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

U

Unity Health Toronto

Status

Unknown

Conditions

Headache Disorders
Post-Concussion Syndrome
Mild Traumatic Brain Injury

Treatments

Other: Education

Study type

Interventional

Funder types

Other

Identifiers

NCT03391583
Grant 17-0098-GAP

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Standard of Care plus Education
Experimental group
Description:
Educational material will be provided at three time points along with the current standard of care provided in tertiary health care setting
Treatment:
Other: Education
Standard of Care
No Intervention group
Description:
Current standard of care provided in tertiary health care setting

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Candice M Todd, MD; Cindy Hunt, PH, RN

Data sourced from clinicaltrials.gov

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