Trial Outcomes & Findings for Synergizing Home Health Rehabilitation Therapy (NCT NCT05411393)
NCT ID: NCT05411393
Last Updated: 2026-01-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)
Results posted on
2026-01-22
Participant Flow
Between October 6, 2022, and October 15, 2024, 47 Medicare patients were recruited from partnered home health agencies.
There is no pre-assignment. After baseline assessment, participants were randomly assigned to the experimental group or the control group.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
18
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Illness or loss of interest
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Synergizing Home Health Rehabilitation Therapy
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=24 Participants
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.
|
Control Arm
n=23 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81.6 Years
STANDARD_DEVIATION 8.2 • n=270 Participants
|
83.1 Years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
82.3 Years
STANDARD_DEVIATION 7.5 • n=9 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=270 Participants
|
19 Participants
n=4 Participants
|
34 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=270 Participants
|
19 Participants
n=4 Participants
|
35 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=270 Participants
|
22 Participants
n=4 Participants
|
46 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Years of education
|
14.6 Years
STANDARD_DEVIATION 3.4 • n=270 Participants
|
15.2 Years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
14.9 Years
STANDARD_DEVIATION 3.1 • n=9 Participants
|
|
Body Mass Index
|
26.7 Kilograms per square meter
STANDARD_DEVIATION 5.8 • n=270 Participants
|
25.5 Kilograms per square meter
STANDARD_DEVIATION 5.6 • n=4 Participants
|
26.1 Kilograms per square meter
STANDARD_DEVIATION 5.7 • n=9 Participants
|
|
Number of self-reported chronic conditions
|
5.3 The number of chronic conditions
STANDARD_DEVIATION 2.2 • n=270 Participants
|
5.6 The number of chronic conditions
STANDARD_DEVIATION 2.5 • n=4 Participants
|
5.4 The number of chronic conditions
STANDARD_DEVIATION 2.3 • n=9 Participants
|
|
The number of medications currently taken
|
8 The number of medications
STANDARD_DEVIATION 3.9 • n=270 Participants
|
8.3 The number of medications
STANDARD_DEVIATION 4.5 • n=4 Participants
|
8.2 The number of medications
STANDARD_DEVIATION 4.1 • n=9 Participants
|
|
Pain, Enjoyment of Life, and General Activity Scale
|
4 Score on the scale
STANDARD_DEVIATION 3.1 • n=270 Participants
|
3.6 Score on the scale
STANDARD_DEVIATION 3.2 • n=4 Participants
|
3.8 Score on the scale
STANDARD_DEVIATION 3.1 • n=9 Participants
|
|
The Patient Health Questionnaire-9
|
6.4 Score
STANDARD_DEVIATION 5.2 • n=270 Participants
|
7.1 Score
STANDARD_DEVIATION 5.5 • n=4 Participants
|
6.7 Score
STANDARD_DEVIATION 5.3 • n=9 Participants
|
|
Saint Louis University Mental Status Exam
|
21.9 Score
STANDARD_DEVIATION 6.1 • n=270 Participants
|
22.9 Score
STANDARD_DEVIATION 5 • n=4 Participants
|
22.4 Score
STANDARD_DEVIATION 5.6 • n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)Population: 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.
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.
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
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.
|
Control Arm
n=23 Participants
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.
|
|---|---|---|
|
The Motor Skills Score From the Assessment of Motor and Process Skills
Baseline
|
1.3 Units on a scale
Standard Deviation 0.4
|
1.1 Units on a scale
Standard Deviation 0.5
|
|
The Motor Skills Score From the Assessment of Motor and Process Skills
Post-intervention
|
1.3 Units on a scale
Standard Deviation 0.5
|
1.4 Units on a scale
Standard Deviation 0.5
|
|
The Motor Skills Score From the Assessment of Motor and Process Skills
1-month follow up
|
1.5 Units on a scale
Standard Deviation 0.5
|
1.5 Units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
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.
|
Control Arm
n=23 Participants
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.
