<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/NCT04492696</url>
  </required_header>
  <id_info>
    <org_study_id>40500</org_study_id>
    <nct_id>NCT04492696</nct_id>
  </id_info>
  <brief_title>Comparison of Concussion Education Programs</brief_title>
  <official_title>Comparison of Concussion Education Programs and Intent to Report Concussion in High School Football Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting&#xD;
      in prolonged recovery. Athletes' report of concussion symptoms is therefore an important&#xD;
      component of risk reduction. Numerous educational interventions to improve concussion&#xD;
      knowledge and reporting exist.&#xD;
&#xD;
      Objective: Evaluate the comparative efficacy of three concussion education programs in&#xD;
      improving concussion-reporting intention.&#xD;
&#xD;
      Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment&#xD;
      before, immediately after, and one-month after educational intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in concussion reporting intention among athletes</measure>
    <time_frame>1 month</time_frame>
    <description>All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.&#xD;
A composite measure created based on the inverse of athlete responses to five questions about their concussion-reporting intention (i.e., whether they would continue playing with a concussion during &quot;the beginning of the season,&quot; &quot;a practice,&quot; &quot;the middle of the season,&quot; &quot;during a championship game,&quot; and &quot;at the end of the season&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in concussion knowledge among athletes</measure>
    <time_frame>1 month</time_frame>
    <description>Athletes answered 23 True/False questions to assess their concussion knowledge modified from previously utilized concussion educational assessments (Rosenbaum et al., 2010). A composite measure of athlete concussion knowledge was created by summing athletes' correct responses and dividing by the number of questions asked.&#xD;
Rosenbaum AM, Arnett PA. The development of a survey to examine knowledge about and attitudes toward concussion in high-school students. J Clin Exp Neuropsychol. 2010;32(1):44-55. doi:10.1080/13803390902806535</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in concussion attitudes among athletes</measure>
    <time_frame>1 month</time_frame>
    <description>All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.&#xD;
A composite measure created based on athlete responses to six questions about their attitudes towards concussion reporting (i.e., the extent to which an athlete who reports a concussion would be &quot;better off in the long run,&quot; &quot;back on the field much faster,&quot; &quot;proud even if teammates call me weak,&quot; &quot;better off avoiding participation with signs and symptoms of a concussion,&quot; not &quot;better off hiding symptoms from a doctor to not stay out as long,&quot; and not &quot;better off toughing it out because concussions are just another injury&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in concussion perceived normative beliefs among athletes</measure>
    <time_frame>1 month</time_frame>
    <description>All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.&#xD;
A composite measure created based on athlete responses to two questions assessing perceived reporting norms (i.e., the extent to which the athlete worried &quot;my teammates would think less of me&quot; if he reported a concussion, or needed to &quot;hide my symptoms from my coach&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in concussion perceived behavioral control among athletes</measure>
    <time_frame>1 month</time_frame>
    <description>All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.&#xD;
A composite measure created based on athlete responses to six questions about their perceived ability and confidence with concussion reporting (i.e., confidence in my ability &quot;to report a concussion,&quot; &quot;to help my teammate report a concussion,&quot; &quot;to report symptoms of a concussion,&quot; &quot;to help my teammate report symptoms of a concussion,&quot; &quot;to report symptoms of a concussion, even if I don't think they're that bad,&quot; and &quot;to help my teammate report symptoms of a concussion, even if I don't think they're that bad&quot;).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Concussion, Brain</condition>
  <arm_group>
    <arm_group_label>Crashcourse</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CC uses an approach to providing concussion education informed by user-centered formative design research studies. The program features an interactive &quot;choose your own adventure&quot; approach to navigate the learner through the content, and is guided by near-peer Division I collegiate football athletes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CDC Video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CDC-Vi is an online learning module developed by the CDC and the National Federation of State High School Associations Learning Center. Learners progress through the curriculum sequentially completing each unit before proceeding to the next. The primary narrator of CDC-Vi is Dr. Mick Koester, Chair of the NFHS Sports Medicine Advisory Committee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CDC Written</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CDC-Wr consists of educational PDFs available for download from the CDC website, as part of the CDC's &quot;Heads Up&quot; brain injury awareness initiative. The PDFs used for the CDC-Wr condition were specific to high school athlete concussion education</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Education</description>
    <arm_group_label>CDC Video</arm_group_label>
    <arm_group_label>CDC Written</arm_group_label>
    <arm_group_label>Crashcourse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Athletes from three high school football teams in California.&#xD;
&#xD;
          -  In attendance for practice on both study dates&#xD;
&#xD;
          -  Provided signed assent and parental consent.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Did not complete more than 50% of the questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>American football players</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Shelley Goldman</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Via contact with study PI, and pending approval of IRB</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <!-- 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/NCT04492696
org study id: 40500
nct id: NCT04492696
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting
      in prolonged recovery. Athletes' report of concussion symptoms is therefore an important
      component of risk reduction. Numerous educational interventions to improve concussion
      knowledge and reporting exist.

