Written Versus Verbal Education for Mild Traumatic Brain Injury

Mild Traumatic Brain Injury Clinical Trial

Official title:

Written Versus Verbal Education for Mild Traumatic Brain Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02252315
• Other study ID #: H13-01647
• Status: Terminated
• Phase: N/A
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Confirmation of a likely concussion without hospital admission

• Participants live locally with a fixed address

• Participants experience at least one new symptom

Exclusion Criteria:

• Participants who cannot understand/read English

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Educational Brochure
Participants will receive written education materials about mild traumatic brain injury.
• Verbal education module
A structured in-person education module about mild traumatic brain injury.

Locations

Country	Name	City	State
Canada	Lions Gate Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Postconcussional Syndrome	The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as "mild" or greater on the Rivermead Postconcussion Symptom Questionnaire.	3 Months
Secondary	Glasgow Outcome Scale-Extended (GOS-E)	Structured interview to assess disability level.	3 Months
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Depressive symptoms questionnaire.	3 Months
Secondary	PTSD Checklist-Civilian version (PCL-C)	Post-traumatic stress symptoms questionnaire.	3 Months