Clinical trial NCT04122274: Comparing and Interactive Concussion Education Platform to Current Education Standards
Official title: Comparing and Interactive Concussion Education Platform to Current Education Standards: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Keywords: Concussion, Education
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Perceived Behavioral Norms Change Score
timeFrame: From pre to post intervention, an approximate total of up to thirty minutes.
measure: Behavioral Intention Change Score
timeFrame: From pre to post intervention, an approximate total of up to thirty minutes.
Secondary outcomes:
measure: Pre-Intervention Concussion Knowledge Score
timeFrame: Within approximately 15 minutes prior to viewing intervention
measure: Pre-intervention Perceived Behavioral Norms Score
timeFrame: Within approximately 15 minutes prior to viewing intervention
measure: Pre-Intervention Attitudes Score
timeFrame: Within approximately 15 minutes prior to viewing intervention
measure: Pre-Intervention Behavioral Intention Score
timeFrame: Within approximately 15 minutes prior to viewing intervention
measure: Post-Intervention Concussion Knowledge Score
timeFrame: Up to approximately 30 minutes after viewing intervention
measure: Post-intervention Perceived Behavioral Norms Score
timeFrame: Up to approximately 30 minutes after viewing intervention
measure: Post-Intervention Attitudes Score
timeFrame: Up to approximately 30 minutes after viewing intervention
measure: Post-Intervention Behavioral Intention Score
timeFrame: Up to approximately 30 minutes after viewing intervention
measure: Concussion Knowledge Change Score
timeFrame: From pre to post intervention, an approximate total of up to thirty minutes.
measure: Attitudes Change Score
timeFrame: From pre to post intervention, an approximate total of up to thirty minutes.
measure: Concussion Knowledge Retention Score
timeFrame: Within approximately 2 weeks following the viewing of the intervention
measure: Perceived Behavioral Norms Retention Score
timeFrame: Within approximately 2 weeks following the viewing of the intervention
measure: Attitudes Retention Score
timeFrame: Within approximately 2 weeks following the viewing of the intervention
measure: Behavioral Intention Retention Score
timeFrame: Within approximately 2 weeks following the viewing of the intervention
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Johna K Register-Mihalik, PhD
role: PRINCIPAL_INVESTIGATOR
References: