Evaluation of Spot Light: A Concussion Injury Management App for Youth Sports (SpotLight)
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|ClinicalTrials.gov Identifier: NCT02249533|
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|TBI||Other: Spot Light Concussion App||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of Spot Light: A Concussion Injury Management App for Youth Sports|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
Experimental: Spot Light and High School RIO
A total of 200 youth football teams (100 high school and 100 middle school-aged teams) will be enrolled. Potential participating teams, all high schools eligible to report football data to High School RIO™ as well as all Pop Warner and Middle School sponsored football teams that have a valid e-mail contact, will be e-mailed a letter inviting them to participate (Appendix 3).
Intervention: Certified Athletic Trainers will be given access to report football injuries via High School RIO and will report potential concussions using the Spot Light Concussion app.
Other: Spot Light Concussion App
Certified Athletic Trainers will report football injuries using High School RIO and will report possible concussions using the Spot Light concussion app.
No Intervention: Control
Control: Certified Athletic Trainers will be given access to report football injuries via High School RIO.
- Central Hypothesis/Study Aim 1: Rates of Reported Concussions [ Time Frame: 1 year (football season) ]Our central hypothesis is that middle and high school football teams randomized to receive Spot Light will report increased rates of concussion; increased referrals to physicians for care, and increased athlete compliance with RTP guidelines. We will compare the rates of concussions entered in the RIO system with those entered into the SpotLight Concussion Management System. Concussion rates are calculated by dividing concussion incidence (numerator) by athlete exposures (denominator). Any reportable concussion is one that: occurred as a result of an organized practice or competition during the past week whether or not it resulted in restriction of the athlete's participation. We will compare the intervention and control in terms of the reported concussion rate and the referred concussion events rate per 1,000 athlete-exposures from each team.
- Specific Aim 2: Physician Referrals [ Time Frame: 1 year (football season) ]Aim 2. Evaluate whether or not Spot Light increases referrals to physicians for patient care following a sports-related concussion. We will examine the differences in the number of those referred to physician for follow-up care (yes/no) between our control and intervention group. We will compare the intervention and control in terms of the reported concussion rate and the referred concussion events rate per 1,000 athlete-exposures from each team.
- Specific Aim 3: Management of Concussions [ Time Frame: 1 year (football season) ]Aim 3. Evaluate whether or not Spot Light improves management of sports-related concussions. Data analytic activities for the proposed project will primarily be comprised of two activities: (1) the generation of descriptive information summarizing the sample and its characteristics; and (2) the analyses related to the aims and hypotheses. We will compare the intervention and control on demographic characteristics and other covariates using chi-square tests for categorical variable comparisons and t-tests for continuous variables as a check of the randomization. We will compare the intervention and control in terms of the reported concussion rate and the referred concussion events rate per 1,000 athlete-exposures from each team and the rate of complied events from each team. The number of athletes on each team, and the number of practices and competitions will be considered as covariates in the analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249533
|United States, Ohio|
|Center for Injury Research and Policy, Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Lara B McKenzie, PhD||Center for Injury Research and Policy The Research Insititute at Nationwide Children's Hospital|