
2. Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.

Primary 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 primary comparison will be at 12 weeks after randomization.
Secondary outcomes:
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 activity minutes determined. The comparison will be at 12 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 comparison will be at 12 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 comparison will be at 12-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 comparison will be at 12-weeks after randomization.
measure: Sustained physical activity bursts of 10 minutes or greater per day
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 comparison will be at 12 weeks after randomization.
measure: 6 minute walk distance
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Chair sit to stand time
timeFrame: The comparison will be at 12-weeks after randomization.
measure: 5 meter gait speed
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Balance test
timeFrame: The comparison will be at 12-weeks after randomization.
measure: AM-PAC Basic Mobility Outpatient Short Form (Low Function)
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Short Physical Performance Battery Score
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Heart-failure specific health status assessed by the KCCQ
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Physical health status assessed by the PROMIS 10
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Mental health status assessed by the PROMIS 10
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Mood disturbance assessed by PHQ9
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Behavioral Regulation In Exercise Questionnaire 3
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Social support and exercise survey
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Multidimensional Self-Efficacy for Exercise Scale
timeFrame: The comparison will be at 12-weeks after randomization.
measure: General self-efficacy scale
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Patient goals progress score
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Blood pressure
timeFrame: The comparison will be at 12-weeks after randomization.
measure: Modified Heart Failure Collaborative GDMT score
timeFrame: The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less.
measure: Probability of the hierarchical clinical event composite
timeFrame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
measure: All-cause rehospitalization
timeFrame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
measure: Worsening heart failure event
timeFrame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
measure: All-cause mortality
timeFrame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
measure: "Thriving patient" composite
timeFrame: The comparison will be made at 12 weeks.
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, MSCI
role: PRINCIPAL_INVESTIGATOR
References: