Recruiting
Phase 3

mHealth Rehabilitation

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06349941

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Movn app

Accelerometer

Study Details

Brief 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.

Conditions

Heart Failure

Study ID

NCT06349941

Start date

Aug 15, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged 18 years or older
  • History of hospitalization for acute heart failure within the last 12 months
  • 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

Exclusion Criteria:

  • Inability to participate in physical exercise or cardiac rehabilitation due to medical contraindications
  • Inability to provide informed consent
  • Lack of access to required technology (smartphone, internet connectivity)
  • Life expectancy less than 6 months
  • Inability to participate in telemedicine visits or remote monitoring
  • Current participation in another cardiac rehabilitation program

Study Design

Enrollment

332 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Movn app

Participants will have 12-week home-based exercise program delivered via a commercially available home-based cardiac rehabilitation platform called Movn. The plan includes an accelerometer, blood pressure scale, and mobile application.

Accelerometer

Participants will receive a FitBit for monitoring of physical function.

Primary outcome measure

  • Composite Hierarchical Endpoint [ Time Frame: 6 months. ]

Central Contacts and Locations

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75209

Contacts

Ambarish Pandey, MD

214-645-9868ambarish.pandey@utsouthwestern.edu

Baylor Scott and White Health System

Recruiting

Dallas, Texas, United States, 75246

Contacts

Neil Keshvani, MD

214-645-7181neil.keshvani@bswhealth.org

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • telehealth
  • heart failure
  • rural
  • cardiac rehabilitaion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-02.