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Tele-Rehabilitation Study for People With a History of Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Orientation to Occupational Preformance (COOP)
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baycrest Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Wait-list arm

Arm Description

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™.

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™.

Outcomes

Primary Outcome Measures

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
Changes in Reintegration to Normal Living Index (RNL)
The RNL is a measure of satisfaction with participation in everyday life

Secondary Outcome Measures

Full Information

First Posted
February 9, 2016
Last Updated
February 22, 2018
Sponsor
Baycrest
Collaborators
Health and Stroke Foundation-Canadian Partnership for Stroke recovery
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1. Study Identification

Unique Protocol Identification Number
NCT02724813
Brief Title
Tele-Rehabilitation Study for People With a History of Stroke
Official Title
Tele-rehabilitation for Cognitive Disability Post Stroke: Enhancing Function in the Face of Geographical Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest
Collaborators
Health and Stroke Foundation-Canadian Partnership for Stroke recovery

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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™.
Arm Title
Wait-list arm
Arm Type
Active Comparator
Arm Description
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™.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Orientation to Occupational Preformance (COOP)
Primary Outcome Measure Information:
Title
Changes in Canadian Occupational Performance Measure (COPM)
Description
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
Time Frame
10 weeks and 14 weeks
Title
Changes in Reintegration to Normal Living Index (RNL)
Description
The RNL is a measure of satisfaction with participation in everyday life
Time Frame
10 weeks and 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deirdre Dawson, PhD
Organizational Affiliation
Baycrest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tele-Rehabilitation Study for People With a History of Stroke

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