Back to resultsWritten Versus Verbal Education for Mild Traumatic Brain Injury
Primary Purpose
Mild Traumatic Brain Injury
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational Brochure
Verbal education module
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury
Eligibility Criteria
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
Sites / Locations
- Lions Gate Hospital
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Written Education
Verbal Education
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Glasgow Outcome Scale-Extended (GOS-E)
Structured interview to assess disability level.
Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms questionnaire.
PTSD Checklist-Civilian version (PCL-C)
Post-traumatic stress symptoms questionnaire.
Full Information
NCT ID
NCT02252315
First Posted
August 28, 2014
Last Updated
November 13, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02252315
Brief Title
Written Versus Verbal Education for Mild Traumatic Brain Injury
Official Title
Written Versus Verbal Education for Mild Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Written Education
Arm Type
Active Comparator
Arm Title
Verbal Education
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Educational Brochure
Intervention Description
Participants will receive written education materials about mild traumatic brain injury.
Intervention Type
Other
Intervention Name(s)
Verbal education module
Intervention Description
A structured in-person education module about mild traumatic brain injury.
Primary Outcome Measure Information:
Title
Presence of Postconcussional Syndrome
Description
The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as "mild" or greater on the Rivermead Postconcussion Symptom Questionnaire.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Glasgow Outcome Scale-Extended (GOS-E)
Description
Structured interview to assess disability level.
Time Frame
3 Months
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
Depressive symptoms questionnaire.
Time Frame
3 Months
Title
PTSD Checklist-Civilian version (PCL-C)
Description
Post-traumatic stress symptoms questionnaire.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Silverberg, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Gate Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Written Versus Verbal Education for Mild Traumatic Brain Injury
We'll reach out to this number within 24 hrs