Mobile Health Program for Heart Failure

(RURAL-HF Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Reduced ejection fraction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

332 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile health program can help people with heart failure improve their health from home. The study compares two groups: one using a home-based cardiac rehabilitation app and another with activity tracking but no exercise plan. It targets individuals who have experienced heart failure hospitalizations and have a heart function level (ejection fraction) of 35% or higher. Participants must be able to use a smartphone and participate in telemedicine visits. The goal is to determine if this home-based program can reduce deaths, decrease hospital visits, and improve quality of life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile health program is safe for heart failure patients?

Earlier studies have shown that home-based cardiac rehabilitation is safe for people with heart failure. Research indicates that this type of program can reduce hospital visits and improve quality of life. Most patients with stable heart conditions manage it well.

One detailed review examined results for people with heart failure and found that home-based programs are generally safe, with no major safety issues reported. This suggests that the mobile health (mHealth) version of this program could also be well-received.

While specific data from this trial is not yet available, existing research supports the safety of home-based cardiac rehab for heart failure patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Program for Heart Failure because it offers a fresh approach to cardiac rehabilitation by leveraging technology. Unlike traditional cardiac rehab, which typically requires in-person visits to a clinic or hospital, this program uses the Movn app to deliver rehabilitation at home. This mobile health (mHealth) approach makes it easier for patients to incorporate exercise and health monitoring into their daily lives, potentially increasing adherence and improving outcomes. Additionally, the attention control group utilizes a wearable device for tracking steps, which helps ensure that all participants stay engaged with their health without a formal exercise plan. This trial could pave the way for more accessible, patient-friendly cardiac care.

What evidence suggests that this mobile health program is effective for heart failure?

Research shows that home-based cardiac rehabilitation can be effective for people with heart failure. Studies comparing center-based rehab with home-based rehab have found similar improvements in heart health and quality of life. In this trial, participants in one arm will receive cardiac rehabilitation through the Movn app, a mobile health program designed to help patients manage their condition from home. Some research suggests that home-based programs can be more affordable than traditional facility-based rehab. Overall, evidence supports that this mobile health approach could be a helpful option for heart failure patients. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who've been hospitalized before, have an ejection fraction of at least 35%, can use a smartphone, and are willing to do cardiac rehab at home. It's not suitable for those unable to attend telemedicine visits or participate in the program.

Inclusion Criteria

I can do doctor visits online.

I have a smartphone or device for the health app.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week mHealth cardiac rehabilitation program or attention control intervention

12 weeks

Remote monitoring and bi-weekly telephone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Continuous monitoring through mHealth platform

What Are the Treatments Tested in This Trial?

Interventions

• Home-based Cardiac Rehabilitation

Trial Overview The study tests a mobile health (mHealth) cardiac rehab program using the Movn app and an accelerometer against standard care. Participants will be split into two groups randomly, focusing on rural vs urban populations, to see how well it works over six months.

How Is the Trial Designed?

Group I: Movn cardiac rehabilitation Experimental Treatment 1 Intervention

Cardiac rehabilitation delivered through Movn app through the use of mHealth.

Group II: Attention Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. movnhealth.com movnhealth.com/science

Movn Health | Science ... Rehab for Heart Failure ... Cost Analysis of Remote Cardiac Rehabilitation Compared With Facility-Based Cardiac Rehabilitation for Coronary Artery Disease.

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.119.012779

Home‐Based Cardiac Rehabilitation Alone and Hybrid ... Center‐based cardiac rehabilitation (CBCR) has been shown to improve outcomes in patients with heart failure (HF). Home‐based cardiac ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213177924008576

Center- vs Home-Based Cardiac Rehabilitation in Patients ... Original Research. Heart Failure. Center- vs Home-Based Cardiac Rehabilitation in Patients With Heart Failure: EXIT-HF Randomized Controlled Trial.

4. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(25)00012-3/fulltext

Effectiveness of home-based cardiac rehabilitation ... We found several clinical trials evaluating the effects of phase II mHealth HBCR in patients with coronary heart disease and heart failure.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8445013/

The role of cardiac rehabilitation in improving cardiovascular ... For example, both meta-regression analyses reported in the Cochrane reviews on coronary heart disease and heart failure indicate that the ...

6. movnhealth.com movnhealth.com/blog-posts/safety-in-cardiac-rehab-a-primer

Safety in Cardiac Rehab – A Primer ... safe, including in patients with stable heart failure (HF). An ... Otherwise, most patients with stable cardiovascular disease should ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481471/

Home‐based versus centre‐based cardiac rehabilitation - PMC Over time, CHD can weaken the heart muscle and lead to arrhythmias or heart failure. Coronary heart disease causes significant morbidity and mortality, and as a ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06349941

Home-based Cardiac Rehabilitation in Heart Failure This study evaluates a mobile health (mHealth) home-based cardiac rehabilitation program for patients with heart failure. We will stratify randomization ...

9. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000663

Home-Based Cardiac Rehabilitation: A Scientific Statement ... CR programs reduce morbidity and mortality rates in adults with ischemic heart disease, heart failure, or cardiac surgery but are significantly ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0147956322000978

Safety of home-based cardiac rehabilitation: A systematic ... ... outcomes in cardiovascular disease ... Dean, et al. Home-based cardiac rehabilitation for people with heart failure: a systematic review and meta-analysis.