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

NCT02804906 | Completed

• 1 other identifier: 16-00554
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction (AMI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Decline in self-perceived physical health (measured by SF-12 PCS)

  5 Weeks

• Mean time spent in sedentary activity

  5 Weeks

• Mortality Rate

  5 Weeks

• Hospital readmission rate

  5 Weeks

Study Arms (2)

Home-Based Physical Therapy

EXPERIMENTAL

Behavioral: Home-based physical therapy

Control-30-minute counseling session

ACTIVE COMPARATOR

Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge.

Behavioral: Usual Care

Interventions

Home-based physical therapy 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.

Home-Based Physical Therapy

Usual Care 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).

Control-30-minute counseling session

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute myocardial infarction (AMI).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• John Dodson, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: December 14, 2018
• Study Completion: January 14, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

US (1)