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NCT Number: NCT06479876

Home-Based Cardiac Rehabilitation for Patients With Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Bassim El-Sabawi, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Roll-in Phase

  • Stage C HF (NYHA Class I-III) AND
  • Discharged from a HF hospitalization OR
  • Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
  • Scheduled for appointment in a cardiology clinic with a KCCQ-SS <75
  • Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase

Randomized Controlled Trial (beyond roll-in phase)

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

Exclusion criteria

Roll-in Phase

  • Unwilling or unable to provide informed consent for participation in the RCT
  • Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
  • If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
  • History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
  • Age < 18 years
  • Stage D HF (advanced HF under evaluation for LVAD or transplant)
  • NYHA class IV symptoms
  • Congenital heart disease
  • Pregnant
  • Group 1 pulmonary hypertension
  • Moderate-severe or severe (> 3+) mitral or aortic valvular disease
  • 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 3 months
  • 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 study team physician indicates that participation in the RCT would be unsafe
  • Participation in any ongoing randomized trial that has not completed follow-up

Randomized Controlled Trial (beyond roll-in phase)

  • Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device >9 hours/day for at least 1 day.
  • Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.

Treatment and study plan

HBCR

Other

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.

Primary outcomes

  1. Average daily total activity counts

    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.

Secondary outcomes

  1. Average daily active minutes

    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.

  2. Average daily steps

    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.

  3. Average daily energy expenditure

    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.

  4. Average daily moderate to vigorous active minutes

    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.

  5. Sustained physical activity bursts of 10 minutes or greater per day

    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.

  6. 6 minute walk distance

    Time frame: The comparison will be at 12-weeks after randomization.

    The distance walked in 6 minutes.

  7. Chair sit to stand time

    Time frame: The comparison will be at 12-weeks after randomization.

    The time taken to complete 5 chair rises.

  8. 5 meter gait speed

    Time frame: The comparison will be at 12-weeks after randomization.

    The speed of walking 5 meters (meters/second).

  9. Balance test

    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).

  10. AM-PAC Basic Mobility Outpatient Short Form (Low Function)

    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)

  11. Short Physical Performance Battery Score

    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).

  12. Heart-failure specific health status assessed by the KCCQ

    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).

  13. Physical health status assessed by the PROMIS 10

    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).

  14. Mental health status assessed by the PROMIS 10

    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)

  15. Mood disturbance assessed by PHQ9

    Time frame: The comparison will be at 12-weeks after randomization.

    Patient health questionnaire 9 (PHQ9); (score range 1-27, lower is better)

  16. Behavioral Regulation In Exercise Questionnaire 3

    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).

  17. Social support and exercise survey

    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).

  18. Multidimensional Self-Efficacy for Exercise Scale

    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).

  19. General self-efficacy scale

    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).

  20. Blood pressure

    Time frame: The comparison will be at 12-weeks after randomization.

  21. Modified Heart Failure Collaborative GDMT score

    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).

  22. Probability of the hierarchical clinical event composite

    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.

  23. All-cause unplanned rehospitalization

    Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).

    This includes inpatient, observation, or ER visit.

  24. Worsening heart failure event

    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.

  25. All-cause mortality

    Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).

    Death for any reason.

  26. "Thriving patient" composite

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bassim El-Sabawi, MD

CONTACT

[email protected]

615-589-6076

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial

Acronym: MOBILE HEART

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2024
Registry last updated
Sep 24, 2025

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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