Home-Based Cardiac Rehabilitation for Patients With Heart Failure (MOBILE HEART)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Heart Failure With Preserved Ejection Fraction; Cardiovascular Diseases; Heart Failure With Reduced Ejection Fraction

Treatments: Other: HBCR

Study type: Interventional

Funder types: Other

Identifiers

NCT06479876

240749

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Roll-in Phase

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

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

Exclusion criteria

Roll-in Phase

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

Randomized Controlled Trial (beyond roll-in phase)

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Home-based cardiac rehabilitation mobile health intervention

Experimental group

Description:

Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.

Treatment:

Other: HBCR

Control

No Intervention group

Description:

Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living.