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

NCT03978130 | Completed Results

• 1 other identifier: 18-02017
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (2)

• Change in 6-minute Walking Distance (6MWD)

  Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6-minute walk test (6MWT) is a submaximal exercise test in which the pace is self-selected by the participant. The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse. The outcome change in 6MWD is calculated as 3 month 6MWD minus baseline 6MWD.

  Baseline, 3 months

• Number of Participants in Each Engagement Phenotype on Intervention Arm

  Weekly engagement will be measured as the fraction of the following 11 elements completed each week: (1-7) daily entry of exercise data and relative perceived exertion (RPE); (8) completed weekly phone call with exercise therapist; (9) at least one electronic communication with exercise therapist; (10) watching educational video (which will vary by week); and (11) at least one home BP measurement. Engagement will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all 11 activities completed). The participants in the intervention arm will be grouped into 3 engagement phenotypes based on their scores: 1) Persistently Low, 2) Intermediate Declining, and 3) Persistently High.

  3 months

Secondary Outcomes (6)

• Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS)

  3 months

• 12-Item Short Form Survey (SF-12) Score

  Month 3

• Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status)

  Baseline, 3 months

• Percentage of Participants Who Have Any ADL or IADL Impairment

  Baseline, 3 months

• Number of Hospital Readmissions

  1 Year

Study Arms (2)

mHealth-CR

EXPERIMENTAL

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

Other: mHealth-CR

Usual Care

NO INTERVENTION

Participants in this arm receive usual care.

Interventions

mHealth-CR OTHER

Study 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.

mHealth-CR

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (3)

• Barua S, Upadhyay D, Pena S, McConnell R, Varghese A, Adhikari S, LeRoy E, Schoenthaler A, Dodson JA. Adherence to Accelerometer Use in Older Adults Undergoing mHealth Cardiac Rehabilitation: Secondary Analysis of a Randomized Clinical Trial. J Med Internet Res. 2025 Dec 23;27:e80522. doi: 10.2196/80522.

  PMID: 41435373 DERIVED

• Dodson JA, Adhikari S, Schoenthaler A, Hochman JS, Sweeney G, George B, Marzo K, Jennings LA, Kovell LC, Vorsanger M, Pena S, Meng Y, Varghese A, Johanek C, Rojas M, McConnell R, Whiteson J, Troxel AB. Rehabilitation at Home Using Mobile Health for Older Adults Hospitalized for Ischemic Heart Disease: The RESILIENT Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2453499. doi: 10.1001/jamanetworkopen.2024.53499.

  PMID: 39775808 DERIVED

• 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.

  PMID: 35238793 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: John Dodson, MD
• Organization: NYU Langone Health

john.dodson@nyulangone.org

6465012714

Study Officials

• John Dodson, MD

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: partial mask (outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: January 9, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Requests should be directed to john.dodson@nyumc.org. To gain access, data requestors will need to sign a data access agreement. The investigator who proposed to use the data.

Locations

US (2)