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临床试验/NCT04122274
NCT04122274已完成不适用

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

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Perceived Behavioral Norms Change Score

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Education Sheet and Sham Intervention

Sham Comparator

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.

干预措施: NCAA education sheet (Behavioral)

Education Sheet and Sham Intervention

Sham Comparator

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.

干预措施: Decision-based interactive concussive education platform (Behavioral)

Education Sheet and Decision-based interactive intervention

Experimental

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.

干预措施: NCAA education sheet (Behavioral)

Education Sheet and Decision-based interactive intervention

Experimental

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.

干预措施: Sham Intervention (Behavioral)

结局指标

主要结局

Perceived Behavioral Norms Change Score

时间窗: 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.

Behavioral Intention Change Score

时间窗: 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.

次要结局

  • Pre-Intervention Behavioral Intention Score(Within approximately 15 minutes prior to viewing intervention)
  • Pre-intervention Perceived Behavioral Norms Score(Within approximately 15 minutes prior to viewing intervention)
  • Post-intervention Perceived Behavioral Norms Score(Up to approximately 30 minutes after viewing intervention)
  • Post-Intervention Behavioral Intention Score(Up to approximately 30 minutes after viewing intervention)
  • Pre-Intervention Attitudes Score(Within approximately 15 minutes prior to viewing intervention)
  • Attitudes Retention Score(Within approximately 2 weeks following the viewing of the intervention)
  • Post-Intervention Concussion Knowledge Score(Up to approximately 30 minutes after viewing intervention)
  • Concussion Knowledge Retention Score(Within approximately 2 weeks following the viewing of the intervention)
  • Behavioral Intention Retention Score(Within approximately 2 weeks following the viewing of the intervention)
  • Pre-Intervention Concussion Knowledge Score(Within approximately 15 minutes prior to viewing intervention)
  • Post-Intervention Attitudes Score(Up to approximately 30 minutes after viewing intervention)
  • Concussion Knowledge Change Score(From pre to post intervention, an approximate total of up to thirty minutes.)
  • Attitudes Change Score(From pre to post intervention, an approximate total of up to thirty minutes.)
  • Perceived Behavioral Norms Retention Score(Within approximately 2 weeks following the viewing of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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