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

May 20, 2025 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Chan Medical School
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 110 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mHealth-CR
Participants in this arm will receive the mHealth-CR intervention.
Other: mHealth-CR
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.
No Intervention: Usual Care
Participants in this arm receive usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 6-minute Walking Distance (6MWD)
Time Frame: Baseline, 3 months
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
Time Frame: 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Goal Attainment, as Measured Using a 5-point Goal Attainment Scale (GAS)
Time Frame: 3 months
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).
3 months
12-Item Short Form Survey (SF-12) Score
Time Frame: Month 3
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.
Month 3
Percentage of Participants With no Residual Angina, as Measured by the Seattle Angina Questionnaire 7 (SAQ-7) (Disease-specific Health Status)
Time Frame: Baseline, 3 months
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).
Baseline, 3 months
Percentage of Participants Who Have Any ADL or IADL Impairment
Time Frame: Baseline, 3 months
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.
Baseline, 3 months
Number of Hospital Readmissions
Time Frame: 1 Year
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).
1 Year
Number of Participants Who Died From Any Cause
Time Frame: 1 Year
Data are obtainable via the electronic health record (EHR).
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Dodson, MD, New York Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-02017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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