Home-Based Cardiac Rehabilitation for Patients With Heart Failure
- Conditions
- Heart Failure With Reduced Ejection FractionCardiovascular DiseasesHeart Failure With Preserved Ejection Fraction
- Registration Number
- NCT06479876
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Average daily total activity counts 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. Daily total activity counts are determined by a triaxial actigraphy device.
- Secondary Outcome Measures
Name Time Method Average daily active minutes 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. Daily active minutes are determined by a triaxial actigraphy device.
Average daily steps 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. Daily steps are determined by a triaxial actigraphy device.
Average daily energy expenditure 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. Average daily energy expenditure is determined by a triaxial actigraphy device.
Average daily moderate to vigorous active minutes 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. Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.
Sustained physical activity bursts of 10 minutes or greater per day 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. Physical activity bursts are determined by a triaxial actigraphy device.
6 minute walk distance The comparison will be at 12-weeks after randomization. The distance walked in 6 minutes.
Chair sit to stand time The comparison will be at 12-weeks after randomization. The time taken to complete 5 chair rises.
5 meter gait speed The comparison will be at 12-weeks after randomization. The speed of walking 5 meters (meters/second).
Balance test The comparison will be at 12-weeks after randomization. Score based on ability to stand unsupported for 10 seconds with feet in a certain position (feet together, semi tandem, full tandem). Score ranges from 0-4 (higher score is better).
AM-PAC Basic Mobility Outpatient Short Form (Low Function) The comparison will be at 12-weeks after randomization. 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, higher score is better)
Short Physical Performance Battery Score The comparison will be at 12-weeks after randomization. Composite score including 3 components (Chair sit to stand, 5 meter gait speed, balance test). Score ranges from 0-12 (higher score is better).
Heart-failure specific health status assessed by the KCCQ The comparison will be at 12-weeks after randomization. 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 The comparison will be at 12-weeks after randomization. Global physical health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20, higher is better).
Mental health status assessed by the PROMIS 10 The comparison will be at 12-weeks after randomization. Global mental health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20, higher is better)
Mood disturbance assessed by PHQ9 The comparison will be at 12-weeks after randomization. Patient health questionnaire 9 (PHQ9); (score range 1-27, lower is better)
Blood pressure The comparison will be at 12-weeks after randomization. Behavioral Regulation In Exercise Questionnaire 3 The comparison will be at 12-weeks after randomization. Behavioral Regulation In Exercise Questionnaire 3 (BREQ-3); (score range per question of 0-4, higher is better).
Social support and exercise survey The comparison will be at 12-weeks after randomization. Social support and exercise survey (score range per question of 1-5, higher is better).
Multidimensional Self-Efficacy for Exercise Scale The comparison will be at 12-weeks after randomization. Multidimensional Self-Efficacy for Exercise Scale (MSES); (score range per question of 0-10, higher is better).
General self-efficacy scale The comparison will be at 12-weeks after randomization. General self-efficacy scale (GSE); (score range per question of 1-4, higher is better).
Modified Heart Failure Collaborative GDMT score The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less. Guideline directed medical therapy (GDMT) score includes 4 components of RAASi, BB, SGLT2i, and MRA (maximum score of 9, higher scores indicate increased GDMT utilization).
Probability of the hierarchical clinical event composite Over the entire available follow-up period for randomized participants (minimum of 12 weeks). The hierarchical clinical event composite includes (in order of hierarchy): (1) all-cause death and (2) all-cause hospitalization. To examine whether the intervention improves mortality and hospitalization, in heart failure patients, we will conduct Bayesian Markov longitudinal proportional odds model on weekly outcome measures. The 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 active treatment group to the control group.
All-cause unplanned rehospitalization Over the entire available follow-up period for randomized participants (minimum of 12 weeks). This includes inpatient, observation, or ER visit.
Worsening heart failure event Over the entire available follow-up period for randomized participants (minimum of 12 weeks). This includes inpatient, observation, ER visit, or urgent clinic visit for worsening heart failure.
All-cause mortality Over the entire available follow-up period for randomized participants (minimum of 12 weeks). Death for any reason.
"Thriving patient" composite The comparison will be made at 12 weeks. Percent of patients that meet the following criteria: 1) alive 2) no all-cause hospitalization 3) Improvement in average daily total activity counts by 10% or greater from baseline to 12 weeks.
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center🇺🇸Nashville, Tennessee, United StatesBassim El-Sabawi, MDContact