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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Stage C HF (NYHA Class I-III) AND

‣ Discharged from a HF hospitalization OR

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

⁃ Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75

• 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

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Bassim El-Sabawi, MD
bassim.el-sabawi@vumc.org
615-589-6076
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Treatments
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.
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.
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov