Home-based cardiac rehabilitation for heart failure patients

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

This study is testing a home-based program using a special app to help people with heart failure improve their health and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06479876 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial evaluates a home-based cardiac rehabilitation (HBCR) intervention for patients with heart failure, utilizing a custom app and digital tools. Participants are randomized into either a control group or the HBCR intervention group after a brief roll-in period. The intervention focuses on improving key health behaviors and includes traditional cardiac rehabilitation components. The study aims to assess the impact of HBCR on physical activity, quality of life, clinical events, and other relevant outcomes.

Who should consider this trial

Good fit: Ideal candidates are individuals with heart failure (NYHA Class I-III) who have been recently hospitalized or are scheduled for follow-up care.

Not a fit: Patients with advanced heart failure (Stage D) or those unable to walk independently may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life and functional capacity for patients with heart failure.

How similar studies have performed: Other studies have shown promise in home-based rehabilitation approaches, suggesting potential for success in this novel intervention.

Eligibility criteria

Inclusion Criteria Roll-in Phase

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 Roll-in Phase

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.

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Brian R Lindman, MD, MSCI — Vanderbilt University Medical Center
• Study coordinator: Bassim El-Sabawi, MD

Conditions Heart Failure With Preserved Ejection Fraction; Heart Failure With Reduced Ejection Fraction; Cardiovascular Diseases; cardiac rehabilitation, physical activity, functional capacity, quality of life, outcomes