Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease (RESILIENT)

NYU Langone Health

Status: Completed

Conditions: Ischemic Heart Disease

Treatments: Other: mHealth-CR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03978130

18-02017

Details and patient eligibility

About

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.

Full description

The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age ≥65) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.

Enrollment: 400 patients

Sex: All

Ages: 65 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥65
2. Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks.
3. Capable of self-consent.
4. Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).

Exclusion criteria

1. Non-ambulatory.
2. Moderate or severe cognitive impairment.
3. Unable/unwilling to consent.
4. PCI-related groin hematoma that precludes brisk walking.
5. Incarcerated.
6. Unable to use mHealth software in English or Spanish.
7. Severe osteoarthritis, or joint replacement within last 3 months.
8. Parkinson's disease or other progressive movement disorder.
9. Regular use of walker for ambulation.
10. Projected life expectancy <3 months.
11. Clinical judgment concerning other safety or nonadherence issues.
12. Participants admitted from long-term care facility.
13. Currently listed for heart transplant.
14. Left ventricular assist device recipient.
15. Completion of ambulatory cardiac rehabilitation program within prior 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

mHealth-CR

Experimental group

Description:

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

Treatment:

Other: mHealth-CR

Usual Care

No Intervention group

Description:

Participants in this arm receive usual care.