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Stroke is one of the most serious, disabling health conditions in the United States. Patients who undergo rehabilitation treatment for stroke have a high rate of disability. Poor outcomes for many persons with stroke may be low because of incomplete treatment. The investigators will conduct a randomized controlled trial and a process evaluation to examine the feasibility, safety, and preliminary efficacy of an enhanced rehabilitation transition program, Community Participation Transition after Stroke (COMPASS), designed to bridge inpatient rehabilitation and the home to support the performance of everyday activities.
We propose an enhanced rehabilitation transition program: Community Participation Transition after Stroke (COMPASS) is a compensatory intervention consisting of one pre-discharge and five post-discharge home visits by an occupational therapist to supplement usual care. This intervention is focused on resolving barriers to independence in daily activities and participation using environmental support and active practice of daily activities in an individual's real home (versus an idealized clinical setting). This is a new combination of evidence-based compensatory treatments delivered in a novel treatment setting (transition to home). Our long-term goal is the development of an effective intervention for a transition home designed to prevent excess disability for people living with stroke that could have an immediate effect and high public health significance.16
We will recruit 40 patients currently undergoing inpatient rehabilitation (IR) for ischemic stroke from longitudinal studies of stroke at Washington University School of Medicine (WUSM) and randomize them to receive six additional sessions of the enhanced rehabilitation transition program or attention control. Exploratory participation outcomes will be assessed by blinded evaluators at baseline, 6 months, 9 months, and 12 months after stroke.
We will test the central hypothesis that COMPASS will be acceptable, feasible, and superior to attention control on measures of participation and daily activity performance at 6 months after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Group | Active Comparator | Participants in the Education group receive five 90 minute tailored stroke education sessions in the home. |
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| Home Modifications Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and Severity of Falls (Calculated With an Algorithm) | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Dose (Minutes) | 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. | 2 months |
| Health Care Utilization, Number of Emergency Department Visits |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Adherence | 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. | 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan L Stark, PhD | Washington University School of Medicine, Program in Occupational Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Intervention |
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| 6 Month Follow-up |
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| 9 Month Follow-up |
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| 12 Month Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| 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, Categorical | Count of Participants |
| 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 | Rate and Severity of Falls (Calculated With an Algorithm) | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment | Participants were asked "How many hospitalizations have you had in the past 6 months?" and were able to self-report. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Stark | Washington University in St. Louis School of Medicine | 3142734114 | sstark@wustl.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Home Modifications Group | Behavioral | 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. |
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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. |
| 12 months |
| Intervention Dose, Number of Treatment Sessions | 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. | 2 months |
| Health Care Utilization, Days of Hospitalization | 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. | 12 months |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| 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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| Region of Enrollment | Number | participants |
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| Length of Stay in Inpatient Rehabilitation | Length of stay is a clinical metric that measures the length of time elapsed between a patient's date of admission and discharge. | Mean | Standard Deviation | days |
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| Stroke Impact Scale (SIS) Total | The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. We are using the 10 items from the Activities of Daily Living / Instrumental Activities of Daily Living (ADL/IADL) domain. Clients also rate their overall recovery on a scale of 0 - 100, 0 indicating no recovery, 100 full recovery. | Mean | Standard Deviation | units on a scale |
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| Reintegration to Normal Living Index (RNLI) | The RNLI measure the extent to which a person is able to resume normal life activities after illness or injury. The 11 items questionnaire asks about one's daily functioning and perception of self. Questions are scored on a scale of 1 to 10, with a 1 indicating the statement "does not describe my situation" and a 10 indicating the statement "fully describes my situation". Scores are summed for a total score out of 110 points which is then converted to an adjusted score with a range of 0-100. A higher score indicates higher attainment of normal levels of living. Scores reported are adjusted. | Mean | Standard Deviation | units on a scale |
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| SIS Activity of Daily Living (ADL) Subscale | The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. We are using the 10 items from the Activities of Daily Living / Instrumental Activities of Daily Living (ADL/IADL) domain. Each item is rated using a 5-point Likert scale, with a 1 indicating an inability to complete the activity and a 5 indicating no difficulty experienced at all. Domain scores range from 0-100 and are calculated using the following equation = [(Mean item score - 1) / 5-1 ] x 100. | Mean | Standard Deviation | units on a scale |
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| In-Home Occupational Performance Measure (I-HOPE) Performance | The I-HOPE is a multi-step assessment that evaluates performance of older adults doing 42 activities in the home. It measures current activity patterns of participants, identifies activities that are difficult but important to them, and identifies environmental barriers that influence those activities. Participants rate their performance of top 10 desired activities on a scale of 1-5, with 1=no performance and 5=perfect performance. A sum (score range 10-50) and mean score (range 1-5) are calculated for all 10 activities. Scores reported are sum scores. Higher sum scores= better performance. | Mean | Standard Deviation | units on a scale |
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| I-HOPE Satisfaction | The I-HOPE is a multi-step assessment evaluating performance of older adults for 42 activities in the home. It measures activity patterns of participants, identifies activities that are difficult but important to them, and identifies environmental barriers influencing those activities. Participants rate their satisfaction with their ability to perform each problematic activity on a scale of 1-5, with 1=not satisfied at all, and 5= totally satisfied. A sum (range 10-50) and mean score (range 1-5) are calculated for all 10 activities. Sum scores are reported. Higher scores=greater satisfaction. | Mean | Standard Deviation | units on a scale |
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| I-HOPE Environmental Barriers | The I-HOPE is a multi-step assessment that evaluates the performance of older adults doing 42 activities in the home. The I-HOPE measures current activity patterns of participants, identifies activities that are difficult but important, and identifies environmental barriers that influence activity performance. The barrier scores is an objective score of the impact of the environment on ability to perform daily activities. Barriers scores range from 0, no impact on performance to 5, total impact on performance. Higher barrier scores indicate worse performance. Barriers scores are summed. | Mean | Standard Deviation | barrier score |
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| 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. |
| OG001 | 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. |
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| Secondary | Intervention Dose (Minutes) | 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. | 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. | Posted | Mean | Standard Deviation | number of treatment minutes | 2 months |
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| Secondary | Health Care Utilization, Number of Emergency Department Visits | 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. | 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. | Posted | Mean | Standard Deviation | Number of visits | 12 months |
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| Secondary | Intervention Dose, Number of Treatment Sessions | 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. | 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. | Posted | Mean | Standard Deviation | number of treatment sessions | 2 months |
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| Secondary | Health Care Utilization, Days of Hospitalization | 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. | 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. | Posted | Mean | Standard Deviation | days | 12 months |
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| Other Pre-specified | Intervention Adherence | 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. | 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. | Posted | Mean | Standard Deviation | percentage of recommendations used | 9 months |
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| EG001 | 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. | 1 | 9 | 0 | 9 | 0 | 9 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Outpatient occupational therapy visits |
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| Outpatient doctor visits |
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