An interventional study of Education in Headache Disorders, Post-Concussion Syndrome and Mild Traumatic Brain Injury, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
The study will ask the question as to whether or not it is possible to deliver education material to patients with a mild traumatic brain injury in a consistent matter. The question will be asked as to whether an educational intervention decreases symptom reporting specifically looking at headache symptoms. Half of the patients will receive the current standard of care in the tertiary clinic they have been referred to while the other half will also receive the current standard of care with the addition of targeted headache educational material at various time points.
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.
145 studies on the registry are indexed under Headache Disorders; 37 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 98 interventional studies indexed under Headache Disorders.
Browse Headache Disorders studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Educational material will be provided at three time points along with the current standard of care provided in tertiary health care setting
Other: Education
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
Survey response
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.
Time frame: 12 weeks
Rivermead post concussion questionnaire scores (RPQ)
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.
Time frame: 12 weeks
Access to health care
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
Time frame: 12 weeks
Social and Societal Functioning
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.
Time frame: 12 weeks
Perceived quality of life
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.
Time frame: 12 weeks
Plan to share: Yes — Patient study data will be de-identified or coded. A master linking log with identifiers will be kept and stored separately from the data. Data for all primary and secondary outcomes will be available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The data will be available 6 months post study completion.
Access criteria: Data access requests will be independently reviewed by the St. Michael's Steering Committee. Requesters will sign a Data Access Agreement.
Started Jan 2018 (actual). Primary completion is estimated for Dec 2019, 23 months after the start.
Of 41 non-industry interventional studies with no phase under Headache Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 42. This study's planned 23 months is above that.
Counting every sponsor, half of 43 studies reached it within 20 months; a quarter within 7 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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