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Tele-Rehabilitation Study for People With a History of Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02724813
First Posted: March 31, 2016
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Health and Stroke Foundation-Canadian Partnership for Stroke recovery
Information provided by (Responsible Party):
Dr. Deirdre Dawson, Baycrest
  Purpose
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.

Condition Intervention
Stroke Behavioral: Cognitive Orientation to Occupational Preformance (COOP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tele-rehabilitation for Cognitive Disability Post Stroke: Enhancing Function in the Face of Geographical Disparities

Resource links provided by NLM:


Further study details as provided by Dr. Deirdre Dawson, Baycrest:

Primary Outcome Measures:
  • Changes in Canadian Occupational Performance Measure (COPM) [ Time Frame: 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) [ Time Frame: 10 weeks and 14 weeks ]
    The RNL is a measure of satisfaction with participation in everyday life


Estimated Enrollment: 24
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention arm
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)
Active Comparator: Wait-list arm
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724813


Locations
Canada, Ontario
Baycrest Health Sciences
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
Baycrest
Health and Stroke Foundation-Canadian Partnership for Stroke recovery
Investigators
Principal Investigator: Deirdre Dawson, PhD Baycrest Health Sciences
  More Information

Responsible Party: Dr. Deirdre Dawson, Senior Scientist, Baycrest
ClinicalTrials.gov Identifier: NCT02724813     History of Changes
Other Study ID Numbers: REB#15-37
First Submitted: February 9, 2016
First Posted: March 31, 2016
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases