Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?
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|ClinicalTrials.gov Identifier: NCT03391583|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Headache Disorders Post-Concussion Syndrome Mild Traumatic Brain Injury||Other: Education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Control Feasibility trial looking at educational intervention at multiple time points during a patient's recovery from mild traumatic brain injury. The control group will be followed at these time points as well and will continue on with the current standard of care.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Subjects will be randomized via block randomization. An outcome assessor will have sealed envelopes that will assign the patients to either the intervention group versus the current standard of care. There will be three intervention time points 0, 6 and 12 weeks from the patient's initial presentation at the St. Michael's head injury clinic.|
|Official Title:||Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?|
|Actual Study Start Date :||January 8, 2018|
|Estimated Primary Completion Date :||December 17, 2019|
|Estimated Study Completion Date :||December 17, 2019|
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
No Intervention: Standard of Care
Current standard of care provided in tertiary health care setting
- Survey response [ Time Frame: 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.
- Rivermead post concussion questionnaire scores (RPQ) [ Time Frame: 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.
- Access to health care [ Time Frame: 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
- Social and Societal Functioning [ Time Frame: 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.
- Perceived quality of life [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391583
|Contact: Cindy Hunt, PH, RN||Phone: 416-864-6060 ext email@example.com|
|Contact: Candice M Todd, MD||416-603-5800 ext firstname.lastname@example.org|
|St. Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B 1W8,|
|Contact: Cindy Hunt, PhD. 416-864-6060 ext 77081 HuntCi@smh.ca|
|Contact: Candice M. Todd, MD 6473262662 email@example.com|
|Principal Investigator:||Andrew Baker||St. Michael's Hospital, Toronto|