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NCT06479876Active, not recruiting

Home-Based Cardiac Rehabilitation for Patients With Heart Failure

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

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
24 Jun 2024
Start date
5 Aug 2024
Primary completion date
Jan 2027
Lead sponsor
Vanderbilt University Medical Center
NCT number
NCT06479876

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 5 Aug 2024 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Stage D HF (advanced HF under evaluation for LVAD or transplant)
  • Planned surgery within 3 months

Other illness

  • 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.
  • Congenital heart disease
  • 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)

Age

  • Age \< 18 years

Other

  • 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.
  • NYHA class IV symptoms
  • Pregnant
  • 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.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vanderbilt University Medical Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.