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

Acute Myocardial Infarction (AMI) Clinical Trial

— RESILIENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804906
• Other study ID #: 16-00554
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 14, 2019

Study information

• Verified date: January 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 14, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction (AMI)
• Infarction
• Myocardial Infarction

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.
• 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).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 Weeks
Secondary	Decline in self-perceived physical health (measured by SF-12 PCS)	Health status measure that addresses both physical and mental health.	5 Weeks
Secondary	Mean time spent in sedentary activity		5 Weeks
Secondary	Mortality Rate		5 Weeks
Secondary	Hospital readmission rate		5 Weeks