Comparing and Interactive Concussion Education Platform to Current Education Standards
1 other identifier
interventional
75
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
October 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2022
CompletedNovember 17, 2022
April 1, 2022
2.5 years
October 8, 2019
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Perceived Behavioral Norms Change Score
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.
From pre to post intervention, an approximate total of up to thirty minutes.
Behavioral Intention Change Score
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.
From pre to post intervention, an approximate total of up to thirty minutes.
Secondary Outcomes (14)
Pre-Intervention Concussion Knowledge Score
Within approximately 15 minutes prior to viewing intervention
Pre-intervention Perceived Behavioral Norms Score
Within approximately 15 minutes prior to viewing intervention
Pre-Intervention Attitudes Score
Within approximately 15 minutes prior to viewing intervention
Pre-Intervention Behavioral Intention Score
Within approximately 15 minutes prior to viewing intervention
Post-Intervention Concussion Knowledge Score
Up to approximately 30 minutes after viewing intervention
- +9 more secondary outcomes
Study Arms (2)
Education Sheet and Sham Intervention
SHAM COMPARATORParticipants will be asked to fill out a pre-intervention survey to assess existing concussion knowledge, perceived norms, attitudes, and behavioral intentions. Afterward, the NCAA concussion education fact sheet will be viewed along with the viewing of the sham intervention. Following the intervention, a post-intervention survey re-assessing the constructs from the pre-intervention survey will be completed. May be completed in-person or virtually.
Education Sheet and Decision-based interactive intervention
EXPERIMENTALParticipants will be asked to fill out a pre-intervention survey to assess existing concussion knowledge, perceived norms, attitudes, and behavioral intentions. Afterward, the NCAA concussion education fact sheet will be viewed along with the viewing of a decision- based interactive concussion education platform intervention. Following the intervention, a post-intervention survey re-assessing the constructs from the pre-intervention survey will be completed. May be completed in-person or virtually.
Interventions
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.
An approximately 7-minute video that includes information about basic sports nutrition facts.
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.
Eligibility Criteria
You may qualify if:
- Rostered club sport and/or recreational athletes at a single institution will be recruited for participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johna K Register-Mihalik, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 10, 2019
Study Start
October 21, 2019
Primary Completion
April 21, 2022
Study Completion
April 21, 2022
Last Updated
November 17, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 9 to 36 months following publication
- Access Criteria
- IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.