StrokePhase 2/3NCT00359593
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
A Phase 2/3 study testing Knowledge translation intervention package in people with Stroke, run by Toronto Rehabilitation Institute at 2 sites in Canada.
Trial summary
The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Knowledge translation intervention package
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2006to Apr 2008
- Phase
- Phase 2/3
- 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
Who may be able to join
- hospital with designated rehabilitation beds;
- regularly treats stroke patients;
- has access to at least one physical (PT) and one occupational (OT) therapist on the health professional team
- medically stable;
- stroke with residual disability;
- requires complex rehabilitation interventions from at least 3 health care professionals, one of them being an OT or a PT;
- admitted to rehabilitation centre within 90 days of stroke onset;
- and age >18 years
Who cannot join
- Inadequate staffing to administer the outcome measures consistently
- Patients:
- having a medical condition that is expected to result in death within 6 months;
- presence of a serious chronic disabling condition that impacts on either the rehabilitation process or rehabilitation outcomes such as severe arthritis, dementia, Parkinson's disease;
- active suicidal ideation or symptoms of psychosis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
McGill University
Montreal, Quebec, H3G 1Y5
Sharon Wood-Dauphinee, PhD, (514) 398-5326, sharon.wood.dauphinee@mcgill.ca
Sharon Wood-Dauphinee, PhD
- Recruiting
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
Amanda Hurdowar, MSc, 416-597-3422 ext. 7859, Hurdowar.Amanda@TorontoRehab.on.ca
Mark T Bayley, MD
About this study
Official title: Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.
Read the detailed description
Stroke is a leading cause of disability in Canada and frequently causes hemiparesis (upper limb and lower limb weakness on one side of the body). Approximately one third of stroke survivors require physical rehabilitation to improve their motor and functional recovery (1). Although many strategies have been shown to be effective in promoting recovery after stroke, the uptake of evidence-based practice by rehabilitation professionals across Canada is variable. The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.
This project is a cluster randomized implementation trial for upper and lower limb interventions. Rehabilitation centres across Canada will be randomized to receive either an outcome-oriented implementation strategy (OOI) to facilitate implementation of the EIPRs or a process-oriented implementation strategy (POI). At the onset, rehabilitation professionals practicing in all centres will receive education in using best practice outcome measures related to stroke rehabilitation. All centres will be assessed for baseline adherence to the EIPRs. Centres in the OOI will receive "usual care" (i.e. passive dissemination of the written protocols and information about outcome measures). Centres in the POI arm will receive a combination of strategies to facilitate EIPR uptake (i.e., use of a local facilitator, practice audits with feedback, reminder systems and educational sessions). Following exposure to the EIPRs, all centres will document adherence to the EIPRs, and patient outcomes as assessed by the measures. An analysis of the costs associated with rehabilitation interventions and the incremental expense of a POI strategy will be undertaken. These data will be used to compare the OOI and POI centres with respect to the level of uptake and implementation of EIPRs and related expenses.
- Conditions
- Stroke
- Being tested
- Knowledge translation intervention package
- Keywords
- Stroke, Rehabilitation, Knowledge translation, Evidence based practice, Outcomes
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge translation intervention packageBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm function as measured by the Box and Block test
Walking speed as measured by the 6 minutes walk test
Secondary outcomes (4)
Arm function as measured by the Chedoke Arm and Hand Activity Inventory (CAHAI- 9)
Impairment as measured by the Chedoke-McMaster Stroke Assessment Scale (CMSA)
Independence of daily living as measured by the 3. Functional Independence Measure (FIM)
Economic outcomes measured by the Quality Adjusted Life Years (QALY)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startSep 2006
- Study completionApr 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Investigators
- Mark T Bayley, MD, Principal investigator, Toronto Rehabilitation InstituteSharon Wood-Dauphinee, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359593
- Sponsor's protocol ID
- CSNscore
- Status last verified
- Jul 2006
- First submitted
- 31 Jul 2006
- Last updated
- 20 Mar 2008
- Results posted
- No
Publications
Salbach NM, Wood-Dauphinee S, Desrosiers J, Eng JJ, Graham ID, Jaglal SB, Korner-Bitensky N, MacKay-Lyons M, Mayo NE, Richards CL, Teasell RW, Zwarenstein M, Bayley MT; Stroke Canada Optimization of Rehabilitation By Evidence - Implementation Trial (SCORE-IT) Team. Facilitated interprofessional implementation of a physical rehabilitation guideline for stroke in inpatient settings: process evaluation of a cluster randomized trial. Implement Sci. 2017 Aug 1;12(1):100. doi: 10.1186/s13012-017-0631-7.
