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NCT Number: NCT02597569

Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment

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Patients with cognitive impairment who are admitted to inpatient stroke rehabilitation often receive services based on outdated impairment-reduction models, rather than recommended function-based approaches.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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bridgepoint Active Healthcare, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO-OP KT Exposure

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Providence Healthcare
  • Sinai Health System
  • University Health Network, Toronto
  • University of Toronto
  • West Park Healthcare Centre

Registry information

Official study title

Building Capacity in the System to Support Persons With Stroke and Cognitive Impairment: An Evidence-based, Multi-faceted, Knowledge Translation Approach

Acronym: CO-OP_KT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2015
Registry last updated
Sep 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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