Home-Based Cardiac Rehabilitation for Patients With Heart Failure

Description

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.

Conditions

Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Cardiovascular Diseases

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Study Overview

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Study Details

Study overview

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.

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

Home-Based Cardiac Rehabilitation for Patients With Heart Failure

Condition
Heart Failure With Preserved Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Brian R Lindman, MD, MSCI, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2025-10