<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02249533</url>
  </required_header>
  <id_info>
    <org_study_id>HD080377</org_study_id>
    <nct_id>NCT02249533</nct_id>
  </id_info>
  <brief_title>Evaluation of Spot Light: A Concussion Injury Management App for Youth Sports</brief_title>
  <acronym>SpotLight</acronym>
  <official_title>Evaluation of Spot Light: A Concussion Injury Management App for Youth Sports</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lara McKenzie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sports-related traumatic brain injuries (TBIs), including mTBIs-commonly referred to as&#xD;
      concussions-are a serious public health concern. Diagnostic criteria and consensus return to&#xD;
      play (RTP) guidelines exist, but clinicians have varying approaches to the diagnosis and&#xD;
      management of sports-related concussion as these guidelines are almost completely unsupported&#xD;
      by an evidence base. It is well known that by increasing awareness of concussion signs and&#xD;
      symptoms as well as the importance of addressing this injury, improving coaching on proper&#xD;
      sports activity techniques and good sportsmanship, providing appropriate protective&#xD;
      equipment, and quickly responding to injuries, the incidence, severity, and long-term&#xD;
      negative health effects of sports-related concussion among children and adolescents can be&#xD;
      reduced. The overall objective of this application, which is the first step toward attainment&#xD;
      of our long-term goal, is to evaluate the effectiveness of Spot Light (a concussion injury&#xD;
      management application [app] that coordinates diagnosis, management, and RTP procedures from&#xD;
      injury to safe return to sport) when utilized by youth football teams. Our central hypothesis&#xD;
      is that youth football teams randomized to receive SpotLight will report increased rates of&#xD;
      concussion, increased referrals to physicians for care, and increased athlete compliance with&#xD;
      RTP guidelines. The rationale that underlies the proposed research is that providing an easy&#xD;
      to-use app has a high probability of effectively helping people involved with youth sports&#xD;
      better recognize, respond to, and ensure athletes are fully recovered from sports-related&#xD;
      concussion. We will test our hypothesis by pursuing the following aims: 1: Evaluate whether&#xD;
      Spot Light will increase reported rates of sports-related concussion; Aim 2: Evaluate whether&#xD;
      Spot Light increases referrals to physicians following concussion; Aim 3: Evaluate whether&#xD;
      Spot Light improves the management of sports-related concussion. We expect to determine&#xD;
      whether there is increased reporting, referrals to physicians, and athlete compliance with&#xD;
      RTP guidelines. This contribution will be significant because it will allow physicians,&#xD;
      athletic trainers (ATs), coaches, and parents to collaboratively track concussions from&#xD;
      injury through safe RTP thereby lessening the chances of long-term negative outcomes as well&#xD;
      as acute catastrophic outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sports-related traumatic brain injuries (TBIs), including mTBIs - commonly referred to as&#xD;
      concussions - are a serious public health concern. During the last decade, emergency&#xD;
      department visits for sports and recreation related TBIs among youth, including concussions,&#xD;
      increased by 62%.[1] Concussion rates among high school athletes have significantly increased&#xD;
      over the past decade.[2] Although most sports-related concussions are mild injuries where the&#xD;
      athlete fully recovers from symptoms within a week, [3-5] each year TBIs contribute to a&#xD;
      substantial number of deaths and cases of permanent disability. While contact sports such as&#xD;
      football have the highest incidence and rates of concussion, these injuries occur across a&#xD;
      wide range of sports.[5] Diagnostic criteria and consensus return to play (RTP) guidelines&#xD;
      exist, but clinicians have varying approaches to the diagnosis and management of&#xD;
      sports-related concussions as these guidelines are almost completely unsupported by an&#xD;
      evidence base. Increasing awareness of concussion signs and symptoms, improving sport&#xD;
      specific coaching techniques, promoting good sportsmanship, providing appropriate protective&#xD;
      equipment and responding quickly to injuries reduces the incidence, severity and long-term&#xD;
      negative health effects of sports related concussions among children and adolescents.[1] Thus&#xD;
      there is a critical need for the development of tools for prevention. Our long-term goal is&#xD;
      to reduce the negative consequences of sports-related concussions, specifically in youth&#xD;
      sports. The overall objective of this application, which is the first step toward attainment&#xD;
      of our long-term goal, is to evaluate the effectiveness of Spot Light (a concussion injury&#xD;
      management application [app] that organizes and coordinates diagnosis, management, and RTP&#xD;
      procedures from injury to safe return to sport) (Appendix 1) when utilized by middle and high&#xD;
      school football teams. Our central hypothesis is that middle and high school football teams&#xD;
      randomized to receive Spot Light will report increased rates of concussion; increased&#xD;
      referrals to physicians for care, and increased athlete compliance with RTP guidelines. The&#xD;
      rationale that underlies the proposed research is that providing an easy-to-use app for&#xD;
      sports-related concussions has a high probability of effectively helping people involved with&#xD;
      youth sports better recognize, respond to, and ensure that athletes are fully recovered from&#xD;
