CO-OP, Attention Control
Conditions
Keywords
Stroke, Rehabilitation, Cognition, Intervention, Strategy training
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCO-OP
BEHAVIORALAttention Control
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary diagnosis of acute stroke * admission to acute inpatient rehabilitation * impairment in cognitive functions (Quick Executive Interview ≥ 3)
Exclusion criteria
* dementia diagnosis (as indicated in the medical record) * severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3) * current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders) * drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview) * anticipated length of stay less than 5 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Baseline, rehabilitation discharge, month 3, month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Baseline, 3 months, 6 months | 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. |
| Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Baseline, 3 months, 6 months | 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. |
| Differences in Apathy Symptoms Between Groups Over Time | Baseline, 3 months, 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: July 2009 to June 2012. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.
Pre-assignment details
Excluded (n=30): * Insufficient cognitive impairment (n=15) * Mood/psychotic disorder (n=5) * Aphasia (n=3) * Recent drug/alcohol abuse (n=2) * Primary diagnosis not stroke (n=2) Withdrew prior to randomization (n=3) * Changed mind (n=1) * Family reasons (n=1) * Unexpected discharge (n=1)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Refused assessments | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | CO-OP | Attention Control | Total |
|---|---|---|---|
| Age, Continuous | 64.87 years STANDARD_DEVIATION 16.59 | 71.80 years STANDARD_DEVIATION 13.19 | 67.33 years STANDARD_DEVIATION 15.41 |
| Apathy, AES | 25.79 units on a scale STANDARD_DEVIATION 7.62 | 25.18 units on a scale STANDARD_DEVIATION 4.4 | 25.52 units on a scale STANDARD_DEVIATION 6.29 |
| Cognitive flexibility, CWI (Color Word Interference) | 3.69 units on a scale STANDARD_DEVIATION 2.36 | 2.73 units on a scale STANDARD_DEVIATION 2.34 | 3.18 units on a scale STANDARD_DEVIATION 2.36 |
| Cognitive status, EXIT (Quick Executive Interview) | 8.13 units on a scale STANDARD_DEVIATION 3 | 9.31 units on a scale STANDARD_DEVIATION 3.54 | 8.72 units on a scale STANDARD_DEVIATION 3.28 |
| Communication status, BDAE (Boston Diagnositic Aphasia Examination Severity Index) | 4.27 units on a scale STANDARD_DEVIATION 1.03 | 4.67 units on a scale STANDARD_DEVIATION 0.62 | 4.47 units on a scale STANDARD_DEVIATION 0.86 |
| Depressive symptoms, HamD (Hamilton Rating Scale for Depression) | 6.71 units on a scale STANDARD_DEVIATION 4.36 | 6.75 units on a scale STANDARD_DEVIATION 4.53 | 6.73 units on a scale STANDARD_DEVIATION 4.35 |
| Functional Independence Measure | 65.27 units on a scale STANDARD_DEVIATION 10.85 | 62.60 units on a scale STANDARD_DEVIATION 16.56 | 63.93 units on a scale STANDARD_DEVIATION 13.82 |
| Hemisphere left | 5 participants | 5 participants | 10 participants |
| Hemisphere right | 10 participants | 10 participants | 20 participants |
| Inhibition, CWI (Color Word Interference) | 4.85 units on a scale STANDARD_DEVIATION 4.1 | 4.00 units on a scale STANDARD_DEVIATION 2.98 | 4.39 units on a scale STANDARD_DEVIATION 3.5 |
| Medical burden, CIRS (Cumulative Illness Rating Scale) | 2.37 units on a scale STANDARD_DEVIATION 0.47 | 2.36 units on a scale STANDARD_DEVIATION 0.57 | 2.37 units on a scale STANDARD_DEVIATION 0.53 |
| Race/Ethnicity, Customized African American | 3 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized White | 12 participants | 14 participants | 26 participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
| Stroke onset | 16.80 days STANDARD_DEVIATION 15.58 | 18.47 days STANDARD_DEVIATION 21.29 | 17.63 days STANDARD_DEVIATION 18.35 |
| Stroke severity, NIHSS (National Institutes of Health Stroke Scale) | 8.87 units on a scale STANDARD_DEVIATION 2.77 | 5.87 units on a scale STANDARD_DEVIATION 2.72 | 7.37 units on a scale STANDARD_DEVIATION 3.1 |
| Stroke type hemorrhagic | 5 participants | 4 participants | 9 participants |
