TBISpotLightNCT02249533
Evaluation of Spot Light: A Concussion Injury Management App for Youth Sports
A study testing Spot Light Concussion App in people with TBI, run by Lara McKenzie at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- TBI
- What is being tested?
- Spot Light Concussion App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- already currently enrolled in the study under a different condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Injury Research and Policy, Nationwide Children's Hospital
Columbus, Ohio, 43215
About this study
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.
Read the detailed 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.
- Conditions
- TBI
- Being tested
- Spot Light Concussion App
- Keywords
- Spot Light, High School RIO, Concussion, Injury Prevention, Football, Pop Warner, High School, Middle School
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spot Light Concussion AppOther
Certified Athletic Trainers will report football injuries using High School RIO and will report possible concussions using the Spot Light concussion app.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Spot Light Concussion App |
| Control | No intervention | Control: Certified Athletic Trainers will be given access to report football injuries via High School RIO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year (football season)
Secondary outcomes (2)
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.
Measured: 1 year (football season)
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.
Measured: 1 year (football season)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lara McKenzie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lara McKenzie, Nationwide Children's Hospital
- Investigators
- Lara B McKenzie, PhD, Principal investigator, Center for Injury Research and Policy The Research Insititute at Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249533
- Sponsor's protocol ID
- HD080377
- Acronym
- SpotLight
- Status last verified
- Jan 2017
- First submitted
- 29 Jan 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spot Light: A Concussion Injury Management App for Youth Sports
- ClinicalTrials.gov ID
- NCT02249533
- Acronym / sponsor ID
- SpotLight / HD080377
- Conditions
- TBI
- Keywords
- Spot Light, High School RIO, Concussion, Injury Prevention, Football, Pop Warner, High School, Middle School
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Lara McKenzieUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spot Light and High School RIO | Experimental | Other: Spot Light Concussion AppA 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. |
| Control | No intervention | –Control: Certified Athletic Trainers will be given access to report football injuries via High School RIO. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- already currently enrolled in the study under a different condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spot Light Concussion AppCertified Athletic Trainers will report football injuries using High School RIO and will report possible concussions using the Spot Light concussion app. | Other | Spot Light and High School RIO |
Primary outcome
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.
2 secondary outcomes
Specific Aim 2: Physician Referrals
Time frame: 1 year (football season)
Specific Aim 3: Management of Concussions
Time frame: 1 year (football season)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara B McKenzie, PhD principal investigator
Center for Injury Research and Policy The Research Insititute at Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spot Light Concussion App in people with TBI, run by Lara McKenzie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Hypothesis/Study Aim 1: Rates of Reported Concussions (time frame: 1 year (football season)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.