Mobile Health Rehabilitation for Heart Disease

(RESILIENT Trial)

No longer recruiting at 1 trial location

Overseen By Stephanie Pena

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Non-ambulatory, Cognitive impairment, Parkinson's, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile health rehabilitation program (mHealth-CR) for people with heart disease to determine if it improves daily activity performance compared to traditional rehab. Participants will either use a mobile health tool, such as an app, or receive usual care to aid their recovery. It is best suited for individuals aged 65 or older who have recently been hospitalized for heart-related procedures and can use technology in English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for heart disease patients.

Will I have to stop taking my current medications?

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 mHealth-CR is safe for older adults with heart disease?

Research has shown that mHealth-CR, a mobile health program for heart rehabilitation, is safe for patients. Studies have found that this remote rehab is as effective and safe as traditional rehab conducted in specialized centers. Another review examined the long-term safety of remote heart rehab and found no increase in serious health risks. This indicates that the treatment is well-tolerated and does not cause more health problems compared to standard care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth-CR program for heart disease rehabilitation because it offers a unique approach by leveraging mobile health technology. Unlike traditional cardiac rehab programs that require frequent in-person visits, mHealth-CR can be accessed remotely, making it more convenient and potentially more accessible for patients. This tech-driven method allows for real-time monitoring and personalized feedback, which can enhance patient engagement and adherence. By integrating digital tools into heart disease management, mHealth-CR aims to improve outcomes while fitting seamlessly into patients' daily lives.

What evidence suggests that mHealth-CR is effective for heart disease?

Research has shown that mobile health cardiac rehabilitation (mHealth-CR), which participants in this trial may receive, can be as effective as traditional rehab at specialized centers. Some studies suggest that mobile health apps might reduce serious heart problems and hospital readmissions for heart disease patients. However, other research found that mHealth-CR did not significantly improve walking distance or other health measures compared to regular care, which is the other arm in this trial. Despite mixed results, patients often report greater satisfaction and better exercise habits with home-based rehab. Overall, mHealth-CR appears promising, but its effectiveness can vary depending on the measured outcomes. ^{1 3 4 5 6}

Who Is on the Research Team?

John Dodson, MD

Principal Investigator

New York Langone Health

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above who have been hospitalized for ischemic heart disease (like a heart attack, stent placement, or bypass surgery) recently. They must be able to walk, give consent themselves, and use mobile health technology in English or Spanish. People with severe movement disorders, very short life expectancy, severe cognitive issues, certain recent surgeries or conditions that limit walking are not eligible.

Inclusion Criteria

I can follow study instructions and perform tasks like a 6-minute walk test.

I am 65 years old or older.

I am currently in the hospital or was hospitalized in the last 2 weeks for a heart attack or heart surgery.

Exclusion Criteria

You have a left ventricular assist device.

The doctors think there are other safety concerns or you might not follow the study rules.

I have significant memory or thinking problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either mHealth-CR or usual care for cardiac rehabilitation

3 months

Weekly virtual check-ins for mHealth-CR group

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person) at 3 months

Long-term follow-up

Participants are monitored for hospital readmissions and mortality

1 year

What Are the Treatments Tested in This Trial?

Interventions

• mHealth-CR

Trial Overview The RESILIENT study tests if a mobile health cardiac rehab program (mHealth-CR) can improve the physical function of older adults after hospitalization due to heart disease better than standard care. Participants will either receive mHealth-CR or usual care in a ratio of 3:1 by random selection.

How Is the Trial Designed?

Group I: mHealth-CR Experimental Treatment 1 Intervention

Participants in this arm will receive the mHealth-CR intervention.

Group II: Usual Care Active Control 1 Intervention

Participants in this arm receive usual care.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11065672/

Effectiveness of Cardiac Rehabilitation With mHealth Through ... A Cochrane systematic review concluded that home-based mHealth CR is equally effective than rehabilitation performed in a specialized centre; however, the ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828802

Rehabilitation at Home Using Mobile Health for Older ... In this randomized clinical trial of mHealth-CR vs usual care, mHealth-CR did not significantly increase 6MWD or result in improvements in secondary outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11064579/

Effectiveness of mobile health applications on clinical ... Mobile health apps have the potential to lower the incidence of major adverse cardiac events (MACEs), readmission rates, and blood lipids in patients with CHD.

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

Effectiveness of home-based cardiac rehabilitation ... This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772374725004454

Long-Term Outcomes of Digital Cardiac Rehabilitation Several studies suggest that patients participating in home-based cardiac rehabilitation (HBCR) report higher satisfaction, better exercise adherence, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10964460/

Safety and long-term outcomes of remote cardiac ... To systematically review the safety and the long-term mortality and morbidity risk-rates of the remotely-delivered cardiac rehabilitation ...