NCT02724813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

February 9, 2016

Last Update Submit

February 22, 2018

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

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)

Wait-list arm

ACTIVE COMPARATOR

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)

Interventions

Cognitive Orientation to Occupational Preformance (COOP)BEHAVIORAL
Intervention armWait-list arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of dementia
  • Severe concurrent depression
  • Severe aphasia
  • Concurrent substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (1)

  • Dawson DR, Anderson ND, Binns M, Bar Y, Chui A, Gill N, Linkewich E, McEwen S, Nalder E, Skidmore E. Strategy-training post-stroke via tele-rehabilitation: a pilot randomized controlled trial. Disabil Rehabil. 2024 Jan;46(1):67-76. doi: 10.1080/09638288.2022.2154397. Epub 2022 Dec 14.

    PMID: 36524387DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Deirdre Dawson, PhD

    Baycrest Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

February 9, 2016

First Posted

March 31, 2016

Study Start

November 1, 2015

Primary Completion

September 30, 2017

Study Completion

December 1, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)