Tele-Rehabilitation Study for People With a History of Stroke

Study Overview
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Brief Summary
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Stroke results in long-term disability for many people, and particularly for survivors of stroke who have cognitive impairments. However, a decreasing proportion of stroke patients are able to access or receive publicly funded rehabilitation. The investigators have shown in previous studies that in-person delivery of the Cognitive Orientation to daily Occupational Performance (CO-OP) rehabilitation approach to promoting attainment of everyday life goals has resulted in improvements in functional independence and executive function. In a small pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI) (n=3), the investigators found the delivery method was feasible and that participants were satisfied with the treatment and demonstrated clinically significant improvements on personally meaningful activities. The investigators will investigate the feasibility, preliminary efficacy, and cost-effectiveness of delivering CO-OP in an online format to reduce disability post-stroke. The study design is a single-blind (assessor), randomized wait-list control trial with a one-month retention follow-up. All therapy and testing sessions will be delivered online. We hypothesize that participants will demonstrate improvement in everyday activities and community participation.

Official Title
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Tele-rehabilitation for Cognitive Disability Post Stroke: Enhancing Function in the Face of Geographical Disparities

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Cognitive Orientation to Occupational Preformance (COOP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling adults at least three months post-stroke Fluent in written and spoken English Impairment of executive cognitive functions Ability to self-identify specific areas of difficulty in their everyday life that they would like to improve Access to a computer or tablet with a high-speed internet connection Exclusion Criteria: Presence of dementia Severe concurrent depression Severe aphasia Concurrent substance abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Intervention arm<br>Participants will receive 16 one-hour tele-CO-OP sessions delivered over a 10-week period by a licensed health care professional. We will deliver tele-CO-OP via Skype™ and record all sessions using Pamela software for Skype™. | Behavioral: Cognitive Orientation to Occupational Preformance (COOP)<br> <br> |
| Active Comparator: Wait-list arm<br>Participant in this arm will receive therapy 8 weeks after initial assessment. Participants will receive 16 one-hour tele-CO-OP sessions delivered over a 10-week period by a licensed health care professional. We will deliver tele-CO-OP via Skype™ and record all sessions using Pamela software for Skype™. | Behavioral: Cognitive Orientation to Occupational Preformance (COOP)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Canadian Occupational Performance Measure (COPM) | The COPM is a standardized, semi-structured interview that facilitates goal identification and has been used as the primary outcome measure for many of the CO-OP studies | 10 weeks and 14 weeks | 
| Changes in Reintegration to Normal Living Index (RNL) | The RNL is a measure of satisfaction with participation in everyday life | 10 weeks and 14 weeks |