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Completed

NCT Number: NCT04122274

Comparing and Interactive Concussion Education Platform to Current Education Standards

Purpose: The purpose of this study is to evaluate the effectiveness of a theory- driven education platform to improve concussion-related norms and perceptions in an effort to improve student-athletes concussion-related decision-making.

Participants: 80 college-aged recreational athletes.

Procedures: The study is a single-blind (participants) randomized control trial where participants will complete a previously validated survey assessing concussion knowledge, perceived norms, attitudes, and behavioral intentions immediately pre- and post-receipt of their designated intervention. Participants will also complete the previously validated survey two-week post receipt of their designated intervention. The interventions include an interactive concussion education platform along with the NCAA (National Collegiate Athletic Association) concussion education sheet and the NCAA concussion education sheet alone (with a sham educational intervention similar in length to the concussion education platform).

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Key information

Conditions

Concussion, Brain Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

A convenience sample of participants will be recruited from the University of North Carolina at Chapel Hill student-body from November-January via campus emails, in-class recruitment, flyers/informational sheets, and word of mouth from fellow participants. During the beginning of recruitment, efforts were targeted towards males with participant numbers being carefully monitored. Recruitment will be targeted to recruit an even number of males and females. Interested participants will be contacted to confirm interest and those who remained interested will be scheduled to complete the study session. Participants will report to an on-campus athletic training facility or research laboratory or may report/complete study activities virtually.

Participants will then complete the written, informed consent process. The consent form indicated that they would be completing a sport-related educational intervention to not disclose the information they would receive and to keep participants blind to their intervention group assignment. Participants will not be explicitly told that it is a study evaluating concussion education, but rather an injury and nutrition study, to reduce bias. Once the consent form was signed, participants were assigned a unique identifier and randomized (simple) without replacement to one of the two study arms, using a pre-determined random number generator in Excel. Participants then completed the pre- questionnaire in a quiet location via a tablet/computer provided by the research team or virtually. There was no time limit for completion of the questionnaire. The survey will feature an item that prompts individuals if they miss a question, but does not force participants to respond. After initial questionnaire completion, participants completed their assigned intervention (decision-based interactive concussion education platform + NCAA concussion education sheet versus NCAA education sheet). Immediately following their respective intervention, athletes completed the questionnaire again. Upon completing the post-intervention questionnaire, the participant's participation in the study is complete and they will receive an incentive. Following each survey, a research team member will verify and assess for missing answers, allowing participants to complete any missed questions that they wish to answer. Two weeks following the post-intervention survey, participants will be contacted again to complete the same questionnaire to assess retention of concussion knowledge, perceived norms, attitudes, and behavioral intentions. At this two-week post time point, participants will be informed of the true purpose of the study and be provided access to the BANK (Behaviors, Attitudes, Norms, and Knowledge) platform.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rostered club sport and/or recreational athletes at a single institution will be recruited for participation in this study.

Exclusion criteria

  • There are no additional exclusion criteria for rostered club and intramural athletes at the study institution

Treatment and study plan

NCAA education sheet

Behavioral

A fact sheet that includes information about basic signs and symptoms of a concussion as well as steps to take if an individual sustains a concussion and reinforces the need to report the injury.

Sham Intervention

Behavioral

An approximately 7-minute video that includes information about basic sports nutrition facts.

Decision-based interactive concussive education platform

Behavioral

A platform grounded in theoretical frameworks including the socioecological model and theory of planned behavior. It includes a short video to provide an overview of key lessons, a short quiz, and additional resource links that conclude the module.

Primary outcomes

  1. Perceived Behavioral Norms Change Score

    Time frame: From pre to post intervention, an approximate total of up to thirty minutes.

    Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. The difference between the intervention and post-intervention total score is calculated to compute a change score.Scoring scale ranges from a minimum of 7 to a maximum of 49, where higher scores indicate more favorable perceived norms.

  2. Behavioral Intention Change Score

    Time frame: From pre to post intervention, an approximate total of up to thirty minutes.

    Participants are asked a three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. The difference between the pre-intervention and post-intervention score is calculated to compute a change score.Scoring scale ranges from a minimum of 3 to a maximum of 21, where a higher score indicates a better likelihood that an individual will disclose concussion-like symptoms.

Secondary outcomes

  1. Pre-Intervention Concussion Knowledge Score

    Time frame: Within approximately 15 minutes prior to viewing intervention

    Participants are asked thirty-nine questions on a previously validated BANK survey concerning information. regarding signs & symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall concussion knowledge score. Scoring scale ranges from a minimum of 0 to a maximum 39, where a higher score indicated better concussion knowledge.

