Synergizing Home Health Rehabilitation Therapy

Synergizing Home Health Rehabilitation Therapy to Optimize Patients' Activities of Daily Living

The objective of this project is to pilot test an ADL (activities of daily living)-enhanced program as an adjuvant therapy to usual home health rehabilitation to improve patient outcomes. The project will compare the ADL-enhanced program plus usual care with usual care using an RCT design in home health patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Frailty; Rehabilitation; Frail Elderly; Activities of Daily Living; Functional Status; Occupational Therapy; Physical Functional Performance; Treatment Outcome; Health Services for the Aged; Home Health Care
• Intervention / Treatment: Other: ADL-enhanced program; Other: Usual home health rehabilitation therapy

Detailed Description

Regaining the ability to take care of oneself after an illness or medical episode is critical for home health patients to maintain independent living at home. An ADL-enhanced program may augment the effect of home health rehabilitation therapy to support patients' self-care outcomes. Patients will be randomly assigned to two groups: one will receive the ADL-enhanced program with usual home health care, and the other will receive usual home health care. Researchers will compare outcomes in self-care activities and physical performance between the two groups to determine the effect of the ADL-enhanced program.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiung-ju Liu, PhD; Phone Number: 352-273-6496; Email: c.liu1@phhp.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Patients are eligible if they

• are 65 years of age over older
• are Medicare beneficiaries
• are referred for skilled rehabilitation services at the partnered home health agency
• have three or more comorbidities

Patients are ineligible if they have

• acute fractures with surgical or weight-bearing restrictions,
• elective joint replacement surgery
• lower-extremity amputation
• active treatment for cancer diagnosis
• ongoing dialysis treatment
• acute cardiac surgery,
• acute stroke or a major neurologic disorder limiting motor movements
• terminal stage of congestive heart failure
• a referral to hospice care
• severe cognitive deficits limiting verbal communication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; Research participants in this arm will receive the ADL-enhanced program and usual home health care rehabilitation. The ADL-enhanced program consists of six home visits delivered by a study occupational therapist.	Other: ADL-enhanced program; The ADL-enhanced program consists of six home visits delivered by a study occupational therapy staff. The study therapy staff will use the compensatory approach and the restorative approach during the visits to enhance patients' activity engagement. The compensatory approach uses strategies to reduce the activity demand to make every task easier. For example, using the sitting position to perform self-care tasks. The restorative approach uses strategies to increase the demand of the task to increase the patient's functional capacity. For example, carrying a full-load laundry basket versus an empty laundry basket.; Other: Usual home health rehabilitation therapy; Usual home health rehabilitation therapy is prescribed by the home health agency. It often includes occupational therapy and physical therapy delivered in one to three home visits per week for one to two months.
Other: Control arm; Research participants in this arm will receive usual home health care rehabilitation.	Other: Usual home health rehabilitation therapy; Usual home health rehabilitation therapy is prescribed by the home health agency. It often includes occupational therapy and physical therapy delivered in one to three home visits per week for one to two months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Assessment of Motor and Process Skills Assessment of Motor and Process Skills	A performance-based measure of activities of daily living.	Three months
Activity Measure Post Acute Care: Home Care Short Form	A patient-report outcome measure in mobility and self-care activities.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block Test	The test measures motor coordination of the upper extremity through moving small wooden blocks.	Three months
Jebsen Hand Function Test	The test measures upper extremity function in seven tasks: sentence writing, card turning, moving small common objects (e.g., pennies), simulated feeding, stacking checkers, moving light objects, and moving heavy objects.	Three months
Timed-Up-and-Go Test	The test measures functional mobility from getting up from a chair, walking, and returning to the chair.	Three months
Short Physical Performance Battery	The test measures balance, walking speed and chair stand.	Three months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-care items from the Outcome and Assessment Information Set	The self-care items evaluate the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, shower/bathe, and putting on/removing footwear.	Two months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Chiung-ju Liu, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: IRB202102816 -N; R21AG076972 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No