|
|---|---|---|
|
Activity Measure Post Acute Care: Home Care Short Form
Basic mobility subscale at baseline
|
51.2 T Score
Standard Deviation 7.0
|
49.5 T Score
Standard Deviation 6.6
|
|
Activity Measure Post Acute Care: Home Care Short Form
Daily activity subscale at baseline
|
48.7 T Score
Standard Deviation 8.0
|
47.5 T Score
Standard Deviation 8.9
|
|
Activity Measure Post Acute Care: Home Care Short Form
Basic mobility subscale at post-intervention
|
51.8 T Score
Standard Deviation 5.7
|
52.2 T Score
Standard Deviation 8.0
|
|
Activity Measure Post Acute Care: Home Care Short Form
Basic mobility subscale at 1-month follow-up
|
52.0 T Score
Standard Deviation 4.3
|
52.5 T Score
Standard Deviation 9.0
|
|
Activity Measure Post Acute Care: Home Care Short Form
Basic mobility subscale at 3-month follow-up
|
54.2 T Score
Standard Deviation 6.4
|
54.8 T Score
Standard Deviation 8.2
|
|
Activity Measure Post Acute Care: Home Care Short Form
Daily activity subscale at post-intervention
|
51.1 T Score
Standard Deviation 7.7
|
50.6 T Score
Standard Deviation 8.7
|
|
Activity Measure Post Acute Care: Home Care Short Form
Daily activity subscale at 1-month follow-up
|
51.2 T Score
Standard Deviation 8.5
|
51.1 T Score
Standard Deviation 8.7
|
|
Activity Measure Post Acute Care: Home Care Short Form
Daily activity subscale at 3-month follow-up
|
49.1 T Score
Standard Deviation 8.6
|
52.7 T Score
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)Population: The data reported here are based on participants who were able to complete the test at each time point.
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.
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
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.
|
Control Arm
n=23 Participants
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.
|
|---|---|---|
|
Box and Block Test
Right hand at baseline
|
40.1 The number of blocks
Standard Deviation 7.2
|
38.6 The number of blocks
Standard Deviation 9.5
|
|
Box and Block Test
Right hand at post-intervention
|
41.9 The number of blocks
Standard Deviation 8.7
|
39.5 The number of blocks
Standard Deviation 7.4
|
|
Box and Block Test
Right hand at 1-month follow-up
|
41.3 The number of blocks
Standard Deviation 7.9
|
39.15 The number of blocks
Standard Deviation 9.2
|
|
Box and Block Test
Left hand at baseline
|
39.6 The number of blocks
Standard Deviation 7.0
|
36.3 The number of blocks
Standard Deviation 9.1
|
|
Box and Block Test
Left-hand at post-intervention
|
39 The number of blocks
Standard Deviation 8.9
|
36.8 The number of blocks
Standard Deviation 9.1
|
|
Box and Block Test
Left-hand at 1-month follow-up
|
36.8 The number of blocks
Standard Deviation 11.6
|
38.3 The number of blocks
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)Population: The data reported here are based on participants who were able to complete the test at each time point.
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.
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
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.
|
Control Arm
n=23 Participants
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.
|
|---|---|---|
|
Jebsen Hand Function Test
1-month follow-up
|
88.9 Seconds
Standard Deviation 72.6
|
78.0 Seconds
Standard Deviation 22.8
|
|
Jebsen Hand Function Test
Post-intervention
|
86.9 Seconds
Standard Deviation 60.0
|
83.0 Seconds
Standard Deviation 28.6
|
|
Jebsen Hand Function Test
Baseline
|
82.7 Seconds
Standard Deviation 49.7
|
84.0 Seconds
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)Population: The data reported here are based on participants who were able to complete the test at each time point.
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.
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
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.
|
Control Arm
n=23 Participants
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.
|
|---|---|---|
|
Timed-Up-and-Go Test
1-month follow-up
|
24.2 Seconds
Standard Deviation 10.9
|
23.5 Seconds
Standard Deviation 14.4
|
|
Timed-Up-and-Go Test
Baseline
|
24.5 Seconds
Standard Deviation 13.2
|
30.6 Seconds
Standard Deviation 18.7
|
|
Timed-Up-and-Go Test
Post-intervention
|
22.8 Seconds
Standard Deviation 9.3
|
24.7 Seconds
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline)Population: The data reported here are based on participants who were able to complete the test at each time point.
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.
Outcome measures
| Measure |
Experimental Arm
n=24 Participants
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.
|
Control Arm
n=23 Participants
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.
|
|---|---|---|
|
Short Physical Performance Battery
Baseline
|
3.7 Score on a scale
Standard Deviation 2.2
|
4.0 Score on a scale
Standard Deviation 2.5
|
|
Short Physical Performance Battery
Post-intervention
|
4.1 Score on a scale
Standard Deviation 1.7
|
4.6 Score on a scale
Standard Deviation 2.6
|
|
Short Physical Performance Battery
1-month follow up
|
4.3 Score on a scale
Standard Deviation 1.9
|
4.9 Score on a scale
Standard Deviation 2.8
|
Adverse Events
Experimental Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place