Trial Outcomes & Findings for Community Participation Transition After Stroke (NCT NCT02396589)
NCT ID: NCT02396589
Last Updated: 2025-08-27
Results Overview
We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests.
COMPLETED
NA
15 participants
12 months
2025-08-27
Participant Flow
Participant milestones
| Measure |
Education Group
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Intervention
STARTED
|
6
|
9
|
|
Intervention
COMPLETED
|
5
|
9
|
|
Intervention
NOT COMPLETED
|
1
|
0
|
|
6 Month Follow-up
STARTED
|
5
|
9
|
|
6 Month Follow-up
COMPLETED
|
5
|
8
|
|
6 Month Follow-up
NOT COMPLETED
|
0
|
1
|
|
9 Month Follow-up
STARTED
|
5
|
8
|
|
9 Month Follow-up
COMPLETED
|
5
|
7
|
|
9 Month Follow-up
NOT COMPLETED
|
0
|
1
|
|
12 Month Follow up
STARTED
|
5
|
7
|
|
12 Month Follow up
COMPLETED
|
5
|
5
|
|
12 Month Follow up
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Education Group
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Intervention
Lost to Follow-up
|
1
|
0
|
|
6 Month Follow-up
change in health status
|
0
|
1
|
|
9 Month Follow-up
Death
|
0
|
1
|
|
12 Month Follow up
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Community Participation Transition After Stroke
Baseline characteristics by cohort
| Measure |
Education Group
n=6 Participants
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
n=9 Participants
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 8.21 • n=93 Participants
|
66.9 years
STANDARD_DEVIATION 7.96 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 7.85 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
9 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Length of Stay in Inpatient Rehabilitation
|
16.7 days
STANDARD_DEVIATION 53.5 • n=93 Participants
|
24.1 days
STANDARD_DEVIATION 7.9 • n=4 Participants
|
21.1 days
STANDARD_DEVIATION 7.8 • n=27 Participants
|
|
Stroke Impact Scale (SIS) Total
|
40.83 units on a scale
STANDARD_DEVIATION 22.00 • n=93 Participants
|
38.33 units on a scale
STANDARD_DEVIATION 21.79 • n=4 Participants
|
39.33 units on a scale
STANDARD_DEVIATION 21.12 • n=27 Participants
|
|
Reintegration to Normal Living Index (RNLI)
|
62.88 units on a scale
STANDARD_DEVIATION 22.24 • n=93 Participants
|
52.73 units on a scale
STANDARD_DEVIATION 18.87 • n=4 Participants
|
56.79 units on a scale
STANDARD_DEVIATION 20.12 • n=27 Participants
|
|
SIS Activity of Daily Living (ADL) Subscale
|
52.83 units on a scale
STANDARD_DEVIATION 15.03 • n=93 Participants
|
37.11 units on a scale
STANDARD_DEVIATION 17.09 • n=4 Participants
|
43.4 units on a scale
STANDARD_DEVIATION 17.64 • n=27 Participants
|
|
In-Home Occupational Performance Measure (I-HOPE) Performance
|
16.00 units on a scale
STANDARD_DEVIATION 7.72 • n=93 Participants
|
21.22 units on a scale
STANDARD_DEVIATION 5.76 • n=4 Participants
|
19.13 units on a scale
STANDARD_DEVIATION 6.88 • n=27 Participants
|
|
I-HOPE Satisfaction
|
16.67 units on a scale
STANDARD_DEVIATION 9.40 • n=93 Participants
|
19.33 units on a scale
STANDARD_DEVIATION 5.94 • n=4 Participants
|
18.27 units on a scale
STANDARD_DEVIATION 7.31 • n=27 Participants
|
|
I-HOPE Environmental Barriers
|
58.67 barrier score
STANDARD_DEVIATION 35.01 • n=93 Participants
|
85.44 barrier score
STANDARD_DEVIATION 22.47 • n=4 Participants
|
74.73 barrier score
STANDARD_DEVIATION 30.18 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 15 participants were randomized (treatment group n=9 and education group n=6). 12 participants were included in this analysis. One participant in the education group was not able to finish education visits and was excluded from the analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
We will explore the safety of the intervention by determining the rate and severity of falls (calculated with an algorithm). Scores are as follows: 0, those with no falls, 1, those with one fall without serious injury, 2, those with at least two falls without serious injury, and 3, those with one or more falls causing serious injury. Maximum score of three indicates an increased severity of fall. We will compare the difference in scores between groups using t-tests.
