Clinical Trials Directory

Trials / Completed

CompletedNCT03978130

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

REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
400 (actual)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
65 Years – 110 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERmHealth-CRStudy participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device.

Timeline

Start date
2020-01-09
Primary completion
2024-04-30
Completion
2024-04-30
First posted
2019-06-06
Last updated
2025-06-06
Results posted
2025-06-06

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03978130. Inclusion in this directory is not an endorsement.