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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD092398-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study evaluates a program designed to help individuals transition home from inpatient rehabilitation following an ischemic or hemorrhagic stroke. Half of the participants will receive a stroke education program while the other half will receive an environmental modifications program.
A gap in care exists at the point of transition from inpatient rehabilitation (IR) to home, when survivors encounter new environmental barriers due to the cognitive and sensorimotor sequelae of stroke. Resolving these barriers and improving independence in the community have potential to significantly improve stroke survivors' long-term morbidity. The proposed study investigates the efficacy and safety of a novel enhanced rehabilitation-transition program to reduce environmental barriers and improve daily activity performance and community participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMPASS | Experimental | 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. |
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| Education program | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMPASS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reintegration to Normal Living Index (RNLI) | 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. | Baseline and 12 months post-stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain | 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. | Baseline and 12 months post-stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Stark, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39773227 | Derived | Krauss MJ, Somerville E, Poiter C, Bollinger RM, Holden BM, Blenden G, Kretzer D, Stark SL. Functional performance of patients with stroke during inpatient rehabilitation: a cross-sectional study of home and access visits. BMC Health Serv Res. 2025 Jan 7;25(1):34. doi: 10.1186/s12913-024-12167-6. | |
| 39374016 | Derived | Bollinger RM, Krauss MJ, Somerville EK, Holden BM, Blenden G, Hollingsworth H, Keleman AA, Carter A, McBride TD, Barker AR, Yan Y, Stark SL. Rehabilitation Transition Program to Improve Community Participation Among Stroke Survivors: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2437758. doi: 10.1001/jamanetworkopen.2024.37758. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Reintegration to Normal Living Index (RNLI) | 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. | Analyzed are all those included in the mixed model (excludes those with missing covariate data). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 12 months post-stroke |
|
1 year post-stroke
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susy Stark | Washington University in St. Louis | 3142734114 | sstark@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2023 | Sep 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Single-blind, parallel-group, randomized controlled trial
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| Stroke education | Behavioral | 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 | 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. | Baseline and 12 months post-stroke |
| In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score | 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. | Baseline and 12 months post-stroke |
| In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score | 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. | Baseline and 12-months post-stroke |
| In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score | 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. | Baseline and 12-months post-stroke |
| 38772517 | Derived | Krauss MJ, Holden BM, Somerville E, Blenden G, Bollinger RM, Barker AR, McBride TD, Hollingsworth H, Yan Y, Stark SL. Community Participation Transition After Stroke (COMPASS) Randomized Controlled Trial: Effect on Adverse Health Events. Arch Phys Med Rehabil. 2024 Sep;105(9):1623-1631. doi: 10.1016/j.apmr.2024.05.015. Epub 2024 May 19. |
| 31577356 | Derived | Somerville E, Minor B, Keglovits M, Yan Y, Stark S. Effect of a Novel Transition Program on Disability After Stroke: A Trial Protocol. JAMA Netw Open. 2019 Oct 2;2(10):e1912356. doi: 10.1001/jamanetworkopen.2019.12356. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital status | Count of Participants | Participants |
|
| Living situation | Count of Participants | Participants |
|
| Type of stroke | Count of Participants | Participants |
|
| Comorbidities | Number of comorbidities | Number analyzed is lower than overall number of baseline participants due to missing data. | Mean | Standard Deviation | number of comorbidities present |
|
| Functional Independence Measure | Measurement for disability. 18 items assess six areas of function in motor ability and cognition. Final summed score ranges from 18-126: 18 represents complete dependence/total assistance, 126 represents complete independence. | Mean | Standard Deviation | units on a scale |
|
| Length of stay in inpatient rehabilitation | Number analyzed is lower than overall number of baseline participants due to missing data. | Mean | Standard Deviation | days |
|
| Geriatric Depression Scale - Short Form score | 15 items assess depression among older adults. Sum score ranges from 0-15; Score >5 points is suggestive of depression. Higher scores indicate higher likelihood of depression. | Number analyzed is lower than overall number of baseline participants due to missing data. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| Secondary | Stroke Impact Scale (SIS) - Activities of Daily Living (ADL) Domain | 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. | Analyzed are all those included in the mixed model (excludes those with missing covariate data). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 12 months post-stroke |
|
|
|
|
| Secondary | In-Home Occupational Performance Evaluation (I-HOPE) - Activity Score | 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. | Analyzed are all those included in the mixed model (excludes those with missing covariate data). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 12 months post-stroke |
|
|
|
|
| Secondary | In-Home Occupational Performance Evaluation (I-HOPE) - Performance Score | 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. | Analyzed are all those included in the mixed model (excludes those with missing covariate data). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 12 months post-stroke |
|
|
|
|
| Secondary | In-Home Occupational Performance Evaluation (I-HOPE) - Satisfaction Score | 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. | Analyzed are all those included in the mixed model (excludes those with missing covariate data). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 12-months post-stroke |
|
|
|
|
| Secondary | In-Home Occupational Performance Evaluation (I-HOPE) - Barrier Severity Score | 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. | Analyzed are all those included in the mixed model (excludes those with missing covariate data). | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 12-months post-stroke |
|
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | 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. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Not listed |
|
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |