Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction (RESILIENT)

• ClinicalTrials.gov Identifier: NCT02804906
• Recruitment Status: Completed
• First Posted: June 17, 2016
• Last Update Posted: January 22, 2020
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: June 14, 2016
• First Posted Date: June 17, 2016
• Last Update Posted Date: January 22, 2020
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: December 14, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2016)

Activities of Daily Living (ADL) Decline [ Time Frame: 5 Weeks ]

Assessment of the functional dependence or independence in carrying out activities of daily living, including bathing, dressing, toileting, transferring, continence, and feeding.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 14, 2016)

• Decline in self-perceived physical health (measured by SF-12 PCS) [ Time Frame: 5 Weeks ]
  Health status measure that addresses both physical and mental health.
• Mean time spent in sedentary activity [ Time Frame: 5 Weeks ]
• Mortality Rate [ Time Frame: 5 Weeks ]
• Hospital readmission rate [ Time Frame: 5 Weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
• Official Title: Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Acute Myocardial Infarction (AMI)

Intervention

• Behavioral: Home-based physical therapy
  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.
• Behavioral: Usual Care
  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).

Study Arms

• Experimental: Home-Based Physical Therapy
  Intervention: Behavioral: Home-based physical therapy
• Active Comparator: Control-30-minute counseling session
  Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge.
  Intervention: Behavioral: Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 21, 2020): 27
• Original Estimated Enrollment (submitted: June 14, 2016): 40
• Actual Study Completion Date: January 14, 2019
• Actual Primary Completion Date: December 14, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 70 Years and older (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: NCT02804906
• Other Study ID Numbers: 16-00554
• 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: Not Provided
• Responsible Party: NYU Langone Health
• Study Sponsor: NYU Langone Health
• Collaborators: Not Provided

Investigators

• Principal Investigator: John Dodson, MD; New York University Medical School

• PRS Account: NYU Langone Health
• Verification Date: January 2020