      sports-related concussion.&#xD;
&#xD;
      We plan to test our central hypothesis and, thereby, attain the objective of this application&#xD;
      by pursuing the following specific aims: Aim 1. Evaluate whether or not Spot Light increases&#xD;
      reported rates of sports-related concussions.&#xD;
&#xD;
      Working Hypothesis-teams using Spot Light will report a higher rate of concussion than teams&#xD;
      without Spot Light.&#xD;
&#xD;
      Aim 2. Evaluate whether or not Spot Light increases referrals to physicians for patient care&#xD;
      following a sports-related concussion. Working Hypothesis-teams using Spot Light will refer&#xD;
      more concussed athletes for treatment by a physician than teams without Spot Light.&#xD;
&#xD;
      Aim 3. Evaluate whether or not Spot Light improves management of sports-related concussions.&#xD;
&#xD;
      Working Hypothesis-injured athletes on teams utilizing Spot Light will exhibit higher&#xD;
      compliance with RTP guidelines, than teams without Spot Light.&#xD;
&#xD;
      It is anticipated that these aims will yield the following expected outcomes. We expect to&#xD;
      determine whether there is increased reporting of concussion, referrals to physicians, and&#xD;
      athlete compliance with RTP guidelines. We also expect to learn whether the app is adopted&#xD;
      and utilized similarly when distributed to different levels of youth sports (middle vs. high&#xD;
      school age) and different types of &quot;reporters&quot; (coaches vs. certified athletic trainers). We&#xD;
      expect widespread effectiveness across age groups and types of reporters; these results would&#xD;
      suggest that Spot Light is suitable for widespread distribution across a variety of youth&#xD;
      sports and settings. These outcomes are expected to have an important positive impact because&#xD;
      timely and proper diagnosis, management, and coordination of care and RTP decisions will&#xD;
      ultimately reduce the negative consequences and impact of sports-related concussions, as will&#xD;
      now be detailed in the next section.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central Hypothesis/Study Aim 1: Rates of Reported Concussions</measure>
    <time_frame>1 year (football season)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific Aim 2: Physician Referrals</measure>
    <time_frame>1 year (football season)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific Aim 3: Management of Concussions</measure>
    <time_frame>1 year (football season)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>TBI</condition>
  <arm_group>
    <arm_group_label>Spot Light and High School RIO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control: Certified Athletic Trainers will be given access to report football injuries via High School RIO.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spot Light Concussion App</intervention_name>
    <description>Certified Athletic Trainers will report football injuries using High School RIO and will report possible concussions using the Spot Light concussion app.</description>
    <arm_group_label>Spot Light and High School RIO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  middle school or high school aged athletes&#xD;
&#xD;
          -  &quot;reporter&quot; must have an iOS device, such as an iPhone, iPad, etc., and a valid email&#xD;
             address&#xD;
&#xD;
          -  reporter must be comfortable answering questions in English&#xD;
&#xD;
          -  reporter must be willing to utilize the RIO™ system weekly throughout the season&#xD;
&#xD;
          -  reporter must be willing to download the Spot Light app if randomized into the IG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  already currently enrolled in the study under a different condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lara B McKenzie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Injury Research and Policy The Research Insititute at Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Injury Research and Policy, Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Lara McKenzie</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Spot Light</keyword>
  <keyword>High School RIO</keyword>
  <keyword>Concussion</keyword>
  <keyword>Injury Prevention</keyword>
  <keyword>Football</keyword>
  <keyword>Pop Warner</keyword>
  <keyword>High School</keyword>
  <keyword>Middle School</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02249533
org study id: HD080377
nct id: NCT02249533
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Central Hypothesis/Study Aim 1: Rates of Reported Concussions
time frame: 1 year (football season)
description: 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.
measure: Specific Aim 2: Physician Referrals
time frame: 1 year (football season)
description: 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.
measure: Specific Aim 3: Management of Concussions
time frame: 1 year (football season)
description: 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.
arm group label: Spot Light and High School RIO
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: No Intervention
description: Control: Certified Athletic Trainers will be given access to report football injuries via High School RIO.
intervention type: Other
intervention name: Spot Light Concussion App
description: Certified Athletic Trainers will report football injuries using High School RIO and will report possible concussions using the Spot Light concussion app.
arm group label: Spot Light and High School RIO
criteria: 
gender: All
minimum age: 10 Years
maximum age: 19 Years
healthy volunteers: No
last name: Lara B McKenzie, PhD
role: Principal Investigator
affiliation: Center for Injury Research and Policy The Research Insititute at Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Lara McKenzie
investigator title: Principal Investigator