Mobile Health Rehabilitation for Heart Disease

(RESILIENT Trial)

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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.

Research Team

John Dodson, MD

Principal Investigator

New York Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+