Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Location contact
Bassim El-Sabawi, MD
CONTACT
NCT Number: NCT06479876
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Bassim El-Sabawi, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Roll-in Phase
Randomized Controlled Trial (beyond roll-in phase)
Exclusion criteria
Roll-in Phase
Randomized Controlled Trial (beyond roll-in phase)
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.
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.
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 activity minutes determined. The comparison will be at 12 weeks after randomization.
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 steps determined. The comparison will be at 12 weeks after randomization.
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 energy expenditure determined. The comparison will be at 12-weeks after randomization.
Average 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 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.
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 comparison will be at 12 weeks after randomization.
Physical activity bursts are determined by a triaxial actigraphy device.
Time frame: The comparison will be at 12-weeks after randomization.
The distance walked in 6 minutes.
Time frame: The comparison will be at 12-weeks after randomization.
The time taken to complete 5 chair rises.
Time frame: The comparison will be at 12-weeks after randomization.
The speed of walking 5 meters (meters/second).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: The comparison will be at 12-weeks after randomization.
Patient health questionnaire 9 (PHQ9); (score range 1-27, lower is better)
Time frame: 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).
Time frame: The comparison will be at 12-weeks after randomization.
Social support and exercise survey (score range per question of 1-5, higher is better).
Time frame: 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).
Time frame: The comparison will be at 12-weeks after randomization.
General self-efficacy scale (GSE); (score range per question of 1-4, higher is better).
Time frame: The comparison will be at 12-weeks after randomization.
Time frame: 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).
Time frame: 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.
Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
This includes inpatient, observation, or ER visit.
Time frame: 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.
Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
Death for any reason.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Vanderbilt University Medical Center
Other
Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial
Acronym: MOBILE HEART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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