Outcome measures
| Measure |
Education Group
n=5 Participants
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
n=7 Participants
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Rate and Severity of Falls (Calculated With an Algorithm)
|
2 score on a scale
Standard Deviation .316
|
2 score on a scale
Standard Deviation .00
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: A total of 14 participants were analyzed. One participant in the education group was not able to finish the education visits and was excluded from this analysis.
The does of the intervention as measured in minutes received by both groups. The number of minutes reported is the average of the total for each participant in each group.
Outcome measures
| Measure |
Education Group
n=5 Participants
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
n=9 Participants
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Intervention Dose (Minutes)
|
354.8 number of treatment minutes
Standard Deviation 120.1
|
365 number of treatment minutes
Standard Deviation 108.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 15 participants were randomized (treatment group n=9 and education group n=6). 12 participants were included in this analysis. One participant in the education group was not able to finish education visits and was excluded from the analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
We analyzed health care utilization by examining the number of emergency department visits, outpatient physical and occupational therapy visits, and doctor visits. The total number of each was calculated for each participant and the average is reported here.
Outcome measures
| Measure |
Education Group
n=5 Participants
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
n=7 Participants
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Health Care Utilization, Number of Emergency Department Visits
Outpatient doctor visits
|
10.33 Number of visits
Standard Deviation 10.86
|
26.11 Number of visits
Standard Deviation 30.10
|
|
Health Care Utilization, Number of Emergency Department Visits
Emergency Room Visits
|
.50 Number of visits
Standard Deviation .55
|
.56 Number of visits
Standard Deviation .88
|
|
Health Care Utilization, Number of Emergency Department Visits
Outpatient physical therapy visits
|
28.67 Number of visits
Standard Deviation 34.72
|
26.11 Number of visits
Standard Deviation 30.10
|
|
Health Care Utilization, Number of Emergency Department Visits
Outpatient occupational therapy visits
|
36.00 Number of visits
Standard Deviation 36.30
|
19.44 Number of visits
Standard Deviation 24.14
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: A total of 14 participants were analyzed. One participant in the education group was not able to finish the education visits and was excluded from this analysis.
The does of the intervention as measured by amount of treatment minutes received by both groups. The total number of treatment sessions was calculated for each participant and the average is reported here.
Outcome measures
| Measure |
Education Group
n=5 Participants
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
n=9 Participants
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Intervention Dose, Number of Treatment Sessions
|
4.4 number of treatment sessions
Standard Deviation 1.3
|
5 number of treatment sessions
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 15 participants were randomized (treatment group n=9 and education group n=6). 12 participants were included in this analysis. One participant in the education group was not able to finish education visits and was excluded from the analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
We analyzed health care utilization by examining the number of days participants in each group spent in the hospital. The total number of days was calculated for participants in each group and the average is reported here.
Outcome measures
| Measure |
Education Group
n=5 Participants
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
n=7 Participants
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Health Care Utilization, Days of Hospitalization
|
0 days
Standard Deviation 0
|
.67 days
Standard Deviation 1.12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 monthsPopulation: 9 participants were randomized to the treatment group. 7 participants were included in this analysis. Two participants in the treatment group were lost to follow up (drop out due to change in health n=1, drop out due to death n=1), and were excluded from analysis.
Adherence to the intervention will be measured by examine the number of recommendations implemented per recommendations suggested. Long-term adherence will be calculated as the number of recommendations used at 9 months per recommendations suggested.
Outcome measures
| Measure |
Education Group
n=7 Participants
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
Intervention Adherence
|
71.25 percentage of recommendations used
Standard Deviation 31
|
—
|
Adverse Events
Education Group
Home Modifications Group
Serious adverse events
| Measure |
Education Group
n=6 participants at risk
Participants in the Education group receive five 90 minute tailored stroke education sessions in the home.
Education Group: Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
|
Home Modifications Group
n=9 participants at risk
Participants in the treatment group receive a home assessment and home modifications tailored to functional abilities (pre discharge) and then five 90 minute occupational therapy treatment sessions at home (post discharge) to improve functional abilities and community participation.
Home Modifications Group: The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
|---|---|---|
|
General disorders
Hospitalization
|
0.00%
0/6
|
0.00%
0/9
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Susan Stark
Washington University in St. Louis School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place