Evaluation of Spot Light: A Concussion Injury Management App for Youth Sports

NCT02249533 | Completed DMC

• 1 other identifier: HD080377
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI

Keywords

Spot Light; High School RIO; Concussion; Injury Prevention; Football; Pop Warner; High School; Middle School

Outcome Measures

Primary Outcomes (1)

• Central Hypothesis/Study Aim 1: Rates of Reported Concussions

  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.

  1 year (football season)

Secondary Outcomes (2)

• Specific Aim 2: Physician Referrals

  1 year (football season)

• Specific Aim 3: Management of Concussions

  1 year (football season)

Study Arms (2)

Spot Light and High School RIO

EXPERIMENTAL

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

Control

NO INTERVENTION

Control: Certified Athletic Trainers will be given access to report football injuries via High School RIO.

Interventions

Spot Light Concussion App OTHER

Certified Athletic Trainers will report football injuries using High School RIO and will report possible concussions using the Spot Light concussion app.

Spot Light and High School RIO

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• already currently enrolled in the study under a different condition

Sponsors & Collaborators

• Lara McKenzie: lead

Study Sites (1)

Center for Injury Research and Policy, Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Lara B McKenzie, PhD

  Center for Injury Research and Policy The Research Insititute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: September 25, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)