Study Stopped
Low enrollment
Written Versus Verbal Education for Mild Traumatic Brain Injury
1 other identifier
interventional
12
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2014
CompletedFirst Posted
Study publicly available on registry
September 30, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedNovember 15, 2018
November 1, 2018
11 months
August 28, 2014
November 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Glasgow Outcome Scale-Extended (GOS-E)
3 Months
Patient Health Questionnaire-9 (PHQ-9)
3 Months
PTSD Checklist-Civilian version (PCL-C)
3 Months
Study Arms (2)
Written Education
ACTIVE COMPARATORVerbal Education
ACTIVE COMPARATORInterventions
Participants will receive written education materials about mild traumatic brain injury.
A structured in-person education module about mild traumatic brain injury.
Eligibility Criteria
You may qualify if:
- Confirmation of a likely concussion without hospital admission
- Participants live locally with a fixed address
- Participants experience at least one new symptom
You may not qualify if:
- Participants who cannot understand/read English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lions Gate Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noah Silverberg, PhD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 28, 2014
First Posted
September 30, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
November 15, 2018
Record last verified: 2018-11