Ischemic Heart DiseaseRESILIENTNCT03978130
Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease
A study testing mHealth-CR in people with Ischemic Heart Disease, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- mHealth-CR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jan 2020to 30 Apr 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Health
New York, New York, 10016
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
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.
Read the 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
- Ischemic Heart Disease
- Being tested
- mHealth-CR
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth-CROther
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth-CR | Experimental | Participants in this arm will receive the mHealth-CR intervention. Receives: Other: mHealth-CR |
| Usual Care | No intervention | Participants in this arm receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (6)
Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS)
Using the SMART goal framework, GAS describes the person's expected level of goal achievement over 3 months, ranging from no change (scored as -2) to much better than expected (scored as +2) out of a 5 point-scale. Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. Overall score is calculated by incorporating the goal of outcomes scores into an aggregated t-score. Goal attainment, through goal setting, is an especially important outcome in older adults who may begin an intervention with a variety of deficits (therefore necessitating individualized therapy towards realistic goals).
Measured: 3 months
12-Item Short Form Survey (SF-12) Score
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. For the SF-12, the 3 month score will be analyzed using a threshold of 5 points in SF-12 physical component score (PCS) as a clinically meaningful change.
Measured: Month 3
Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status)
The Seattle Angina Questionnaire-7 (SAQ-7) is a self-administered questionnaire that measures patient-reported health measures related to coronary artery disease (CAD). The SAQ-7 is scored from 0 to 100, with higher scores indicating better health status, less frequent angina, and better quality of life (0-24: Poor health status; 25-49: Fair; 50-74: Good; 75-100: Excellent). For SAQ-7, we will analyze at a single time point (3 months) the number of participants who have residual angina (SAQ-7<100) vs. no angina (SAQ-7=100).
Measured: Baseline, 3 months
Percentage of Participants Who Have Any ADL or IADL Impairment
Defined as any improvement or worsening in basic (BADLs) or instrumental (IADLs) over 3 months. The Bristol Activities of Daily Living Scale (BADL) measures basic self-care behaviors: feeding, toileting, bathing, dressing, and ambulating. The score is interpreted based on the total score, which ranges from 0 to 60. Higher scores indicate greater independence in daily living activities. The Lawton Instrumental Activities of Daily Living (IADL) scale measures activities that allow a person to live independently (e.g. food preparation, medication management, transportation, shopping, managing finances, using the telephone, and housekeeping). The total score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: Baseline, 3 months
Number of Hospital Readmissions
Defined as number of participants who were readmitted into the hospital with an overnight stay (including observation) in any hospital within 12 months of hospitalization. Data are obtainable via the electronic health record (EHR).
Measured: 1 Year
Number of Participants Who Died From Any Cause
Data are obtainable via the electronic health record (EHR).
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start9 Jan 2020
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- John Dodson, MD, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978130
- Sponsor's protocol ID
- 18-02017
- Acronym
- RESILIENT
- Status last verified
- May 2025
- First submitted
- 5 Jun 2019
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 41435373Shwayder EM, Dodson JA, Adhikari S, Grant EV, Schoenthaler AM, Pena S, Meng Y, Jennings LA. Goal Attainment Among Older Adults With Ischemic Heart Disease Using Mobile-Health Cardiac Rehabilitation in RESILIENT. JACC Adv. 2025 Dec;4(12 Pt 1):102298. doi: 10.1016/j.jacadv.2025.102298. Epub 2025 Nov 12.
PubMed 41231194Dodson 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.
PubMed 39775808Dodson 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.
PubMed 35238793