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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804906
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction (AMI) Behavioral: Home-based physical therapy Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Rehabilitation in the Home Setting for Older Adults In the Early Period After Myocardial Infarction
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : January 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home-Based Physical Therapy 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.

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.
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Mean time spent in sedentary activity [ Time Frame: 5 Weeks ]
  3. Mortality Rate [ Time Frame: 5 Weeks ]
  4. Hospital readmission rate [ Time Frame: 5 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804906


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: John Dodson, MD New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02804906    
Other Study ID Numbers: 16-00554
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases