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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ischemic Heart Disease	Other: mHealth-CR	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: partial mask (outcomes assessor)
• Primary Purpose: Treatment
• Official Title: REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
• Actual Study Start Date: January 9, 2020
• Actual Primary Completion Date: January 10, 2024
• Estimated Study Completion Date: April 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: mHealth-CR	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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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
3. 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).
4. 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
5. 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).
6. 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).
7. 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).

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 110 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

UMass Chan Medical School

Worcester, Massachusetts, United States, 01655

United States, New York

NYU Langone Health

New York, New York, United States, 10016

Sponsors and Collaborators

NYU Langone Health

National Institutes of Health (NIH)

Investigators

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

  Study Documents (Full-Text)

Documents provided by NYU Langone Health:

Informed Consent Form  [PDF] February 14, 2023

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03978130
• Other Study ID Numbers: 18-02017
• First Posted: June 6, 2019
• Last Update Posted: March 6, 2024
• Last Verified: March 2024

Individual Participant Data (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; 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.

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

Additional relevant MeSH terms:

Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases