Synergizing Home Health Rehabilitation Therapy

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05411393
• Other study ID #: IRB202102816 -N
• Secondary ID: R21AG076972
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: March 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	The Assessment of Motor and Process Skills Assessment of Motor and Process Skills	A performance-based measure of activities of daily living.	Three months
Primary	Activity Measure Post Acute Care: Home Care Short Form	A patient-report outcome measure in mobility and self-care activities.	six months
Secondary	Box and Block Test	The test measures motor coordination of the upper extremity through moving small wooden blocks.	Three months
Secondary	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
Secondary	Timed-Up-and-Go Test	The test measures functional mobility from getting up from a chair, walking, and returning to the chair.	Three months
Secondary	Short Physical Performance Battery	The test measures balance, walking speed and chair stand.	Three months