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CO-OPerative Training for Stroke Rehabilitation (CO-OP)

Primary Purpose

CO-OP, Attention Control

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO-OP
Attention Control
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CO-OP focused on measuring Stroke, Rehabilitation, Cognition, Intervention, Strategy training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CO-OP

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 25, 2016
Last Updated
October 5, 2017
Sponsor
University of Pittsburgh
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02755805
Brief Title
CO-OPerative Training for Stroke Rehabilitation
Acronym
CO-OP
Official Title
CO-OPerative Training For Stroke Rehabilitation: A Phase II Trial Examining Meta-Cognitive Strategy Training in Acute Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CO-OP, Attention Control
Keywords
Stroke, Rehabilitation, Cognition, Intervention, Strategy training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO-OP
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CO-OP
Other Intervention Name(s)
Strategy Training
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Other Intervention Name(s)
Reflective Listening
Primary Outcome Measure Information:
Title
Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Description
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
Secondary Outcome Measure Information:
Title
Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
Description
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
Title
Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Description
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
Title
Differences in Apathy Symptoms Between Groups Over Time
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R Skidmore, PhD, OTR/L
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share individual participant data at this time.
Citations:
PubMed Identifier
29552996
Citation
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.
Results Reference
derived

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CO-OPerative Training for Stroke Rehabilitation

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