RECRUITING

Home-Based Cardiac Rehabilitation for Patients With Heart Failure

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-05

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06479876

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 1. Willingness to continue and participate in the study visits and other study activities required for the RCT	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 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.

Inclusion Criteria

Exclusion Criteria

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

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
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.

Contacts and Locations

Study Contact

Bassim El-Sabawi, MD

CONTACT

615-589-6076

bassim.el-sabawi@vumc.org

Principal Investigator

Brian R Lindman, MD, MSCI

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Brian R Lindman, MD, MSCI, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-05

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-08-05

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

cardiac rehabilitation, physical activity, functional capacity, quality of life, outcomes

Additional Relevant MeSH Terms

Heart Failure With Preserved Ejection Fraction
Heart Failure With Reduced Ejection Fraction
Cardiovascular Diseases