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

NCT02804906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-01-22

No results posted yet for this study

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)

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • John Dodson, MD · New York University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-12-14
Completion
2019-01-14

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804906 on ClinicalTrials.gov