  2. Pre-intervention Perceived Behavioral Norms Score

    Time frame: Within approximately 15 minutes prior to viewing intervention

    Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. Scoring scale ranges from a minimum of 7 to a maximum 49, where high scores indicate more favorable perceived norms.

  3. Pre-Intervention Attitudes Score

    Time frame: Within approximately 15 minutes prior to viewing intervention

    Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure).Each item is added together to compute an overall attitude score. Scoring scale ranges from a minimum of 6 to a maximum of 42, where higher scores indicate more favorable attitudes.

  4. Pre-Intervention Behavioral Intention Score

    Time frame: Within approximately 15 minutes prior to viewing intervention

    Participants are asked three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. Scoring scale ranges from a minimum of 3 to a maximum of 21, where a higher score indicates a better likelihood to disclose concussion-like symptoms.

  5. Post-Intervention Concussion Knowledge Score

    Time frame: Up to approximately 30 minutes after viewing intervention

    Participants are asked thirty-nine questions on a previously validated BANK survey concerning information regarding signs & symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall knowledge score. The scoring scale ranges from a minimum of 0 to a maximum of 39, where a higher score indicates better concussion knowledge.

  6. Post-intervention Perceived Behavioral Norms Score

    Time frame: Up to approximately 30 minutes after viewing intervention

    Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. Scoring scale ranges from a minimum of 7 to a maximum of 49, where a higher score indicates more favorable perceived norms.

  7. Post-Intervention Attitudes Score

    Time frame: Up to approximately 30 minutes after viewing intervention

    Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure). Each item is added together to compute an overall attitude score. Scoring scale ranges from a minimum of 6 to a maximum of 42, where a higher score indicates more favorable attitudes.

  8. Post-Intervention Behavioral Intention Score

    Time frame: Up to approximately 30 minutes after viewing intervention

    Participants are asked three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. The scoring scale ranges from a minimum of 3 to a maximum of 21, where a higher score indicates a better likelihood that the individual will disclose concussion-like symptoms.

  9. Concussion Knowledge Change Score

    Time frame: From pre to post intervention, an approximate total of up to thirty minutes.

    Participants are asked thirty-nine questions on a previously validated BANK survey concerning information. regarding signs & symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall knowledge score. The difference between the pre-intervention and post-intervention total score is calculated to compute a change score. Scoring scale ranges from a minimum of 0 to a maximum of 39, where higher scores indicate better concussion knowledge.

  10. Attitudes Change Score

    Time frame: From pre to post intervention, an approximate total of up to thirty minutes.

    Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure). Each item is added together to compute an overall attitude score. The difference between the pre-intervention and post-intervention total score is calculated to compute a change score. Scoring scale ranges from a minimum of 6 to a maximum of 42, where higher scores indicate more favorable attitudes.

  11. Concussion Knowledge Retention Score

    Time frame: Within approximately 2 weeks following the viewing of the intervention

    Participants are asked thirty-nine questions on a previously validated BANK survey concerning information. regarding signs & symptoms, diagnosis, treatment, and return to play following a sport-related concussion. Each item is added together to compute an overall knowledge score. The scoring scale ranges from a minimum of 0 to a maximum of 39, where higher scores indicate better concussion knowledge.

  12. Perceived Behavioral Norms Retention Score

    Time frame: Within approximately 2 weeks following the viewing of the intervention

    Participants are asked seven questions on a previously validated BANK survey identifying what an athlete thinks are important to people in his or her environment would do with respect to concussion reporting. Each item is added together to compute an overall perceived behavioral norms score. Scoring scale ranges from a minimum of 7 to a maximum of 49, where higher schools indicate more positive perceived norms.

  13. Attitudes Retention Score

    Time frame: Within approximately 2 weeks following the viewing of the intervention

    Participants are asked six survey items identifying an individual's beliefs about a certain behavior (e.g., concussion disclosure). Each item is added together to compute an overall attitude score. The scoring scale ranges from a minimum of 6 to a maximum of 42, where higher scores indicate more favorable attitudes.

  14. Behavioral Intention Retention Score

    Time frame: Within approximately 2 weeks following the viewing of the intervention

    Participants are asked three questions on a previously validated BANK survey assessing intention to disclose a concussion or concussion-like symptoms. The items are totaled to compute an overall behavioral intention score. The scoring scale ranges from a minimum of 3 to a maximum 21, where a higher score indicates a better likelihood that an individual will disclose concussion-like symptoms.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Comparing and Interactive Concussion Education Platform to Current Education Standards: A Randomized Control Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2019
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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