Adapting Daily Activity Performance Through Strategy Training

Study Overview
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Brief Summary
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Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.

Official Title
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Closing the Gap: Early Intervention for Cognitive Disability After Stroke

Conditions
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Strategy Training, Attention Control

Intervention / Treatment
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* Behavioral: Strategy Training
* Behavioral: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary diagnosis of acute stroke admission to acute inpatient rehabilitation impairment in higher order cognitive functions (EXIT-14 ≥ 3) Exclusion Criteria: pre-stroke diagnosis of dementia in the medical record inability to follow two- step commands 80% of the time severe aphasia (BDAE ≤ 1) current major depressive, bipolar, or psychotic disorder drug or alcohol abuse within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strategy Training<br>Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Participants use printed workbooks to learn and apply this method. | Behavioral: Strategy Training<br> <br> |
| Placebo Comparator: Attention Control<br>The attention control intervention will control for the non-specific effects of strategy training. The therapists will administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. In lieu of the strategy training workbook materials, participants will complete a daily journal, and discuss their entries during attention control sessions. | Behavioral: Attention Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Independence with Daily Activities | Moderate effect size of difference between groups in independence (measured with the Functional Independence Measure) | Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Executive Functions | Moderate effect size of difference between groups in independence (measured with selected indices of the Delis-Kaplan Executive Function System) | Baseline to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Rehabilitation, Cognition, Disability