Synergizing Home Health Rehabilitation Therapy
Primary Purpose
Frailty, Frail Elderly, Occupational Therapy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADL-enhanced program
Usual home health rehabilitation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Frailty focused on measuring Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental arm
Control arm
Arm Description
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.
Research participants in this arm will receive usual home health care rehabilitation.
Outcomes
Primary Outcome Measures
The Assessment of Motor and Process Skills Assessment of Motor and Process Skills
A performance-based measure of activities of daily living.
Activity Measure Post Acute Care: Home Care Short Form
A patient-report outcome measure in mobility and self-care activities.
Secondary Outcome Measures
Box and Block Test
The test measures motor coordination of the upper extremity through moving small wooden blocks.
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.
Timed-Up-and-Go Test
The test measures functional mobility from getting up from a chair, walking, and returning to the chair.
Short Physical Performance Battery
The test measures balance, walking speed and chair stand.
Full Information
NCT ID
NCT05411393
First Posted
June 6, 2022
Last Updated
May 3, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05411393
Brief Title
Synergizing Home Health Rehabilitation Therapy
Official Title
Synergizing Home Health Rehabilitation Therapy to Optimize Patients' Activities of Daily Living
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Frail Elderly, Occupational Therapy, Activities of Daily Living, Home Health Care, Functional Status, Physical Functional Performance, Rehabilitation, Treatment Outcome, Health Services for the Aged
Keywords
Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental arm versus the control arm
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to the group allocation of the patients.
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
Research participants in this arm will receive usual home health care rehabilitation.
Intervention Type
Other
Intervention Name(s)
ADL-enhanced program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual home health rehabilitation therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Assessment of Motor and Process Skills Assessment of Motor and Process Skills
Description
A performance-based measure of activities of daily living.
Time Frame
Three months
Title
Activity Measure Post Acute Care: Home Care Short Form
Description
A patient-report outcome measure in mobility and self-care activities.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Box and Block Test
Description
The test measures motor coordination of the upper extremity through moving small wooden blocks.
Time Frame
Three months
Title
Jebsen Hand Function Test
Description
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.
Time Frame
Three months
Title
Timed-Up-and-Go Test
Description
The test measures functional mobility from getting up from a chair, walking, and returning to the chair.
Time Frame
Three months
Title
Short Physical Performance Battery
Description
The test measures balance, walking speed and chair stand.
Time Frame
Three months
Other Pre-specified Outcome Measures:
Title
Self-care items from the Outcome and Assessment Information Set
Description
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.
Time Frame
Two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiung-ju Liu, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Synergizing Home Health Rehabilitation Therapy
We'll reach out to this number within 24 hrs