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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
Sponsor:
Information provided by (Responsible Party):
Lara McKenzie, Nationwide Children's Hospital

Brief Summary:
Sports-related traumatic brain injuries (TBIs), including mTBIs—commonly referred to as concussions—are a serious public health concern. Diagnostic criteria and consensus return to play (RTP) guidelines exist, but clinicians have varying approaches to the diagnosis and management of sports-related concussion as these guidelines are almost completely unsupported by an evidence base. It is well known that by increasing awareness of concussion signs and symptoms as well as the importance of addressing this injury, improving coaching on proper sports activity techniques and good sportsmanship, providing appropriate protective equipment, and quickly responding to injuries, the incidence, severity, and long-term negative health effects of sports-related concussion among children and adolescents can be reduced. The overall objective of this application, which is the first step toward attainment of our long-term goal, is to evaluate the effectiveness of Spot Light (a concussion injury management application [app] that coordinates diagnosis, management, and RTP procedures from injury to safe return to sport) when utilized by youth football teams. Our central hypothesis is that youth football teams randomized to receive SpotLight will report increased rates of concussion, increased referrals to physicians for care, and increased athlete compliance with RTP guidelines. The rationale that underlies the proposed research is that providing an easy to-use app has a high probability of effectively helping people involved with youth sports better recognize, respond to, and ensure athletes are fully recovered from sports-related concussion. We will test our hypothesis by pursuing the following aims: 1: Evaluate whether Spot Light will increase reported rates of sports-related concussion; Aim 2: Evaluate whether Spot Light increases referrals to physicians following concussion; Aim 3: Evaluate whether Spot Light improves the management of sports-related concussion. We expect to determine whether there is increased reporting, referrals to physicians, and athlete compliance with RTP guidelines. This contribution will be significant because it will allow physicians, athletic trainers (ATs), coaches, and parents to collaboratively track concussions from injury through safe RTP thereby lessening the chances of long-term negative outcomes as well as acute catastrophic outcomes.

Condition or disease Intervention/treatment Phase
TBI Other: Spot Light Concussion App Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • middle school or high school aged athletes
  • "reporter" must have an iOS device, such as an iPhone, iPad, etc., and a valid email address
  • reporter must be comfortable answering questions in English
  • reporter must be willing to utilize the RIO™ system weekly throughout the season
  • reporter must be willing to download the Spot Light app if randomized into the IG

Exclusion Criteria:

  • already currently enrolled in the study under a different condition

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Center for Injury Research and Policy, Nationwide Children's Hospital
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Lara McKenzie
Investigators
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Principal Investigator: Lara B McKenzie, PhD Center for Injury Research and Policy The Research Insititute at Nationwide Children's Hospital

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Responsible Party: Lara McKenzie, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02249533     History of Changes
Other Study ID Numbers: HD080377
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Lara McKenzie, Nationwide Children's Hospital:
Spot Light
High School RIO
Concussion
Injury Prevention
Football
Pop Warner
High School
Middle School