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Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment (CO-OP_KT)

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ClinicalTrials.gov Identifier: NCT02597569
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : September 20, 2018
Sponsor:
Collaborators:
University of Toronto
University Health Network, Toronto
West Park Healthcare Centre
Sinai Health System
Providence HealthCare
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:

Patients with cognitive impairments following a stroke are often denied access to inpatient rehabilitation, despite evidence of its benefits for them. Patients with cognitive impairment who are admitted to inpatient stroke rehabilitation often receive services based on outdated impairment-reduction models, rather than recommended function-based approaches. These two issues, reduced access to rehabilitation and the knowledge-to-practice gap, both stem from a reported lack of skills and knowledge on the part of some stroke rehabilitation teams to foster recovery in people with cognitive impairments. To address these issues, the investigators will implement and evaluate a multi-faceted, supported, integrated knowledge translation initiative, targeted specifically at the inter-professional application of the Cognitive Orientation to daily Occupational Performance (CO-OP), called CO-OP KT. CO-OP is a contemporary, effective, cognitive strategy-based treatment approach. CO-OP KT is a combination of the CO-OP Approach with multi-faceted knowledge translation support. Clinical staff at participating institutions will receive CO-OP KT training.

The long-term objective of CO-OP KT is to optimize functional outcomes for individuals with stroke and cognitive impairments. Three specific research questions have been posed, one of which is the focus of this registration. That sub study relates to patient outcomes following the CO-OP KT training initiative and it will be addressed using a non-randomized design with historical controls. Patient participants who enroll in the project prior to implementing the CO-OP KT training will belong to the historical control group. Patient participants who enroll in the project after the CO-OP KT training will belong to the CO-OP KT Exposure group.


Condition or disease Intervention/treatment
Stroke Behavioral: CO-OP KT Exposure

Detailed Description:

The investigative team will implement and evaluate a multi-faceted, supported, integrated knowledge translation initiative called CO-OP KT.

The long-term objective of CO-OP KT is to optimize functional outcomes for individuals with stroke and cognitive impairments. Three specific research questions are posed, one of which is the focus of this registration:

1. Is CO-OP KT associated with changes in activity, participation, and self-efficacy to perform daily activities in patients with cognitive impairment following stroke at discharge from inpatient rehabilitation and at 1, 3, and 6-month follow-ups? The research question, which relates to patient outcomes, will be addressed using a non-randomized design with historical controls.

Recruitment:

Five inpatient stroke rehabilitation units or combined stroke/neurology units within the Toronto Stroke Networks have agreed to participate. It is estimated that the 5 units together will have approximately 80 admissions per month. Patients admitted to the inpatient stroke unit who have at least some cognitive impairment will be recruited. Cognitive impairment will be determined using the Montreal Cognitive Assessment (MoCA). Patients with scores lower than 26 will be included. Based on data from a previously published study, a sample size of 13 per group will have 80% power to detect a between-group difference of 9 points on the FIM™, standard deviation of 8. Allowing for 30% attrition from all sources, the investigators will recruit 17 participants per group, 34 in total. Based on past experience, the investigators expect a consent rate of 1 participant per site per month. Thus, recruitment is highly feasible, and will likely be completed in 4 months for each group.

Data Analysis:

Descriptive statistics will be compiled for all quantitative data collected. Between- and within-group differences on the outcome measures will be examined using repeated measures ANOVA for the non-randomized trial of individual patients with historical controls.


Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment: An Evidence-based, Multi-faceted, Knowledge Translation Approach
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : August 31, 2018

Group/Cohort Intervention/treatment
Historical Control
Patient participants will be recruited from an inpatient rehabilitation stroke unit prior to introducing CO-OP KT training to the stroke team. Patient participants will receive Usual Care from their stroke team.
CO-OP KT Exposure group
Patient participants will be recruited from an inpatient rehabilitation stroke unit after the stroke team has been exposed to CO-OP KT training. Patient participants will receive Usual Care, augmented by CO-OP KT, from their stroke team.
Behavioral: CO-OP KT Exposure

Patient participants who receive therapy from clinicians who have received CO-OP KT training will belong to the CO-OP KT Exposure group. Patient participants will not receive treatment that is different from the treatment being offered to patients who do not enroll in the study.

The CO-OP KT intervention is directed at the inpatient rehabilitation team. They will be trained in Cognitive Orientation to daily Occupational Performance (CO-OP) and will also receive multi-faceted knowledge translation (KT) support.





Primary Outcome Measures :
  1. Change in Functional Independence Measure [FIM(TM)] score [ Time Frame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge. ]
    A system of disability measurement that rates the level of a patient's disability on a 7 point scale and indicates how much assistance is required for each. Consists of 18 items, 7 points each, 13 of which form the motor sub scale and 5 of which form the cognitive sub scale.


Secondary Outcome Measures :
  1. Change in Canadian Occupational Performance Measure (COPM) score [ Time Frame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge. ]
    The Canadian Occupational Performance Measure (COPM) is a standardized instrument for eliciting performance issues from the client perspective, and for capturing perceived changes in performance over time. A change of 2 points or more on the COPM is considered clinically significant.

  2. Change in Self-Efficacy Gauge (SEG) score [ Time Frame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge. ]
    The Self-Efficacy Gauge (SEG) was designed to measure an individual's self-efficacy in his or her ability to perform daily occupations that span a range of self-care, productivity, and leisure activities. Participants are asked to rate their confidence in their ability to perform 28 items, each on a 10-point scale, with 1 representing "not confident at all" and 10 representing "completely confident".

  3. Change in Stroke Impact Scale (SIS) score [ Time Frame: A) Within 1 week of admission to inpatient rehabilitation, B) At least 72 hours before discharge from inpatient rehabilitation, C) 1 month post discharge, D) 3 months post discharge, and E) 6 months post discharge. ]
    The Stroke Impact Scale (SIS) is a 59-item questionnaire about the perceived impact of stroke on function and everyday life. The SIS evaluates eight domains. Each item is scored on a 5-point Likert scale related to the degree of difficulty the person with stroke is experiencing. The SIS is widely used in stroke intervention studies as an outcome measure and the psychometric properties of the instrument are well-defined.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to an inpatient rehabilitation unit with a primary diagnosis of stroke and have a cognitive impairment.
Criteria

Inclusion Criteria:

- Patients who score lower than 26 on the Montreal Cognitive Assessment (MoCA) Test (indicates some level of cognitive impairment)

Exclusion Criteria:

  • neurological diagnoses other than stroke
  • the presence of major psychiatric illness
  • capacity issues requiring the use of a substitute decision maker under Ontario's Substitute Decision Maker Act

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): NCT02597569


Locations
Canada, Ontario
Providence Healthcare
Toronto, Ontario, Canada, M1L 1W1
Sunnybrook Health Sciences Centre - St. John's Rehab
Toronto, Ontario, Canada, M2M 2G1
Bridgepoint Active Healthcare
Toronto, Ontario, Canada, M4M 2B5
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M5G 2A2
West Park Healthcare Centre
Toronto, Ontario, Canada, M6M 2J5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University of Toronto
University Health Network, Toronto
West Park Healthcare Centre
Sinai Health System
Providence HealthCare
Investigators
Principal Investigator: Sara E McEwen, PhD Sunnybrook Research Institute

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02597569     History of Changes
Other Study ID Numbers: 177-2015
PHE-141799 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sunnybrook Health Sciences Centre:
stroke
Cognitive Orientation to daily Occupational Performance
health services accessibility
cognitive impairment
rehabilitation
integrated knowledge translation
interrupted time series
The CO-OP Approach

Additional relevant MeSH terms:
Stroke
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders