Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?

Mild Traumatic Brain Injury Clinical Trial

Official title:

Can Targeted Education Impact the Current Standard of Care in Patients With Mild Traumatic Brain Injury?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391583
• Other study ID #: Grant 17-0098-GAP
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 17, 2019

Study information

• Verified date: April 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Cindy Hunt, PH, RN
• Phone: Phone: 416-864-6060
• Email: huntci[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Headache
• Headache Disorders
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome
• Wounds and Injuries

Intervention

Other:
• Education
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

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Azulay J, Smart CM, Mott T, Cicerone KD. A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):323-31. doi: 10.1097/HTR.0b013e318250ebda. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks

External Links

•   Data Capture and Management at St. Michaels
•   Head Injury Clinic Website