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

TBI Clinical Trial

— SpotLight  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249533
• Other study ID #: HD080377
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: January 31, 2017
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Sports-related traumatic brain injuries (TBIs), including mTBIs - commonly referred to as concussions - are a serious public health concern. During the last decade, emergency department visits for sports and recreation related TBIs among youth, including concussions, increased by 62%.[1] Concussion rates among high school athletes have significantly increased over the past decade.[2] Although most sports-related concussions are mild injuries where the athlete fully recovers from symptoms within a week, [3-5] each year TBIs contribute to a substantial number of deaths and cases of permanent disability. While contact sports such as football have the highest incidence and rates of concussion, these injuries occur across a wide range of sports.[5] Diagnostic criteria and consensus return to play (RTP) guidelines exist, but clinicians have varying approaches to the diagnosis and management of sports-related concussions as these guidelines are almost completely unsupported by an evidence base. Increasing awareness of concussion signs and symptoms, improving sport specific coaching techniques, promoting good sportsmanship, providing appropriate protective equipment and responding quickly to injuries reduces the incidence, severity and long-term negative health effects of sports related concussions among children and adolescents.[1] Thus there is a critical need for the development of tools for prevention. Our long-term goal is to reduce the negative consequences of sports-related concussions, specifically in youth sports. 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 organizes and coordinates diagnosis, management, and RTP procedures from injury to safe return to sport) (Appendix 1) when utilized by middle and high school football teams. 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. The rationale that underlies the proposed research is that providing an easy-to-use app for sports-related concussions has a high probability of effectively helping people involved with youth sports better recognize, respond to, and ensure that athletes are fully recovered from sports-related concussion.

We plan to test our central hypothesis and, thereby, attain the objective of this application by pursuing the following specific aims: Aim 1. Evaluate whether or not Spot Light increases reported rates of sports-related concussions.

Working Hypothesis—teams using Spot Light will report a higher rate of concussion than teams without Spot Light.

Aim 2. Evaluate whether or not Spot Light increases referrals to physicians for patient care following a sports-related concussion. Working Hypothesis—teams using Spot Light will refer more concussed athletes for treatment by a physician than teams without Spot Light.

Aim 3. Evaluate whether or not Spot Light improves management of sports-related concussions.

Working Hypothesis—injured athletes on teams utilizing Spot Light will exhibit higher compliance with RTP guidelines, than teams without Spot Light.

It is anticipated that these aims will yield the following expected outcomes. We expect to determine whether there is increased reporting of concussion, referrals to physicians, and athlete compliance with RTP guidelines. We also expect to learn whether the app is adopted and utilized similarly when distributed to different levels of youth sports (middle vs. high school age) and different types of "reporters" (coaches vs. certified athletic trainers). We expect widespread effectiveness across age groups and types of reporters; these results would suggest that Spot Light is suitable for widespread distribution across a variety of youth sports and settings. These outcomes are expected to have an important positive impact because timely and proper diagnosis, management, and coordination of care and RTP decisions will ultimately reduce the negative consequences and impact of sports-related concussions, as will now be detailed in the next section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• TBI

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Injury Research and Policy, Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Lara McKenzie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specific Aim 2: Physician Referrals	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.	1 year (football season)
Secondary	Specific Aim 3: Management of Concussions	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.	1 year (football season)