Written Versus Verbal Education for Mild Traumatic Brain Injury

Not Applicable

Terminated

• Conditions: Mild Traumatic Brain Injury
• Interventions: Other: Educational Brochure; Other: Verbal education module

• Registration Number: NCT02252315
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Study Start: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Confirmation of a likely concussion without hospital admission
• Participants live locally with a fixed address
• Participants experience at least one new symptom

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Exclusion Criteria

• Participants who cannot understand/read English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written Education	Educational Brochure	-
Verbal Education	Verbal education module	-

Primary Outcome Measures

Name	Time	Method
Presence of Postconcussional Syndrome	3 Months	The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as "mild" or greater on the Rivermead Postconcussion Symptom Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale-Extended (GOS-E)	3 Months	Structured interview to assess disability level.
Patient Health Questionnaire-9 (PHQ-9)	3 Months	Depressive symptoms questionnaire.
PTSD Checklist-Civilian version (PCL-C)	3 Months	Post-traumatic stress symptoms questionnaire.

Trial Locations

Locations (2)

Lions Gate Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada