Home-Based Cardiac Rehabilitation for Patients With Heart Failure

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants randomized 1:1 to 2 groups.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Assessments performed at baseline visit and final (12-week visit) will be performed by a study team member unaware of randomization group. Clinical outcomes upon completion study will be assessed by an adjudicator who is blinded to randomization group.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Other: 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.
No Intervention
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.

Recruiting Locations

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Bassim El-Sabawi, MD

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Bassim El-Sabawi, MD
615-589-6076
bassim.el-sabawi@vumc.org