- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00359593
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
- Phase 3
Kontakte und Standorte
Studienorte
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 2A2
- Rekrutierung
- Toronto Rehabilitation Institute
-
Kontakt:
- Amanda Hurdowar, MSc
- Telefonnummer: 7859 416-597-3422
- E-Mail: Hurdowar.Amanda@TorontoRehab.on.ca
-
Hauptermittler:
- Mark T Bayley, MD
-
-
Quebec
-
Montreal, Quebec, Kanada, H3G 1Y5
- Noch keine Rekrutierung
- McGill University
-
Kontakt:
- Sharon Wood-Dauphinee, PhD
- Telefonnummer: (514) 398-5326
- E-Mail: sharon.wood.dauphinee@mcgill.ca
-
Hauptermittler:
- Sharon Wood-Dauphinee, PhD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Rehabilitation Hospitals/Research Sites:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inadequate staffing to administer the outcome measures consistently
Patients:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
|
Arm function as measured by the Box and Block test
|
|
Walking speed as measured by the 6 minutes walk test
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
|
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)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Mark T Bayley, MD, Toronto Rehabilitation Institute
- Hauptermittler: Sharon Wood-Dauphinee, PhD, McGill University
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CSNscore
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .