Trial Outcomes & Findings for A Novel Transition Program to Reduce Disability After Stroke (NCT NCT03485820)
NCT ID: NCT03485820
Last Updated: 2025-08-27
Results Overview
The RNLI is a disability-related quality-of life-instrument used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185 participants
Primary outcome timeframe
Baseline and 12 months post-stroke
Results posted on
2025-08-27
Participant Flow
Participant milestones
| Measure |
COMPASS
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
100
|
|
Overall Study
COMPLETED
|
77
|
66
|
|
Overall Study
NOT COMPLETED
|
8
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed is lower than overall number of baseline participants due to missing data.
Baseline characteristics by cohort
| Measure |
COMPASS
n=85 Participants
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
n=100 Participants
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.0 • n=85 Participants
|
66.3 years
STANDARD_DEVIATION 9.0 • n=100 Participants
|
66.3 years
STANDARD_DEVIATION 9.0 • n=185 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=85 Participants
|
45 Participants
n=100 Participants
|
80 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=85 Participants
|
55 Participants
n=100 Participants
|
105 Participants
n=185 Participants
|
|
Race/Ethnicity, Customized
Black
|
45 Participants
n=85 Participants
|
63 Participants
n=100 Participants
|
108 Participants
n=185 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=85 Participants
|
36 Participants
n=100 Participants
|
76 Participants
n=185 Participants
|
|
Race/Ethnicity, Customized
Not listed
|
0 Participants
n=85 Participants
|
1 Participants
n=100 Participants
|
1 Participants
n=185 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=85 Participants
|
100 participants
n=100 Participants
|
185 participants
n=185 Participants
|
|
Marital status
Married/partner
|
48 Participants
n=85 Participants
|
44 Participants
n=100 Participants
|
92 Participants
n=185 Participants
|
|
Marital status
Single/divorced/widowed
|
37 Participants
n=85 Participants
|
56 Participants
n=100 Participants
|
93 Participants
n=185 Participants
|
|
Living situation
Lives alone
|
26 Participants
n=85 Participants
|
32 Participants
n=100 Participants
|
58 Participants
n=185 Participants
|
|
Living situation
Lives with someone
|
59 Participants
n=85 Participants
|
68 Participants
n=100 Participants
|
127 Participants
n=185 Participants
|
|
Type of stroke
Ischemic
|
70 Participants
n=85 Participants
|
78 Participants
n=100 Participants
|
148 Participants
n=185 Participants
|
|
Type of stroke
Hemorrhagic
|
15 Participants
n=85 Participants
|
22 Participants
n=100 Participants
|
37 Participants
n=185 Participants
|
|
Comorbidities
|
3.5 number of comorbidities present
STANDARD_DEVIATION 1.8 • n=83 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
3.5 number of comorbidities present
STANDARD_DEVIATION 2.3 • n=95 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
3.5 number of comorbidities present
STANDARD_DEVIATION 2.1 • n=178 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
|
Functional Independence Measure
|
76.1 units on a scale
STANDARD_DEVIATION 18.2 • n=85 Participants
|
79.5 units on a scale
STANDARD_DEVIATION 18.0 • n=100 Participants
|
77.9 units on a scale
STANDARD_DEVIATION 18.1 • n=185 Participants
|
|
Length of stay in inpatient rehabilitation
|
20.7 days
STANDARD_DEVIATION 16.5 • n=85 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
18.0 days
STANDARD_DEVIATION 7.8 • n=98 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
19.3 days
STANDARD_DEVIATION 12.6 • n=183 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
|
Geriatric Depression Scale - Short Form score
|
3.5 units on a scale
STANDARD_DEVIATION 2.7 • n=84 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
3.1 units on a scale
STANDARD_DEVIATION 2.8 • n=96 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
3.3 units on a scale
STANDARD_DEVIATION 2.7 • n=180 Participants • Number analyzed is lower than overall number of baseline participants due to missing data.
|
PRIMARY outcome
Timeframe: Baseline and 12 months post-strokePopulation: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
The RNLI is a disability-related quality-of life-instrument used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point scale, with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living.
