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

• ClinicalTrials.gov Identifier: NCT03978130
• Recruitment Status: Active, not recruiting
• First Posted: June 6, 2019
• Last Update Posted: March 6, 2024
• Sponsor: NYU Langone Health
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: June 5, 2019
• First Posted Date: June 6, 2019
• Last Update Posted Date: March 6, 2024
• Actual Study Start Date: January 9, 2020
• Actual Primary Completion Date: January 10, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 18, 2019)

Change in 6-minute walking distance (6MWD) [ Time Frame: 3 month ]

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.

Original Primary Outcome Measures (submitted: June 5, 2019)

Change in the 6MWD between Baseline and 3 Month Follow Up [ Time Frame: 3 Months ]

Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse.

Current Secondary Outcome Measures (submitted: October 18, 2019)

• Goal Attainment measured using a 5-point goal attainment scale (GAS) [ Time Frame: 3 month ]
  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).
• Participant reported health status - measured using the SF-12 [ Time Frame: 3 month ]
  Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). For the SF-12, we will analyze change from baseline to 3 months using a threshold of 5 points in SF-12 physical component score (PCS) as a clinically meaningful change
• Participant reported health status - measured Seattle Angina Questionnaire 7 (SAQ-7) (disease-specific health status). [ Time Frame: 3 month ]
  Health status encompasses a person's functional status, symptoms, and wellbeing, and is increasingly recognized as an important patient-centered outcome. Both the SF-12 and SAQ-7 have been validated and are convenient for participants (<5 minutes to administer). 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).
• Change in Basic Activities of Daily Living (BADLs) [ Time Frame: 3 month ]
  defined as any improvement or worsening in basic (BADLs) over 3 months. BADLs are basic self-care behaviors: feeding, toileting, bathing, dressing, and ambulating. I
• Change in Activities of Daily Living (ADLs) [ Time Frame: 3 months. ]
  defined as any improvement or worsening in instrumental (IADLs) activities of daily living over 3 months. ADLs are activities that allow a person to live independently (e.g. food preparation, medication management, transportation, shopping, managing finances, using the telephone, and housekeeping).
• Hospital readmissions evaluated at 3, 6 and 12 Months [ 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 3, 6, and 12 months of hospitalization. Data are obtainable via the electronic health record (EHR).
• Death [ Time Frame: 1 Year ]
  is defined by number of participants who died from any cause within 3, 6, and 12 months of enrollment. Data are obtainable via the electronic health record (EHR).

Original Secondary Outcome Measures (submitted: June 5, 2019)

Goal Attainment as measured by goal attainment scaling (GAS) [ Time Frame: 3 Months ]

defined as whether a person's individual functional goals are achieved as a result of the study intervention, measured using a 5-point goal attainment scale

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

partial mask (outcomes assessor)

Primary Purpose: Treatment

• Condition: Ischemic Heart Disease

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.

Study Arms

• Experimental: mHealth-CR
  Intervention: Other: mHealth-CR
• No Intervention: Usual Care

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 25, 2019): 400
• Original Estimated Enrollment (submitted: June 5, 2019): 300
• Estimated Study Completion Date: April 30, 2024
• Actual Primary Completion Date: January 10, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years to 110 Years (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03978130
• Other Study ID Numbers: 18-02017
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (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.

• Current Responsible Party: NYU Langone Health
• Original Responsible Party: Same as current
• Current Study Sponsor: NYU Langone Health
• Original Study Sponsor: Same as current
• Collaborators: National Institutes of Health (NIH)

Investigators

• Principal Investigator: John Dodson, MD; New York Langone Health

• PRS Account: NYU Langone Health
• Verification Date: March 2024