Synergizing Home Health Rehabilitation Therapy

NCT05411393 | Completed Results

• 2 other identifiers: IRB202102816 -NR21AG076972
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rehabilitation; Treatment Outcome; Health Services for the Aged; Frailty; Frail Elderly; Occupational Therapy; Activities of Daily Living; Home Health Care; Functional Status; Physical Functional Performance

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• The Motor Skills Score From the Assessment of Motor and Process Skills

  The Motor Skills score is a subscale in the Assessment of Motor and Process Skills, which evaluates the degree of motor performance when an individual performs a challenging daily activity. The score range of the subscale ranges from -3 to +4. A higher score indicates better motor performance.

  Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

Secondary Outcomes (5)

• Activity Measure Post Acute Care: Home Care Short Form

  Baseline, post-intervention (approximately 2 months from baseline), 1-month follow-up (approximately 3 months from baseline), 3-month follow-up (approximately 5 months from baseline)

• Box and Block Test

  Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

• Jebsen Hand Function Test

  Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

• Timed-Up-and-Go Test

  Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

• Short Physical Performance Battery

  Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)

Study Arms (2)

Experimental arm

EXPERIMENTAL

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; Other: Usual home health rehabilitation therapy

Control arm

OTHER

Research participants in this arm will receive usual home health care rehabilitation.

Other: Usual home health rehabilitation therapy

Interventions

ADL-enhanced program OTHER

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.

Experimental arm

Usual home health rehabilitation therapy OTHER

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.

Control arm; Experimental arm

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chiung-ju Liu
• Organization: University of Florida

c.liu1@phhp.ufl.edu

352-273-6496

Study Officials

• Chiung-ju Liu, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the group allocation of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental arm versus the control arm

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: October 6, 2022
• Primary Completion: January 10, 2025
• Study Completion: March 15, 2025
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)