| Stroke type ischemic | 10 participants | 11 participants | 21 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Baseline, rehabilitation discharge, month 3, month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CO-OP | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Discharge Scores | 86.80 units on a scale | Standard Error 3.27 |
| CO-OP | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 3 | 109.69 units on a scale | Standard Error 2.61 |
| CO-OP | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 6 | 113.31 units on a scale | Standard Error 2.48 |
| CO-OP | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Baseline Scores | 65.27 units on a scale | Standard Error 2.8 |
| Attention Control | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Baseline Scores | 62.60 units on a scale | Standard Error 4.28 |
| Attention Control | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Discharge Scores | 80.53 units on a scale | Standard Error 5.73 |
| Attention Control | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 6 | 95.27 units on a scale | Standard Error 7.6 |
| Attention Control | Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Month 3 | 91.23 units on a scale | Standard Error 7.48 |
Comparison: All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.p-value: 0.007Mixed Models Analysis
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.
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CO-OP | Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Month 3 Scores | 8.82 units on a scale | Standard Error 0.81 |
| CO-OP | Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Month 6 Scores | 8.20 units on a scale | Standard Error 0.73 |
| CO-OP | Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Baseline Scores | 3.69 units on a scale | Standard Error 0.65 |
| Attention Control | Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Baseline Scores | 2.73 units on a scale | Standard Error 0.61 |
| Attention Control | Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Month 3 Scores | 3.00 units on a scale | Standard Error 0.93 |
| Attention Control | Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) | Month 6 Scores | 2.78 units on a scale | Standard Error 0.93 |
Comparison: All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.p-value: 0.002Mixed Models Analysis
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.
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CO-OP | Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Month 6 Scores | 8.20 units on a scale | Standard Error 1.13 |
| CO-OP | Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Baseline Scores | 4.85 units on a scale | Standard Error 1.14 |
| CO-OP | Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Month 3 Scores | 8.73 units on a scale | Standard Error 3 |
| Attention Control | Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Baseline Scores | 4.00 units on a scale | Standard Error 0.77 |
| Attention Control | Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Month 3 Scores | 4.40 units on a scale | Standard Error 1.37 |
| Attention Control | Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) | Month 6 Scores | 3.67 units on a scale | Standard Error 1.11 |
Comparison: All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.p-value: 0.09Mixed Models Analysis
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.
Time frame: Baseline, 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CO-OP | Differences in Apathy Symptoms Between Groups Over Time | Baseline Scores | 25.79 units on a scale | Standard Error 2.04 |
| CO-OP | Differences in Apathy Symptoms Between Groups Over Time | Month 3 Scores | 25.18 units on a scale | Standard Error 1.65 |
| CO-OP | Differences in Apathy Symptoms Between Groups Over Time | Month 6 Scores | 21.38 units on a scale | Standard Error 1.34 |
| Attention Control | Differences in Apathy Symptoms Between Groups Over Time | Baseline Scores | 25.18 units on a scale | Standard Error 1.32 |
| Attention Control | Differences in Apathy Symptoms Between Groups Over Time | Month 3 Scores | 34.13 units on a scale | Standard Error 4.7 |
| Attention Control | Differences in Apathy Symptoms Between Groups Over Time | Month 6 Scores | 29.00 units on a scale | Standard Error 4.82 |
Comparison: All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.p-value: 0.04repeated measures fixed effects model