Tele-Rehabilitation Study for People With a History of Stroke

Sponsor
Baycrest (Other)
Overall Status
Completed
CT.gov ID
NCT02724813
Collaborator
Health and Stroke Foundation-Canadian Partnership for Stroke recovery (Other)
24
1
2
25
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Orientation to Occupational Preformance (COOP)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
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
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Deirdre Dawson, Senior Scientist, Baycrest
ClinicalTrials.gov Identifier:
NCT02724813
Other Study ID Numbers:
  • REB#15-37
First Posted:
Mar 31, 2016
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2018