Comparison of Concussion Education Programs

July 27, 2020 updated by: Shelley Goldman, Stanford University

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Via contact with study PI, and pending approval of IRB

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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