Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation

Study Overview
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Brief Summary
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The study will administer an intervention called strategy training to adult stroke survivors living in the community who do and do not have pets, and will examine the role of a pet in promoting cognitive performance and community participation outcomes.

Official Title
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Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Strategy Training


Participation Criteria
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Eligibility Criteria
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Stroke survivors with pets Inclusion Criteria: Primary diagnosis of acute stroke At least 3 months after the stroke onset Living in a community residence with a pet Cognitive impairment as indicated by an Executive Interview score of 3 or higher Participation restrictions as indicated by an Activity Card Sort (<80% of pre-stroke activities) Willing to participate in a 6-week program with 2 intervention sessions per week at home Exclusion Criteria: Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1 Self-report of a central nervous system disorder other than stroke Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview Severe mental illness as indicated by the PRIME-MD Prior exposure to strategy training Currently participate in rehabilitation therapy programs Stroke survivors without pets Inclusion Criteria: Primary diagnosis of acute stroke At least 3 months after the stroke onset Living in a community residence Cognitive impairment as indicated by an Executive Interview score of 3 or higher Participation restrictions as indicated by an Activity Card Sort (<80% of pre-stroke activities) Willing to participate in a 6-week program with 2 intervention sessions per week at home Exclusion Criteria: Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1 Self-report of a central nervous system disorder other than stroke Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview Severe mental illness as indicated by the PRIME-MD Prior exposure to strategy training Currently participate in rehabilitation therapy programs

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed study is a single site, two-group quasi-experimental design comparing the effects of strategy training on rehabilitation engagement, cognitive performance, and community participation of home-dwelling stroke survivors living with and without pets. The investigators will also conduct qualitative interviews with participants who have pets.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke survivors with pets<br>Stroke survivors with pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home. | Behavioral: Strategy Training<br>* Strategy training is comprised of participant-selected activity based goals, self evaluation, global problem solving strategies, and therapist-delivered guided training. The strategy training therapist will guide participants using prompting questions, as well as work sheets that facilitate learning and aid the participants in implementing the process.<br>|
| Active Comparator: Stroke survivors without pets<br>Stroke survivors without pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home. | Behavioral: Strategy Training<br>* Strategy training is comprised of participant-selected activity based goals, self evaluation, global problem solving strategies, and therapist-delivered guided training. The strategy training therapist will guide participants using prompting questions, as well as work sheets that facilitate learning and aid the participants in implementing the process.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale | The scale is a valid and reliable criterion referenced measure that assesses engagement in rehabilitation therapy sessions. Each session is scored by the occupational therapist, 1 (no participation, refusal) to 6 (excellent participation). Scores are averaged across the 10-15 intervention sessions to generate the mean engagement score. | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in attention as measured by the Color Trail Test 1 | This measure assesses perceptual tracking, sustained attention and grapho-motor skills. It is a pencil and paper, timed test. Completion time in seconds for each task is recorded, with a lower score representing better function. Change in attention will be calculated by subtracting the time to do the task at baseline from the time to do the task at 3 months. | Baseline to 3 months | 
| Change in executive function as measured by the Color Trail Test 2 | This measure assesses divided attention and sequencing skills, which are executive function performance. It is a pencil and paper, timed test of effortful executive processing abilities that assesses the ability to alternate between two colors. Completion time in seconds for each task is recorded, with a lower score representing better function. Change in executive function will be calculated by subtracting the time to do the task at baseline from the time to do the task at 3 months. | Baseline to 3 months | 
| Change in community participation as measure by Community Participation Indicators score | This participant reported questionnaire will measure the frequency of community participation over a 7 days period. Each item is measured on a 5-point Likert scale, with 1=no participation in that activity and 5=7 days of participation in that activity. A total of 20 items are summed to yield a total score. Change in community participation will be calculated by subtracting baseline total score from the 3 month total score. | Baseline to 3 months |