Home-Based Cardiac Rehabilitation for Patients With Heart Failure

NCT ID: NCT06479876

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2026-08-31

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home-based cardiac rehabilitation mobile health intervention

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

Group Type: EXPERIMENTAL

HBCR

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HBCR

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Stage C HF (NYHA Class I-III) AND

1. Discharged from a HF hospitalization OR

2. Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR

3. Scheduled for appointment in a cardiology clinic with a KCCQ-SS <75

2. 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

Exclusion Criteria

1. Unwilling or unable to provide informed consent for participation in the RCT

2. 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

3. 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.

4. 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.

5. Age < 18 years

6. Stage D HF (advanced HF under evaluation for LVAD or transplant)

7. NYHA class IV symptoms

8. Congenital heart disease

9. Pregnant

10. Group 1 pulmonary hypertension

11. Moderate-severe or severe (> 3+) mitral or aortic valvular disease

12. 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)

13. Planned surgery within 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 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.

2. Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brian Lindman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian R Lindman, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bassim El-Sabawi, MD

Role: CONTACT

bassim.el-sabawi@vumc.org

615-589-6076

Facility Contacts

Bassim El-Sabawi, MD

Role: primary

Other Identifiers

240749

Identifier Type: -

Identifier Source: org_study_id