N/A
N=400
Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease
Ischemic Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT03978130 ↗Enrolled (actual)
400
Serious AEs
5.8%
Results posted
Jun 2025
Primary outcome: Primary: Change in 6-minute Walking Distance (6MWD) — 41.2; 25.6 meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mHealth-CR (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 6-minute Walking Distance (6MWD) |
41.2; 25.6 | — |
| PRIMARY Number of Participants in Each Engagement Phenotype on Intervention Arm |
81; 93; 124 | — |
| SECONDARY Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS) |
25.7; 20.9 | — |
| SECONDARY 12-Item Short Form Survey (SF-12) Score |
46.3; 48.2 | — |
| SECONDARY Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status) |
25.7; 20.9 | — |
| SECONDARY Percentage of Participants Who Have Any ADL or IADL Impairment |
9.7; 10.6 | — |
| SECONDARY Number of Hospital Readmissions |
56; 16 | — |
| SECONDARY Number of Participants Who Died From Any Cause |
5; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥65
- Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks.
- Capable of self-consent.
- Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).
Exclusion Criteria
- Non-ambulatory.
- Moderate or severe cognitive impairment.
- Unable/unwilling to consent.
- PCI-related groin hematoma that precludes brisk walking.
- Incarcerated.
- Unable to use mHealth software in English or Spanish.
- Severe osteoarthritis, or joint replacement within last 3 months.
- Parkinson's disease or other progressive movement disorder.
- Regular use of walker for ambulation.
- Projected life expectancy <3 months.
- Clinical judgment concerning other safety or nonadherence issues.
- Participants admitted from long-term care facility.
- Currently listed for heart transplant.
- Left ventricular assist device recipient.
- Completion of ambulatory cardiac rehabilitation program within prior 3 months.
Data sourced from ClinicalTrials.gov (NCT03978130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.