- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04492696
Comparison of Concussion Education Programs
Comparison of Concussion Education Programs and Intent to Report Concussion in High School Football Athletes
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion:
- Athletes from three high school football teams in California.
- In attendance for practice on both study dates
- Provided signed assent and parental consent.
Exclusion:
- Did not complete more than 50% of the questionnaire.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Crashcourse
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
|
Education
|
Active Comparator: CDC Video
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
|
Education
|
Active Comparator: CDC Written
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
|
Education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in concussion reporting intention among athletes
Time Frame: 1 month
|
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"). |
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in concussion knowledge among athletes
Time Frame: 1 month
|
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 |
1 month
|
Improvement in concussion attitudes among athletes
Time Frame: 1 month
|
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"). |
1 month
|
Improvement in concussion perceived normative beliefs among athletes
Time Frame: 1 month
|
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"). |
1 month
|
Improvement in concussion perceived behavioral control among athletes
Time Frame: 1 month
|
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"). |
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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