Outcome measures
| Measure |
COMPASS
n=83 Participants
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
n=90 Participants
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
|---|---|---|
|
Reintegration to Normal Living Index (RNLI)
Baseline
|
60.8 score on a scale
Standard Error 2.2
|
61.2 score on a scale
Standard Error 2.2
|
|
Reintegration to Normal Living Index (RNLI)
12-month follow-up
|
74.8 score on a scale
Standard Error 2.4
|
73.9 score on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-strokePopulation: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
The SIS is a health-related quality of life (HRQoL) measure that quantifies the impact of stroke on a client's life, via questionnaire. The Activities of Daily Living (ADL) domain was used to measure daily activity performance. The scale ranges from 0 to 100, with higher scores indicating less difficulty.
Outcome measures
| Measure |
COMPASS
n=83 Participants
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
n=90 Participants
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
|---|---|---|
|
Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
Baseline
|
55.3 score on a scale
Standard Error 2.3
|
57.0 score on a scale
Standard Error 2.3
|
|
Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain
12-month follow-up
|
66.4 score on a scale
Standard Error 2.4
|
69.9 score on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-strokePopulation: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
The In-Home Occupational Performance Evaluation (I-HOPE) activity score measures current activity patterns of participants across 44 activities. The score ranges from 0 to 1.0, with a higher score indicating fewer problematic activities for the participant.
Outcome measures
| Measure |
COMPASS
n=82 Participants
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
n=89 Participants
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
Baseline
|
0.73 score on a scale
Standard Error 0.02
|
0.73 score on a scale
Standard Error 0.02
|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score
12-month follow-up
|
0.77 score on a scale
Standard Error 0.02
|
0.78 score on a scale
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-strokePopulation: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating of up to 10 participant-prioritized activities on a scale from 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty). Higher mean scores indicate better functional ability to perform tasks without difficulty.
Outcome measures
| Measure |
COMPASS
n=78 Participants
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
n=86 Participants
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
Baseline
|
2.42 score on a scale
Standard Error 0.10
|
2.65 score on a scale
Standard Error 0.09
|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score
12-month follow-up
|
3.60 score on a scale
Standard Error 0.10
|
3.44 score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and 12-months post-strokePopulation: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating of up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with their performance of the activity) to 5 (very satisfied with their performance of the activity). Higher mean scores indicate more satisfaction with self-rated activity performance.
Outcome measures
| Measure |
COMPASS
n=78 Participants
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
n=86 Participants
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
Baseline
|
2.24 score on a scale
Standard Error 0.11
|
2.53 score on a scale
Standard Error 0.11
|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score
12-month follow-up
|
3.56 score on a scale
Standard Error 0.12
|
3.33 score on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline and 12-months post-strokePopulation: Analyzed are all those included in the mixed model (excludes those with missing covariate data).
The In-Home Occupational Performance Evaluation (I-HOPE) barrier severity score is a total sum of barrier ratings (0=independent with/without a device, 1=stand-by assistance needed, 2=minimum assistance needed, 3=moderate assistance needed, 4=maximum assistance needed, 5=no activity ) for all identified barriers across up to 10 prioritized activities. Multiple barriers could be identified for each prioritized activity. Higher sum scores indicate a greater need for assistance/less independence for completion of functional activities. There is no maximum score.
Outcome measures
| Measure |
COMPASS
n=79 Participants
COMPASS is a complex intervention that combines 2 evidence-based treatment strategies at a new point of care (transition from inpatient rehabilitation). The objective of home visits by an occupational therapy (OT) practitioner is to remediate barriers in the home and community that influence daily activities and community participation. The treatment will include a set of 1 predischarge and four 75-minute postdischarge visits. The intervention is followed by 2 booster sessions.
COMPASS: The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
|
Education Program
n=86 Participants
An OT practitioner will deliver the program in accordance with "Evidence-Based Educational Guidelines for Stroke Survivors after Discharge Home." Topic order is determined by participants. Four 75-minute sessions will be provided. Topics may include stroke symptoms, risk factors and preventing stroke recurrence, nutrition, managing emotions, sleep, pain. Written materials from the National Stroke Association and the American Stroke Association are provided.
Stroke education: The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
|
|---|---|---|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
Baseline
|
67.0 score on a scale
Standard Error 3.6
|
64.4 score on a scale
Standard Error 3.5
|
|
In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score
12-month follow-up
|
30.5 score on a scale
Standard Error 3.8
|
38.4 score on a scale
Standard Error 4.1
|
Adverse Events
COMPASS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education Program
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