Mild Traumatic Brain InjuryNCT02252315
Written Versus Verbal Education for Mild Traumatic Brain Injury
A study testing Educational Brochure and Verbal education module in people with Mild Traumatic Brain Injury, run by University of British Columbia at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Educational Brochure and Verbal education module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of a likely concussion without hospital admission
- Participants live locally with a fixed address
- Participants experience at least one new symptom
Who cannot join
- Participants who cannot understand/read English
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Lions Gate Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
About this study
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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Educational Brochure, Verbal education module
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational BrochureOther
Participants will receive written education materials about mild traumatic brain injury.
Verbal education moduleOther
A structured in-person education module about mild traumatic brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Written Education | Active comparator | Not described Receives: Other: Educational Brochure |
| Verbal Education | Active comparator | Not described Receives: Other: Verbal education module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (3)
Glasgow Outcome Scale-Extended (GOS-E)
Structured interview to assess disability level.
Measured: 3 Months
Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms questionnaire.
Measured: 3 Months
PTSD Checklist-Civilian version (PCL-C)
Post-traumatic stress symptoms questionnaire.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionApr 2016
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noah Silverberg, University of British Columbia
- Investigators
- Noah Silverberg, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252315
- Sponsor's protocol ID
- H13-01647
- Status last verified
- Nov 2018
- First submitted
- 28 Aug 2014
- Last updated
- 15 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Versus Verbal Education for Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02252315
- Acronym / sponsor ID
- H13-01647
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Education | Active comparator | Other: Educational Brochure |
| Verbal Education | Active comparator | Other: Verbal education module |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmation of a likely concussion without hospital admission
- Participants live locally with a fixed address
- Participants experience at least one new symptom
Key exclusion criteria (1 listed)
- Participants who cannot understand/read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational BrochureParticipants will receive written education materials about mild traumatic brain injury. | Other | Written Education |
| Verbal education moduleA structured in-person education module about mild traumatic brain injury. | Other | Verbal Education |
Primary outcome
Presence of Postconcussional Syndrome
Time frame: 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.
3 secondary outcomes
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: 3 Months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 Months
PTSD Checklist-Civilian version (PCL-C)
Time frame: 3 Months
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Silverberg, PhD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Brochure and Verbal education module in people with Mild Traumatic Brain Injury, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Postconcussional Syndrome (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.