Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Toronto, Ontario, Canadá, M5B 1W8,
- Reclutamiento
- St. Michael's Hospital
-
Contacto:
- Cindy Hunt, PhD.
- Número de teléfono: 77081 416-864-6060
- Correo electrónico: HuntCi@smh.ca
-
Contacto:
- Candice M. Todd, MD
- Número de teléfono: 6473262662
- Correo electrónico: candice.todd@mail.utoronto.ca
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
|
Sin intervención: Standard of Care
Current standard of care provided in tertiary health care setting
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Survey response
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rivermead post concussion questionnaire scores (RPQ)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Perceived quality of life
Periodo de tiempo: 12 weeks
|
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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Dolor
- Manifestaciones neurológicas
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Traumatismos craneales, Cerrado
- Heridas No Penetrantes
- Lesiones Cerebrales
- Heridas y Lesiones
- Lesiones Cerebrales Traumáticas
- Dolor de cabeza
- Síndrome posterior a la conmoción cerebral
- Trastornos de dolor de cabeza
- Contusión cerebral
Otros números de identificación del estudio
- Grant 17-0098-GAP
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Datos del estudio/Documentos
-
Conjunto de datos de participantes individuales
Comentarios de información:
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .