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Comparing and Interactive Concussion Education Platform to Current Education Standards

Primary Purpose

Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NCAA education sheet
Sham Intervention
Decision-based interactive concussive education platform
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Concussion, Brain focused on measuring Concussion, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Education Sheet and Sham Intervention

Education Sheet and Decision-based interactive intervention

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Pre-Intervention Concussion Knowledge Score
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.
Pre-intervention Perceived Behavioral Norms 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. Scoring scale ranges from a minimum of 7 to a maximum 49, where high scores indicate more favorable perceived norms.
Pre-Intervention Attitudes Score
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.
Pre-Intervention Behavioral Intention Score
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.
Post-Intervention Concussion Knowledge Score
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.
Post-intervention Perceived Behavioral Norms 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. Scoring scale ranges from a minimum of 7 to a maximum of 49, where a higher score indicates more favorable perceived norms.
Post-Intervention Attitudes Score
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.
Post-Intervention Behavioral Intention Score
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.
Concussion Knowledge Change Score
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.
Attitudes Change Score
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.
Concussion Knowledge Retention Score
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.
Perceived Behavioral Norms Retention 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. Scoring scale ranges from a minimum of 7 to a maximum of 49, where higher schools indicate more positive perceived norms.
Attitudes Retention Score
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.
Behavioral Intention Retention Score
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.

Full Information

First Posted
October 8, 2019
Last Updated
November 16, 2022
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT04122274
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
Keywords
Concussion, Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education Sheet and Sham Intervention
Arm Type
Sham Comparator
Arm Description
Participants 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.
Arm Title
Education Sheet and Decision-based interactive intervention
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
NCAA education sheet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham Intervention
Intervention Description
An approximately 7-minute video that includes information about basic sports nutrition facts.
Intervention Type
Behavioral
Intervention Name(s)
Decision-based interactive concussive education platform
Intervention Description
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 Outcome Measure Information:
Title
Perceived Behavioral Norms Change Score
Description
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.
Time Frame
From pre to post intervention, an approximate total of up to thirty minutes.
Title
Behavioral Intention Change Score
Description
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.
Time Frame
From pre to post intervention, an approximate total of up to thirty minutes.
Secondary Outcome Measure Information:
Title
Pre-Intervention Concussion Knowledge Score
Description
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.
Time Frame
Within approximately 15 minutes prior to viewing intervention
Title
Pre-intervention Perceived Behavioral Norms Score
Description
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.
Time Frame
Within approximately 15 minutes prior to viewing intervention
Title
Pre-Intervention Attitudes Score
Description
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.
Time Frame
Within approximately 15 minutes prior to viewing intervention
Title
Pre-Intervention Behavioral Intention Score
Description
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.
Time Frame
Within approximately 15 minutes prior to viewing intervention
Title
Post-Intervention Concussion Knowledge Score
Description
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.
Time Frame
Up to approximately 30 minutes after viewing intervention
Title
Post-intervention Perceived Behavioral Norms Score
Description
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.
Time Frame
Up to approximately 30 minutes after viewing intervention
Title
Post-Intervention Attitudes Score
Description
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.
Time Frame
Up to approximately 30 minutes after viewing intervention
Title
Post-Intervention Behavioral Intention Score
Description
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.
Time Frame
Up to approximately 30 minutes after viewing intervention
Title
Concussion Knowledge Change Score
Description
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.
Time Frame
From pre to post intervention, an approximate total of up to thirty minutes.
Title
Attitudes Change Score
Description
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.
Time Frame
From pre to post intervention, an approximate total of up to thirty minutes.
Title
Concussion Knowledge Retention Score
Description
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.
Time Frame
Within approximately 2 weeks following the viewing of the intervention
Title
Perceived Behavioral Norms Retention Score
Description
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.
Time Frame
Within approximately 2 weeks following the viewing of the intervention
Title
Attitudes Retention Score
Description
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.
Time Frame
Within approximately 2 weeks following the viewing of the intervention
Title
Behavioral Intention Retention Score
Description
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.
Time Frame
Within approximately 2 weeks following the viewing of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johna K Register-Mihalik, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill

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Comparing and Interactive Concussion Education Platform to Current Education Standards

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