Tele-Rehabilitation Study for People With a History of Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Cognitive Orientation to Occupational Preformance (COOP)

• Registration Number: NCT02724813
• Lead Sponsor: Baycrest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-03-31
• Primary Completion: 2017-09-30
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Cognitive Orientation to Occupational Preformance (COOP)	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™.
Wait-list arm	Cognitive Orientation to Occupational Preformance (COOP)	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™.

Primary Outcome Measures

Name	Time	Method
Changes in Canadian Occupational Performance Measure (COPM)	10 weeks and 14 weeks	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
Changes in Reintegration to Normal Living Index (RNL)	10 weeks and 14 weeks	The RNL is a measure of satisfaction with participation in everyday life

Trial Locations

Locations (1)

Baycrest Health Sciences; 🇨🇦 Toronto, Ontario, Canada