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

NCT ID: NCT02804906

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-01-14

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.

Conditions

Acute Myocardial Infarction (AMI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Home-Based Physical Therapy

Group Type: EXPERIMENTAL

Home-based physical therapy

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Dodson, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-00554

Identifier Type: -

Identifier Source: org_study_id