Implementing a Home-based Cardiac Rehabilitation Program Among Rural Patients With Heart Failure

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study evaluates a mobile health (mHealth) home-based cardiac rehabilitation program for patients with heart failure. We will stratify randomization between rural and urban populations, with the goal to assess implementation of cardiac rehabilitation across these two geographic areas. . The study will randomize 332 patients with heart failure (ejection fraction ≥35%) who are not eligible for center-based rehabilitation to either a 12-week mHealth cardiac rehabilitation program or an attention control group, with outcomes measured over 6 months using a composite endpoint of mortality, hospitalizations, and quality of life. We will then assess the implementation of the intervention.

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

• Adults aged 18 years or older

• History of hospitalization for acute heart failure with ejection fraction ≥ 35%

• Ability to participate in telemedicine visits

• Access to smartphone or device capable of running the mHealth application

• Willingness to participate in home-based cardiac rehabilitation program

Locations
United States
Texas
Baylor Scott and White Health System
NOT_YET_RECRUITING
Dallas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 332
Treatments
Experimental: Movn cardiac rehabilitation
Cardiac rehabilitation delivered through Movn app through the use of mHealth.
Active_comparator: Attention Control
This group will receive a wearable device for step count tracking and will get periodic check ins to minimize differential attention between groups. They will not receive an exercise plan.
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov