Synergizing Home Health Rehabilitation Therapy

Sponsor
University of Florida (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05411393
Collaborator
National Institute on Aging (NIA) (NIH)
48
2
19.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ADL-enhanced program
  • Other: Usual home health rehabilitation therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Experimental arm versus the control armExperimental arm versus the control arm
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcome assessor will be blinded to the group allocation of the patients.
Primary Purpose:
Treatment
Official Title:
Synergizing Home Health Rehabilitation Therapy to Optimize Patients' Activities of Daily Living
Anticipated Study Start Date :
Sep 15, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The Assessment of Motor and Process Skills Assessment of Motor and Process Skills [Three months]

    A performance-based measure of activities of daily living.

  2. Activity Measure Post Acute Care: Home Care Short Form [six months]

    A patient-report outcome measure in mobility and self-care activities.

Secondary Outcome Measures

  1. Box and Block Test [Three months]

    The test measures motor coordination of the upper extremity through moving small wooden blocks.

  2. Jebsen Hand Function Test [Three months]

    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.

  3. Timed-Up-and-Go Test [Three months]

    The test measures functional mobility from getting up from a chair, walking, and returning to the chair.

  4. Short Physical Performance Battery [Three months]

    The test measures balance, walking speed and chair stand.

Other Outcome Measures

  1. Self-care items from the Outcome and Assessment Information Set [Two months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Florida
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Chiung-ju Liu, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT05411393
Other Study ID Numbers:
  • IRB202102816
  • R21AG076972
First Posted:
Jun 9, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022