StrokeCO-OP_KTNCT02597569
Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment
An observational study of Stroke, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.
Trial 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Patients with cognitive impairment who are admitted to inpatient stroke rehabilitation often receive services based on outdated impairment-reduction models, rather than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- CO-OP KT Exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Jan 2016to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to an inpatient rehabilitation unit with a primary diagnosis of stroke and have a cognitive impairment.
Who may be able to join
- Patients who score lower than 26 on the Montreal Cognitive Assessment (MoCA) Test (indicates some level of cognitive impairment)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Providence Healthcare
Toronto, Ontario, M1L 1W1
Sunnybrook Health Sciences Centre - St. John's Rehab
Toronto, Ontario, M2M 2G1
Bridgepoint Active Healthcare
Toronto, Ontario, M4M 2B5
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
West Park Healthcare Centre
Toronto, Ontario, M6M 2J5
About this study
Official title: Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment: An Evidence-based, Multi-faceted, Knowledge Translation Approach
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.
Read the 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:
- 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.
- Conditions
- Stroke
- Being tested
- CO-OP KT Exposure
- Keywords
- stroke, Cognitive Orientation to daily Occupational Performance, health services accessibility, cognitive impairment, rehabilitation, integrated knowledge translation, interrupted time series, The CO-OP Approach
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-OP KT ExposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CO-OP KT Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Independence Measure [FIM(TM)] score
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.
Measured: 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.
Secondary outcomes (3)
Change in Canadian Occupational Performance Measure (COPM) score
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.
Measured: 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.
Change in Self-Efficacy Gauge (SEG) score
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".
Measured: 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.
Change in Stroke Impact Scale (SIS) score
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion31 Mar 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University Health Network, Toronto, West Park Healthcare Centre, Sinai Health System, Providence Healthcare
- Responsible party
- Sponsor
- Investigators
- Sara E McEwen, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597569
- Sponsor's protocol ID
- 177-2015
- Other IDs
- PHE-141799
- Acronym
- CO-OP_KT
- Status last verified
- Sep 2018
- First submitted
- 30 Oct 2015
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rios J, Linkewich E, Allen KA, Egan M, Dawson DR, Godleski M, Hunt A, Jutzi K, Quant S, McEwen SE. Lessons learned and functional outcomes following multifaceted team training in a cognitive strategy-based approach to stroke rehabilitation. JBI Evid Implement. 2022 Feb 14;20(1):33-43. doi: 10.1097/XEB.0000000000000308.
PubMed 35165236Linkewich E, Avery L, Rios J, McEwen SE. Minimal Clinically Important Differences in Functional Independence After a Knowledge Translation Intervention in Stroke Rehabilitation. Arch Phys Med Rehabil. 2020 Apr;101(4):587-591. doi: 10.1016/j.apmr.2019.10.185. Epub 2019 Nov 15.
PubMed 31738892
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment: An Evidence-based, Multi-faceted, Knowledge Translation Approach
- ClinicalTrials.gov ID
- NCT02597569
- Acronym / sponsor ID
- CO-OP_KT / 177-2015
- Conditions
- Stroke
- Keywords
- stroke, Cognitive Orientation to daily Occupational Performance, health services accessibility, cognitive impairment, rehabilitation, integrated knowledge translation, interrupted time series, The CO-OP Approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Toronto, University Health Network, Toronto, West Park Healthcare Centre, Sinai Health System, Providence Healthcare
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: CO-OP KT ExposurePatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to an inpatient rehabilitation unit with a primary diagnosis of stroke and have a cognitive impairment.
Key inclusion criteria (1 listed)
- Patients who score lower than 26 on the Montreal Cognitive Assessment (MoCA) Test (indicates some level of cognitive impairment)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-OP KT ExposurePatient 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. | Behavioural | CO-OP KT Exposure group |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Derived from this study: PubMed 35165236Rios J, Linkewich E, Allen KA, Egan M, Dawson DR, Godleski M, Hunt A, Jutzi K, Quant S, McEwen SE. Lessons learned and functional outcomes following multifaceted team training in a cognitive strategy-based approach to stroke rehabilitation. JBI Evid Implement. 2022 Feb 14;20(1):33-43. doi: 10.1097/XEB.0000000000000308.
- Derived from this study: PubMed 31738892Linkewich E, Avery L, Rios J, McEwen SE. Minimal Clinically Important Differences in Functional Independence After a Knowledge Translation Intervention in Stroke Rehabilitation. Arch Phys Med Rehabil. 2020 Apr;101(4):587-591. doi: 10.1016/j.apmr.2019.10.185. Epub 2019 Nov 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara E McEwen, PhD principal investigator
Sunnybrook Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597569, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.