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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG076972 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control arm | Other | Research participants in this arm will receive usual home health care rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADL-enhanced program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Patients are eligible if they
Patients are ineligible if they have
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| Name | Affiliation | Role |
|---|---|---|
| Chiung-ju Liu, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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There is no pre-assignment. After baseline assessment, participants were randomly assigned to the experimental group or the control group.
Between October 6, 2022, and October 15, 2024, 47 Medicare patients were recruited from partnered home health agencies.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2024 |
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Experimental arm versus the control arm
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The outcome assessor will be blinded to the group allocation of the patients.
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| Usual home health rehabilitation therapy | Other | 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. |
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| 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. | 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. | 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. | 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. | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) |
| FG001 | Control Arm | Research participants in this arm will receive usual home health care rehabilitation. 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm | Research participants in this arm received the ADL-enhanced program and usual home health care rehabilitation. The ADL-enhanced program consists of six home visits delivered by a study therapy interventionist. ADL-enhanced program: The ADL-enhanced program consists of six home visits delivered by a study therapy staff. The study therapy staff used the compensatory approach and the restorative approach during these visits to enhance patients' activity engagement. The compensatory approach includes 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 therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. |
| BG001 | Control Arm | Research participants in this arm received usual home health care rehabilitation. Usual home health rehabilitation therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Years of education | Mean | Standard Deviation | Years |
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| Body Mass Index | Mean | Standard Deviation | Kilograms per square meter |
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| Number of self-reported chronic conditions | Mean | Standard Deviation | The number of chronic conditions |
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| The number of medications currently taken | Mean | Standard Deviation | The number of medications |
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| Pain, Enjoyment of Life, and General Activity Scale | A pain scale with a possible score ranging from 0 to 10. A higher score indicates a higher degree of pain. | Mean | Standard Deviation | Score on the scale |
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| The Patient Health Questionnaire-9 | A depression measure with a possible score ranging from 0 to 27. A higher score indicates a higher degree of depression. | Mean | Standard Deviation | Score |
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| Saint Louis University Mental Status Exam | A global cognition measure with a possible score ranging from 0 to 30. A higher score indicates better cognitive function. | Mean | Standard Deviation | Score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | At post-intervention assessments, three participants in the treatment group did not complete the assessment. At 1-month follow-up, five participants in the treatment group and one in the control group did not complete the assessment. | Posted | Oct 2025 | Mean | Standard Deviation | Units on a scale | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) |
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| Secondary | 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. | At post-intervention assessments, three participants in the treatment group did not complete the assessment. At 1-month follow-up, five participants in the treatment group and one in the control group did not complete the assessment. At 3-month follow-up, six participants in the treatment group and two in the control group did not complete the assessment. | Posted | Mean | Standard Deviation | T Score | 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) |
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| Secondary | 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. | The data reported here are based on participants who were able to complete the test at each time point. | Posted | Mean | Standard Deviation | The number of blocks | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) |
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| Secondary | 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. | The data reported here are based on participants who were able to complete the test at each time point. | Posted | Mean | Standard Deviation | Seconds | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) |
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| Secondary | 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. | The data reported here are based on participants who were able to complete the test at each time point. | Posted | Mean | Standard Deviation | Seconds | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) |
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| Secondary | 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. | The data reported here are based on participants who were able to complete the test at each time point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline) |
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From baseline until 3-month follow-up, about 5 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Arm | Research participants in this arm received the ADL-enhanced program and usual home health care rehabilitation. The ADL-enhanced program consists of six home visits delivered by a study therapy interventionist. ADL-enhanced program: The ADL-enhanced program consists of six home visits delivered by a study therapy staff. The study therapy staff used the compensatory approach and the restorative approach during these visits to enhance patients' activity engagement. The compensatory approach includes 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 therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. | 1 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Control Arm | Research participants in this arm received usual home health care rehabilitation. Usual home health rehabilitation therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chiung-ju Liu | University of Florida | 352-273-6496 | c.liu1@phhp.ufl.edu |
| Jul 16, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2024 | Jan 24, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Post-intervention |
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| 1-month follow up |
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| OG001 | Control Arm | Research participants in this arm received usual home health care rehabilitation. Usual home health rehabilitation therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. |
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| OG001 |
| Control Arm |
Research participants in this arm received usual home health care rehabilitation. Usual home health rehabilitation therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. |
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| OG001 | Control Arm | Research participants in this arm received usual home health care rehabilitation. Usual home health rehabilitation therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. |
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| OG001 |
| Control Arm |
Research participants in this arm received usual home health care rehabilitation. Usual home health rehabilitation therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. |
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| OG001 |
| Control Arm |
Research participants in this arm received usual home health care rehabilitation. Usual home health rehabilitation therapy: Usual home health rehabilitation therapy was prescribed by the home health agency. It often included occupational therapy and physical therapy delivered in one to three home visits per week for one to two months. |
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