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

Primary Purpose

Ischemic Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth-CR
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

65 Years - 110 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mHealth-CR

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Goal Attainment 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).
Participant reported health status - measured using the SF-12
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).
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)
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)
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
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
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).

Full Information

First Posted
June 5, 2019
Last Updated
April 24, 2023
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03978130
Brief Title
Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease
Acronym
RESILIENT
Official Title
REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
partial mask (outcomes assessor)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mHealth-CR
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
mHealth-CR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 6-minute walking distance (6MWD)
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Goal Attainment measured using a 5-point goal attainment scale (GAS)
Description
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).
Time Frame
3 month
Title
Participant reported health status - measured using the SF-12
Description
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
Time Frame
3 month
Title
Participant reported health status - measured Seattle Angina Questionnaire 7 (SAQ-7) (disease-specific health status).
Description
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).
Time Frame
3 month
Title
Change in Basic Activities of Daily Living (BADLs)
Description
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
Time Frame
3 month
Title
Change in Activities of Daily Living (ADLs)
Description
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).
Time Frame
3 months.
Title
Hospital readmissions evaluated at 3, 6 and 12 Months
Description
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).
Time Frame
1 Year
Title
Death
Description
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).
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Pena
Phone
(646) 618-2841
Email
RESILIENT@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Dodson, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Fonceva
Phone
646-939-5791
Email
RESILIENT@nyulangone.org
First Name & Middle Initial & Last Name & Degree
John Dodson, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35238793
Citation
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.
Results Reference
derived

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

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