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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03391583
Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Post-traumatic headache is a common symptom endorsed in individuals who have suffered from mild traumatic brain injury. Headaches are often debilitating and can significantly impact a patient's ability to function and interact in society(Azulay et.al 2013).
The provision of education to patients and primary care physicians is important. There is often not enough time during clinic appointments to ensure that patients understand the pathophysiology, treatment and red-flags of their post concussive symptoms. The question is asked as to whether educational material can be delivered in a consistent and comprehensible manner.
The study will look at whether or not targeted headache education material presented to patients at multiple time points outside of the current standard of care is feasible and if there is any impact on symptom severity scores utilizing standardized surveys such as the Rivermead Post Concussion Questionnaire. A patient's frequency and type of social interactions during their recovery along with their perceived quality of life will be measured using the Participation Assessment with Recombined Tools-Objective (PART-O tool) and the Quality of Life after Brain Injury (Quolibri) tools respectively will be analyzed. By providing the basics of when to seek medical attention, the hope is be able to track what type and how frequently patients access medical treatment outside of the tertiary care clinic setting.
The investigators would like to see whether this education model is feasible and can be used as a consistent message sent to patients as well as other health care professionals.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M5B 1W8,
- Recrutamento
- St. Michael's Hospital
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Contato:
- Cindy Hunt, PhD.
- Número de telefone: 77081 416-864-6060
- E-mail: HuntCi@smh.ca
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Contato:
- Candice M. Todd, MD
- Número de telefone: 6473262662
- E-mail: candice.todd@mail.utoronto.ca
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients must be diagnosed with a chronic ( between 2 and 4 months post injury) mTBI based on CDC criteria. They must have the ability to give consent, speak English with awareness that they will need to be contacted at various time points, and must have access to email. There will be inclusion of patients who score 3 or more on the RPQ during their initial assessment in the St. Michael's Head Injury Clinic. They must be medically stable.
Exclusion Criteria:
- Patients will be excluded from the study if they have a documented history of moderate to severe traumatic brain injury. If they have a prior history of other neurological (i.e. Epilepsy, MS, Alzheimer's Disease, primary headache disorder), psychiatric (i.e. Psychotic disorder or other history of a mental health disorder) or substance abuse disorders. Subjects will be excluded if they have no fixed address or are incarcerated, as that would hinder follow up.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Standard of Care plus Education
Educational material will be provided at three time points along with the current standard of care provided in tertiary health care setting
|
Participants in the education arm of the study will be provided with three PowerPoint presentations.
Material for these slides has been adapted from material developed by the Ontario Neurotrauma Foundation.
Topics to be addressed will surround post-traumatic headache and will include information regarding common symptoms, timeline for improvement, red- flags and when to seek medical attention
|
Sem intervenção: Standard of Care
Current standard of care provided in tertiary health care setting
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Survey response
Prazo: 12 weeks
|
How many people randomized to the study will complete the study.
This will be a raw number and calculated by counting how many people complete the administered surveys at the end of the trial.
|
12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Rivermead post concussion questionnaire scores (RPQ)
Prazo: 12 weeks
|
The Rivermead post concussion questionnaire (RPQ) asks 16 questions about patient's headache symptoms after head injury and are given a scale from 0-4 in order to rate symptoms from none to maximum severity (0 = Not experienced at all, 1 = No more of a problem, 2 = A mild problem, 3 = A moderate problem and 4 = a severe problem). The first three questions( RPQ-3) focuses on the most frequently endorsed headache symptoms. This study aims to reduce a patients overall score at the end of the study by 3 with the max possible score being 12 ( maximum score of 4 times 3 questions). Only those initially scoring 9 or more out of the 12 will be asked to participate in the study. The last thirteen questions (RPQ-13) focuses on other frequently endorsed symptoms of headache. For these questions, the target is to decrease a patient's total score by 10 out of a possible maximum score of 52 (maximum score of 4 times 13 questions). Both the RPQ-3 and 13 will be compared to the standard of care. |
12 weeks
|
Access to health care
Prazo: 12 weeks
|
What type of health care services do participants in this study access.
Both the educational group and the standard of care patients will be asked to document this on administered surveys
|
12 weeks
|
Social and Societal Functioning
Prazo: 12 weeks
|
Can an educational intervention regarding headache management and lifestyle strategies improve social/societal functioning.
This will be assessed with the Participation Assessment with Recombined Tools (PART-O tool).
A 5-point decrease in total score out of 17 questions will be deemed significant.
|
12 weeks
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Perceived quality of life
Prazo: 12 weeks
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Does education and reassurance alter a patient's perceived quality of life after a mild-traumatic brain injury. This will be analyzed by using the QOLIBRI (Quality of Life after Brain Injury). The investigators hope to capture whether or not patients believe they play an active role in their health and whether or not they feel empowered to alter their health status. The point is to capture what barriers there are to a patient's recovery in regard to what negative feelings and limits they perceive. |
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew Baker, Unity Health Toronto
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Dor
- Manifestações Neurológicas
- Trauma Craniocerebral
- Trauma, Sistema Nervoso
- Traumatismos na Cabeça, Fechado
- Ferimentos Não Penetrantes
- Lesões cerebrais
- Ferimentos e Lesões
- Lesões Cerebrais Traumáticas
- Dor de cabeça
- Síndrome pós-concussão
- Distúrbios de dor de cabeça
- Concussão cerebral
Outros números de identificação do estudo
- Grant 17-0098-GAP
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Dados/documentos do estudo
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Conjunto de dados de participantes individuais
Comentários informativos:
The Applied Health Research Centre (AHRC), an academic research organization based at St Michael's Hospital, will use software called REDCap to create the web-based electronic CRF (eCRF).
Authorized personnel receive a username and password which is unique, and database access is controlled by the DCC in collaboration with the Principal Investigator.
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