      Objective: Evaluate the comparative efficacy of three concussion education programs in
      improving concussion-reporting intention.

      Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment
      before, immediately after, and one-month after educational intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Improvement in concussion reporting intention among athletes
time frame: 1 month
description: All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.
A composite measure created based on the inverse of athlete responses to five questions about their concussion-reporting intention (i.e., whether they would continue playing with a concussion during "the beginning of the season," "a practice," "the middle of the season," "during a championship game," and "at the end of the season").
measure: Improvement in concussion knowledge among athletes
time frame: 1 month
description: Athletes answered 23 True/False questions to assess their concussion knowledge modified from previously utilized concussion educational assessments (Rosenbaum et al., 2010). A composite measure of athlete concussion knowledge was created by summing athletes' correct responses and dividing by the number of questions asked.
Rosenbaum AM, Arnett PA. The development of a survey to examine knowledge about and attitudes toward concussion in high-school students. J Clin Exp Neuropsychol. 2010;32(1):44-55. doi:10.1080/13803390902806535
measure: Improvement in concussion attitudes among athletes
time frame: 1 month
description: All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.
A composite measure created based on athlete responses to six questions about their attitudes towards concussion reporting (i.e., the extent to which an athlete who reports a concussion would be "better off in the long run," "back on the field much faster," "proud even if teammates call me weak," "better off avoiding participation with signs and symptoms of a concussion," not "better off hiding symptoms from a doctor to not stay out as long," and not "better off toughing it out because concussions are just another injury").
measure: Improvement in concussion perceived normative beliefs among athletes
time frame: 1 month
description: All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.
A composite measure created based on athlete responses to two questions assessing perceived reporting norms (i.e., the extent to which the athlete worried "my teammates would think less of me" if he reported a concussion, or needed to "hide my symptoms from my coach").
measure: Improvement in concussion perceived behavioral control among athletes
time frame: 1 month
description: All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10.
A composite measure created based on athlete responses to six questions about their perceived ability and confidence with concussion reporting (i.e., confidence in my ability "to report a concussion," "to help my teammate report a concussion," "to report symptoms of a concussion," "to help my teammate report symptoms of a concussion," "to report symptoms of a concussion, even if I don't think they're that bad," and "to help my teammate report symptoms of a concussion, even if I don't think they're that bad").
arm group label: Crashcourse
arm group type: Active Comparator
description: CC uses an approach to providing concussion education informed by user-centered formative design research studies. The program features an interactive "choose your own adventure" approach to navigate the learner through the content, and is guided by near-peer Division I collegiate football athletes
arm group label: CDC Video
arm group type: Active Comparator
description: CDC-Vi is an online learning module developed by the CDC and the National Federation of State High School Associations Learning Center. Learners progress through the curriculum sequentially completing each unit before proceeding to the next. The primary narrator of CDC-Vi is Dr. Mick Koester, Chair of the NFHS Sports Medicine Advisory Committee
arm group label: CDC Written
arm group type: Active Comparator
description: CDC-Wr consists of educational PDFs available for download from the CDC website, as part of the CDC's "Heads Up" brain injury awareness initiative. The PDFs used for the CDC-Wr condition were specific to high school athlete concussion education
intervention type: Other
intervention name: Education
description: Education
arm group label: CDC Video
arm group label: CDC Written
arm group label: Crashcourse
criteria: 
gender: Male
gender based: Yes
gender description: American football players
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Shelley Goldman
investigator title: Principle Investigator
mesh term: Brain Concussion
sharing ipd: Yes
ipd description: Via contact with study PI, and pending approval of IRB
ipd info type: Study Protocol