FrailtyNCT05411393
Synergizing Home Health Rehabilitation Therapy
A study testing ADL-enhanced program and Usual home health rehabilitation therapy in people with Frailty and Frail Elderly, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Frailty, Frail Elderly, Occupational Therapy
- What is being tested?
- ADL-enhanced program and Usual home health rehabilitation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 15 Mar 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergizing Home Health Rehabilitation Therapy to Optimize Patients' Activities of Daily Living
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.
Read the 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.
- Conditions
- Frailty, Frail Elderly, Occupational Therapy, Activities of Daily Living, Home Health Care, Functional Status
- Being tested
- ADL-enhanced program, Usual home health rehabilitation therapy
- Keywords
- Rehabilitation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADL-enhanced programOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual home health rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Activity Measure Post Acute Care: Home Care Short Form is a self-reported outcome measure of functional independence to live in the community. The reported T-score is a standardized score derived from raw responses, scaled to have a mean of 50 and a standard deviation of 10 in the reference population. The Basic Mobility subscale evaluates indoor and outdoor mobility; higher scores indicate better mobility performance. The Daily Activity subscale measures the ability to perform self-care tasks at home; higher scores reflect better performance in daily activities.
Measured: 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
The test measures motor coordination of the upper extremity through moving small wooden blocks within one minute. Each hand was tested separately. A higher score indicates better hand function.
Measured: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)
Jebsen Hand Function Test
The test measures upper extremity function by recording the time it takes to complete seven daily tasks, such as writing or picking up small, common objects. A longer time to complete all tasks indicates poor hand function.
Measured: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)
Timed-Up-and-Go Test
The test measures functional mobility by recording the time it takes to get up from a chair, walk, and return to the chair. A higher score indicates poor functional mobility.
Measured: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)
Short Physical Performance Battery
The test measures balance, walking speed and chair stand. The score range is from 0 to 12. A higher score indicates better physical performance of the lower extremity.
Measured: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start6 Oct 2022
- Primary completion10 Jan 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental arm versus the control arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Chiung-ju Liu, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411393
- Sponsor's protocol ID
- IRB202102816 -N
- Other IDs
- R21AG076972
- Status last verified
- Jul 2025
- First submitted
- 6 Jun 2022
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No