PubMed 28764752
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
- ClinicalTrials.gov ID
- NCT00359593
- Acronym / sponsor ID
- CSNscore
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Knowledge translation, Evidence based practice, Outcomes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- Sep 2006
- Study completion
- Apr 2008 (estimated)
- First posted
- 2 Aug 2006 (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.
The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.
Detailed description
Stroke is a leading cause of disability in Canada and frequently causes hemiparesis (upper limb and lower limb weakness on one side of the body). Approximately one third of stroke survivors require physical rehabilitation to improve their motor and functional recovery (1). Although many strategies have been shown to be effective in promoting recovery after stroke, the uptake of evidence-based practice by rehabilitation professionals across Canada is variable. The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.
This project is a cluster randomized implementation trial for upper and lower limb interventions. Rehabilitation centres across Canada will be randomized to receive either an outcome-oriented implementation strategy (OOI) to facilitate implementation of the EIPRs or a process-oriented implementation strategy (POI). At the onset, rehabilitation professionals practicing in all centres will receive education in using best practice outcome measures related to stroke rehabilitation. All centres will be assessed for baseline adherence to the EIPRs. Centres in the OOI will receive "usual care" (i.e. passive dissemination of the written protocols and information about outcome measures). Centres in the POI arm will receive a combination of strategies to facilitate EIPR uptake (i.e., use of a local facilitator, practice audits with feedback, reminder systems and educational sessions). Following exposure to the EIPRs, all centres will document adherence to the EIPRs, and patient outcomes as assessed by the measures. An analysis of the costs associated with rehabilitation interventions and the incremental expense of a POI strategy will be undertaken. These data will be used to compare the OOI and POI centres with respect to the level of uptake and implementation of EIPRs and related expenses.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- hospital with designated rehabilitation beds;
- regularly treats stroke patients;
- has access to at least one physical (PT) and one occupational (OT) therapist on the health professional team
- medically stable;
- stroke with residual disability;
Key exclusion criteria (5 listed)
- Inadequate staffing to administer the outcome measures consistently
- having a medical condition that is expected to result in death within 6 months;
- presence of a serious chronic disabling condition that impacts on either the rehabilitation process or rehabilitation outcomes such as severe arthritis, dementia, Parkinson's disease;
- active suicidal ideation or symptoms of psychosis
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 |
|---|---|---|
| Knowledge translation intervention package | Behavioural | – |
Primary outcome
Arm function as measured by the Box and Block test
Walking speed as measured by the 6 minutes walk test
4 secondary outcomes
Arm function as measured by the Chedoke Arm and Hand Activity Inventory (CAHAI- 9)
Impairment as measured by the Chedoke-McMaster Stroke Assessment Scale (CMSA)
Independence of daily living as measured by the 3. Functional Independence Measure (FIM)
Economic outcomes measured by the Quality Adjusted Life Years (QALY)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2008.
- Derived from this study: PubMed 28764752Salbach NM, Wood-Dauphinee S, Desrosiers J, Eng JJ, Graham ID, Jaglal SB, Korner-Bitensky N, MacKay-Lyons M, Mayo NE, Richards CL, Teasell RW, Zwarenstein M, Bayley MT; Stroke Canada Optimization of Rehabilitation By Evidence - Implementation Trial (SCORE-IT) Team. Facilitated interprofessional implementation of a physical rehabilitation guideline for stroke in inpatient settings: process evaluation of a cluster randomized trial. Implement Sci. 2017 Aug 1;12(1):100. doi: 10.1186/s13012-017-0631-7.
- Canadian Stroke NetworkLink provided by the sponsor.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Mark T Bayley, MD principal investigator
Toronto Rehabilitation Institute
Sharon Wood-Dauphinee, PhD principal investigator
McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Knowledge translation intervention package in people with Stroke, run by Toronto Rehabilitation Institute at 2 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda G Hurdowar, MSc (416-597-3422 ext. 7859, Hurdowar.Amanda@TorontoRehab.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm function as measured by the Box and Block test. The study lists 2 primary outcomes in all. 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 NCT00359593, which also lists 1 linked publication.
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 Mar 2008.