- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00359593
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amanda G Hurdowar, MSc
- Número de teléfono: 7859 416-597-3422
- Correo electrónico: Hurdowar.Amanda@TorontoRehab.on.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 2A2
- Reclutamiento
- Toronto Rehabilitation Institute
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Contacto:
- Amanda Hurdowar, MSc
- Número de teléfono: 7859 416-597-3422
- Correo electrónico: Hurdowar.Amanda@TorontoRehab.on.ca
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Investigador principal:
- Mark T Bayley, MD
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Quebec
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Montreal, Quebec, Canadá, H3G 1Y5
- Aún no reclutando
- McGill University
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Contacto:
- Sharon Wood-Dauphinee, PhD
- Número de teléfono: (514) 398-5326
- Correo electrónico: sharon.wood.dauphinee@mcgill.ca
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Investigador principal:
- Sharon Wood-Dauphinee, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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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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Medidas de resultado secundarias
Medida de resultado |
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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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark T Bayley, MD, Toronto Rehabilitation Institute
- Investigador principal: Sharon Wood-Dauphinee, PhD, McGill University
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSNscore
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