- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00359593
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5G 2A2
- Reclutamento
- Toronto Rehabilitation Institute
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Contatto:
- Amanda Hurdowar, MSc
- Numero di telefono: 7859 416-597-3422
- Email: Hurdowar.Amanda@TorontoRehab.on.ca
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Investigatore principale:
- Mark T Bayley, MD
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Quebec
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Montreal, Quebec, Canada, H3G 1Y5
- Non ancora reclutamento
- McGill University
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Contatto:
- Sharon Wood-Dauphinee, PhD
- Numero di telefono: (514) 398-5326
- Email: sharon.wood.dauphinee@mcgill.ca
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Investigatore principale:
- Sharon Wood-Dauphinee, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Arm function as measured by the Box and Block test
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Walking speed as measured by the 6 minutes walk test
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Misure di risultato secondarie
Misura del risultato |
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Arm function as measured by the Chedoke Arm and Hand Activity Inventory (CAHAI- 9)
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Impairment as measured by the Chedoke-McMaster Stroke Assessment Scale (CMSA)
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Independence of daily living as measured by the 3. Functional Independence Measure (FIM)
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Economic outcomes measured by the Quality Adjusted Life Years (QALY)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Mark T Bayley, MD, Toronto Rehabilitation Institute
- Investigatore principale: Sharon Wood-Dauphinee, PhD, McGill University
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CSNscore
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .