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| ID | Type | Description | Link |
|---|---|---|---|
| K12HD055931 | 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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Cognitive impairments occur frequently after stroke, and are associated with significant long-term activities of daily living (ADL) disability and poor quality of life. This research study will undertake an innovative approach addressing cognitive impairments, by examining a new patient-centered functionally-relevant rehabilitation intervention that teaches individuals with cognitive impairments to manage their deficits to reduce ADL disability.
Cognitive impairments are characterized by problems sustaining attention in distracting conditions, shifting attention between different task demands, and using working memory to consistently execute intended actions, and as a result limit the ability to execute routine ADLs. Presently there are no interventions that have demonstrated robust effectiveness in reducing disability among individuals with cognitive impairments after stroke. Recent findings suggest that individuals with cognitive impairments may experience ADL disability in part because they have difficulty engaging in, and benefiting from rehabilitation programs as they are currently delivered. In other words, individuals with cognitive impairment, due to the nature of their impairments, have difficulty learning and applying adaptive strategies as they are currently provided during traditional rehabilitation training. Therefore, interventions that train individuals with cognitive impairments a new way to learn and apply adaptive strategies may help them benefit from rehabilitation programs and reduce long-term disability. Cognitive Orientation to daily Occupation Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Therefore, CO-OP teaches individuals to "take charge" of their rehabilitation, and develop adaptive behaviors to "work around" cognitive impairments to meet their goals. The proposed project examines whether CO-OP facilitates reductions in ADL disability and improvements in rehabilitation engagement among individuals with cognitive impairments after acute stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO-OP | Experimental | Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training. |
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| Attention Control | Placebo Comparator | The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO-OP | Behavioral |
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| Attention Control |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point. | Baseline, rehabilitation discharge, month 3, month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models. The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth R Skidmore, PhD, OTR/L | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29552996 | Derived | Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19. |
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There is no current plan to share individual participant data at this time.
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Excluded (n=30):
Withdrew prior to randomization (n=3)
Recruitment period: July 2009 to June 2012. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | CO-OP | Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training. CO-OP |
| FG001 | Attention Control | The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities. Attention Control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CO-OP | Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training. CO-OP |
| 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, 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 | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point. | Posted | Mean | Standard Error | units on a scale | Baseline, rehabilitation discharge, month 3, month 6 |
|
6 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 | CO-OP | Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training. CO-OP |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth R. Skidmore, PhD, OTR/L, FAOTA | University of Pittsburgh | (412) 383-6617 | skidmore@pitt.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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| Behavioral |
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| Baseline, 3 months, 6 months |
| Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models. The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point. | Baseline, 3 months, 6 months |
| Differences in Apathy Symptoms Between Groups Over Time | Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models. The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point. | Baseline, 3 months, 6 months |
| Withdrawal by Subject |
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| BG001 | Attention Control | The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities. Attention Control |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Stroke onset | Stroke onset is calculated from date of stroke to date of study admission. | Mean | Standard Deviation | days |
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| Stroke type | Number | participants |
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| Hemisphere | Number | participants |
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| Stroke severity, NIHSS (National Institutes of Health Stroke Scale) | The NIHSS is composed of 11 items that are summed to yield a total score. Total scores range from 0 to 42; 0=no neurological impairment, 42=severe neurological impairment. | Mean | Standard Deviation | units on a scale |
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| Medical burden, CIRS (Cumulative Illness Rating Scale) | The Cumulative Illness Rating Scale records medical problems for 14 organ systems. The severity index is computed by averaging the impairment severity for each organ system (0=no impairment, 4=severe impairment), yielding an average severity index of 0 (no medical problems) to 4 (severe medical problems). | Mean | Standard Deviation | units on a scale |
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| Cognitive status, EXIT (Quick Executive Interview) | The EXIT is composed of 14 items that are summed to yield a total score ranging from 0 to 28. A total score of 0 typically indicates no executive impairment, while a total score of 28 indicates severe executive impairment. | Mean | Standard Deviation | units on a scale |
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| Communication status, BDAE (Boston Diagnositic Aphasia Examination Severity Index) | The Boston Diagnostic Aphasia Examination is an aphasia severity rating scale ranging from 0-5, with 0 representing no usable speech or auditory comprehension and 5 representing minimal discernible speech impairments. | Mean | Standard Deviation | units on a scale |
|
| Functional Independence Measure | The Functional Independence Measure contains 18 items composed of 13 motor tasks and 5 cognitive tasks. A total scores is obtained (18-126), 18 represents complete dependence/total assistance and 126 represents complete independence with daily activities. | Mean | Standard Deviation | units on a scale |
|
| Inhibition, CWI (Color Word Interference) | The Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. | Mean | Standard Deviation | units on a scale |
|
| Cognitive flexibility, CWI (Color Word Interference) | The Cognitive Flexibility Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. | Mean | Standard Deviation | units on a scale |
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| Depressive symptoms, HamD (Hamilton Rating Scale for Depression) | The Hamilton Depression Rating Scale is composed of 17 items that are summed to yield a total score ranging from 0 to 52. A total score of 0 typically indicates no depressive symptoms; 52 indicates severe depressive symptoms. | Mean | Standard Deviation | units on a scale |
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| Apathy, AES | The Apathy Evaluation Scale measures motivation or interest in goal-directed activities. The scale has 18 items with a total score of 18 (absence of apathy) to 72 (severe apathy). | Mean | Standard Deviation | units on a scale |
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| OG001 | Attention Control | The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities. Attention Control |
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| Secondary | Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models. The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point. | Posted | Mean | Standard Error | units on a scale | Baseline, 3 months, 6 months |
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| Secondary | Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models. The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point. | Posted | Mean | Standard Error | units on a scale | Baseline, 3 months, 6 months |
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| Secondary | Differences in Apathy Symptoms Between Groups Over Time | Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models. The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point. | Posted | Mean | Standard Error | units on a scale | Baseline, 3 months, 6 months |
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| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Attention Control | The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities. Attention Control | 0 | 15 | 0 | 15 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Month 6 Scores |
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| Month 6 Scores |
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| Month 6 Scores |
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