Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT03391583

Conditions

Headache Disorders

Post-Concussion Syndrome

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Education

Study Details

Brief 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.

Conditions

Headache Disorders

Post-Concussion Syndrome

Mild Traumatic Brain Injury

Study ID

NCT03391583

Start date

Jan 8, 2018

Status verified date

Apr, 2019

Completion date

Dec 17, 2019

Anticipated

Primary completion date

Dec 17, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

no intervention: Standard of Care

Current standard of care provided in tertiary health care setting

Interventions

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

Primary outcome measure

  • Survey response [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Cindy Hunt, PH, RN

Phone: 416-864-6060huntci@smh.ca

Candice M Todd, MD

416-603-5800candice.todd@mail.utoronto.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8,

Contacts

Cindy Hunt, PhD.

416-864-6060HuntCi@smh.ca

Candice M. Todd, MD

6473262662candice.todd@mail.utoronto.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 18, 2019

Last verified

Apr, 2019

Keywords

  • Education
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-04-18.