Clinical trial NCT05411393: Synergizing Home Health Rehabilitation Therapy
Official title: Synergizing Home Health Rehabilitation Therapy to Optimize Patients' Activities of Daily Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-06-09
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental arm versus the control arm
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Assessment of Motor and Process Skills Assessment of Motor and Process Skills
timeFrame: Three months
measure: Activity Measure Post Acute Care: Home Care Short Form
timeFrame: six months
Secondary outcomes:
measure: Box and Block Test
timeFrame: Three months
measure: Jebsen Hand Function Test
timeFrame: Three months
measure: Timed-Up-and-Go Test
timeFrame: Three months
measure: Short Physical Performance Battery
timeFrame: Three months
Other outcomes:
measure: Self-care items from the Outcome and Assessment Information Set
timeFrame: Two months
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Chiung-ju Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: