Clinical trial NCT03978130: Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease
Official title: REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-06-06
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in 6-minute Walking Distance (6MWD)
timeFrame: Baseline, 3 months
measure: Number of Participants in Each Engagement Phenotype on Intervention Arm
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS)
timeFrame: 3 months
measure: 12-Item Short Form Survey (SF-12) Score
timeFrame: Month 3
measure: Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status)
timeFrame: Baseline, 3 months
measure: Percentage of Participants Who Have Any ADL or IADL Impairment
timeFrame: Baseline, 3 months
measure: Number of Hospital Readmissions
timeFrame: 1 Year
measure: Number of Participants Who Died From Any Cause
timeFrame: 1 Year
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: John Dodson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dodson JA, Schoenthaler A, Sweeney G, Fonceva A, Pierre A, Whiteson J, George B, Marzo K, Drewes W, Rerisi E, Mathew R, Aljayyousi H, Chaudhry SI, Hajduk AM, Gill TM, Estrin D, Kovell L, Jennings LA, Adhikari S. Rehabilitation Using Mobile Health for Older Adults With Ischemic Heart Disease in the Home Setting (RESILIENT): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 3;11(3):e32163. doi: 10.2196/32163.