Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction (RESILIENT)
Primary Purpose
Acute Myocardial Infarction (AMI)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based physical therapy
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Myocardial Infarction (AMI)
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of acute myocardial infarction (AMI).
Exclusion Criteria:
- moderate to severe cognitive impairment; non-ambulatory
- severe heart failure (NYHA Class IV); decisional impairment as assessed by the University of California
- San Diego Brief Assessment of Capacity to Consent (UBACC) 22, if the RC questions capacity; very limited life expectancy (e.g. anticipated discharge to hospice)
- non-English/non-Spanish speaking.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home-Based Physical Therapy
Control-30-minute counseling session
Arm Description
Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge.
Outcomes
Primary Outcome Measures
Activities of Daily Living (ADL) Decline
Assessment of the functional dependence or independence in carrying out activities of daily living, including bathing, dressing, toileting, transferring, continence, and feeding.
Secondary Outcome Measures
Decline in self-perceived physical health (measured by SF-12 PCS)
Health status measure that addresses both physical and mental health.
Mean time spent in sedentary activity
Mortality Rate
Hospital readmission rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02804906
Brief Title
Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
Acronym
RESILIENT
Official Title
Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
January 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
This pilot feasibility study will test whether a home-based cardiac rehabilitation intervention, using physical therapist visits combined with mobile health technology, will prevent decline in high-risk patients post acute myocardial infarction (AMI). Participants will be randomized to either an intervention arm (home-based physical therapy), or a control (usual care) arm. Prior to discharge, participants in the intervention arm will receive a 1-hour educational session by a research physical therapist that includes information on cardiac risk factor management, postoperative recovery, education on medication adherence, and a prescription for home exercise that is tailored to each patient's baseline abilities and limitations. Participants assigned to the control arm will receive a 30-minute counseling session on risk factor modification prior to discharge, in addition to usual care post-AMI.
Detailed Description
All participants enrolled in this research study will receive the FDA-approved FitBit Flex, a wearable activity monitoring device which will objectively measure physical activity and sedentary behavior in the period post-hospital discharge. Daily activity monitoring will include: number of steps, distance traveled, calories burned, number of active minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction (AMI)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-Based Physical Therapy
Arm Type
Experimental
Arm Title
Control-30-minute counseling session
Arm Type
Active Comparator
Arm Description
Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge.
Intervention Type
Behavioral
Intervention Name(s)
Home-based physical therapy
Intervention Description
Participants will be visited by a physical therapist 3 times a week for approximately 1 hour each day, for a duration of 4 weeks. These visits will serve to encourage adherence to the intervention, reinforce activities recommended at discharge, monitor safety under direct supervision, and adjust the exercise prescription if/as needed (e.g. advance recommended activity level) if necessary. Patients will also be provided with a tablet computer device installed with software, Moving Analytics, that will reinforce the cardiac rehabilitation program through daily reminders and easily accessible visual activity plans. This program will be updated by the physical therapist during home visits as the program advances. Daily patient-reported health status ("Your Activities of Daily Living") 26 will be ascertained on the same tablet device by participants three times per week using open source software designed.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge. Participants will be provided with a tablet computer device to complete patient-reported health status ("Your Activities of Daily Living") 26 three times per week using open source software designed. Participants will be visited by the Research Coordinator or member of the study team at one month post-hospital discharge to perform a follow-up assessment that will include ADLs, IADLs, SF-12 PCS, frailty measures, and questions on healthcare utilization (hospital readmissions).
Primary Outcome Measure Information:
Title
Activities of Daily Living (ADL) Decline
Description
Assessment of the functional dependence or independence in carrying out activities of daily living, including bathing, dressing, toileting, transferring, continence, and feeding.
Time Frame
5 Weeks
Secondary Outcome Measure Information:
Title
Decline in self-perceived physical health (measured by SF-12 PCS)
Description
Health status measure that addresses both physical and mental health.
Time Frame
5 Weeks
Title
Mean time spent in sedentary activity
Time Frame
5 Weeks
Title
Mortality Rate
Time Frame
5 Weeks
Title
Hospital readmission rate
Time Frame
5 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of acute myocardial infarction (AMI).
Exclusion Criteria:
moderate to severe cognitive impairment; non-ambulatory
severe heart failure (NYHA Class IV); decisional impairment as assessed by the University of California
San Diego Brief Assessment of Capacity to Consent (UBACC) 22, if the RC questions capacity; very limited life expectancy (e.g. anticipated discharge to hospice)
non-English/non-Spanish speaking.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Dodson, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
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