- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00359593
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial SCORE-IT)
Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M5G 2A2
- Recrutamento
- Toronto Rehabilitation Institute
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Contato:
- Amanda Hurdowar, MSc
- Número de telefone: 7859 416-597-3422
- E-mail: 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
- Ainda não está recrutando
- McGill University
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Contato:
- Sharon Wood-Dauphinee, PhD
- Número de telefone: (514) 398-5326
- E-mail: sharon.wood.dauphinee@mcgill.ca
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Investigador principal:
- Sharon Wood-Dauphinee, PhD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
O que o estudo está medindo?
Medidas de resultados primários
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 resultados secundários
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
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CSNscore
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