Activities of Daily Living, Frail Elderly, Frailty, Functional Status, Health Services for the Aged, Home Health Care, Occupational Therapy, Physical Functional Performance, Rehabilitation, Treatment Outcome
Conditions
Keywords
Rehabilitation
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.
Interventions
OTHERADL-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.
OTHERUsual 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.
Sponsors
University of Florida
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded to the group allocation of the patients.
Intervention model description
Experimental arm versus the control arm
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Motor Skills Score From the Assessment of Motor and Process Skills | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity Measure Post Acute Care: Home Care Short Form | 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) | 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. |
| Box and Block Test | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) | 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. |
| Jebsen Hand Function Test | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) | 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. |
| Timed-Up-and-Go Test | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) | 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. |
| Short Physical Performance Battery | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChiung-ju Liu, PhD
University of Florida
Participant flow
Recruitment details
Between October 6, 2022, and October 15, 2024, 47 Medicare patients were recruited from partnered home health agencies.
Pre-assignment details
There is no pre-assignment. After baseline assessment, participants were randomly assigned to the experimental group or the control group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 81.6 Years STANDARD_DEVIATION 8.2 |
| Body Mass Index | 25.5 Kilograms per square meter STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of self-reported chronic conditions | 5.4 The number of chronic conditions STANDARD_DEVIATION 2.3 |
| Pain, Enjoyment of Life, and General Activity Scale | 3.6 Score on the scale STANDARD_DEVIATION 3.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Saint Louis University Mental Status Exam | 22.4 Score STANDARD_DEVIATION 5.6 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 13 Participants |
| The number of medications currently taken | 8.2 The number of medications STANDARD_DEVIATION 4.1 |
| The Patient Health Questionnaire-9 | 6.7 Score STANDARD_DEVIATION 5.3 |
| Years of education | 14.6 Years STANDARD_DEVIATION 3.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 24 | 0 / 23 |
| other Total, other adverse events | 0 / 24 | 0 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 |
Outcome results
None listed