<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02252315</url>
  </required_header>
  <id_info>
    <org_study_id>H13-01647</org_study_id>
    <nct_id>NCT02252315</nct_id>
  </id_info>
  <brief_title>Written Versus Verbal Education for Mild Traumatic Brain Injury</brief_title>
  <official_title>Written Versus Verbal Education for Mild Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <brief_summary>
    <textblock>
      Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or&#xD;
      alteration in mental status induced by an external mechanical force to the head. Education&#xD;
      about symptoms and reassurance of a prompt recovery usually results in full recovery.&#xD;
      However, a subgroup appears to have persistent symptoms and disability. This study will&#xD;
      recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable&#xD;
      patient characteristics that can delay or prevent full recovery. A secondary aim is to&#xD;
      determine if providing education in writing or in-person makes a difference.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of Postconcussional Syndrome</measure>
    <time_frame>3 Months</time_frame>
    <description>The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as &quot;mild&quot; or greater on the Rivermead Postconcussion Symptom Questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glasgow Outcome Scale-Extended (GOS-E)</measure>
    <time_frame>3 Months</time_frame>
    <description>Structured interview to assess disability level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>3 Months</time_frame>
    <description>Depressive symptoms questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist-Civilian version (PCL-C)</measure>
    <time_frame>3 Months</time_frame>
    <description>Post-traumatic stress symptoms questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Written Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Verbal Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Brochure</intervention_name>
    <description>Participants will receive written education materials about mild traumatic brain injury.</description>
    <arm_group_label>Written Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Verbal education module</intervention_name>
    <description>A structured in-person education module about mild traumatic brain injury.</description>
    <arm_group_label>Verbal Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmation of a likely concussion without hospital admission&#xD;
&#xD;
          -  Participants live locally with a fixed address&#xD;
&#xD;
          -  Participants experience at least one new symptom&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who cannot understand/read English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noah Silverberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lions Gate Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>November 13, 2018</last_update_submitted>
  <last_update_submitted_qc>November 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Noah Silverberg</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02252315
org study id: H13-01647
nct id: NCT02252315
lead sponsor: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Presence of Postconcussional Syndrome
time frame: 3 Months
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.
measure: Glasgow Outcome Scale-Extended (GOS-E)
time frame: 3 Months
description: Structured interview to assess disability level.
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: 3 Months
description: Depressive symptoms questionnaire.
measure: PTSD Checklist-Civilian version (PCL-C)
time frame: 3 Months
description: Post-traumatic stress symptoms questionnaire.
arm group label: Written Education
arm group type: Active Comparator
arm group label: Verbal Education
arm group type: Active Comparator
intervention type: Other
intervention name: Educational Brochure
description: Participants will receive written education materials about mild traumatic brain injury.
arm group label: Written Education
intervention type: Other
intervention name: Verbal education module
description: A structured in-person education module about mild traumatic brain injury.
arm group label: Verbal Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Noah Silverberg, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Noah Silverberg
investigator title: Principal Investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries