Concussion, MildNCT03544372
Reliability of Self-reported Concussion History in Current Rugby Union Players
An observational study of Concussion, Mild, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
Perhaps no issue in sports medicine has attracted so much media attention and academic interest in recent years as the potential long-term neurodegenerative sequelae of sports-related concussion on athlete's brain health. Rugby has a high incidence of concussion. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Assessment of Concussion History using NIH Concussion History Tool
- How many people
- 63 participants
- Where
- 1 siteIreland
- Study dates
- 15 Mar 2017to 20 Dec 2017
- Phase
- Observational
- 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 Any age
- Men only
- Child, Adult, Older adult
Study population: current professional rugby union players
Who may be able to join
- •> 18 years old
- Contracted to Leinster rugby as a professional rugby player
- Players who have given informed consent and are willing to participate in the study.
- Players with a history of sports-related concussion/mild traumatic brain injury.
Who cannot join
- Any players with a history of non-sports related concussion/severe traumatic brain injury due to road traffic collisions etc. will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation Into the Reliability of Self-reported Concussion History in Current Rugby Union Players
Perhaps no issue in sports medicine has attracted so much media attention and academic interest in recent years as the potential long-term neurodegenerative sequelae of sports-related concussion on athlete's brain health. Rugby has a high incidence of concussion. Recent research findings from a cohort of former professional players found that the number of concussions sustained during their professional careers was associated with the rate of diagnosed clinical depression and late-life cognitive impairment. A limitation of these studies is the use of a self-reported history of concussion. The reliability of professional rugby players to recall and self-report concussion history has never been quantified in the literature to date. Imperfect recall can generate bias in epidemiologic studies when the proportion of events recalled is associated with the health end points of interest. Associations observed may be spurious and due to recall bias if athletes differ in their knowledge and recognition of concussion symptomology in a manner that is associated with the health outcome of interest ie. under/overreporting of concussion. It is difficult to estimate the magnitude of the bias in the absence of any "gold-standard" measure of concussion history. Due to these concerns about the quality of self-reported concussion history, the investigators considered that it was important to evaluate the reliability of self-reported concussion history.
Read the detailed description
The primary aim of this study is to investigate the reliability of self-reported concussion history in current rugby union players
Objectives:
The objectives will be to:
Investigate player's self-report history of sports-related concussion (number and nature of concussions) in this elite rugby playing group.
Correlate player self-report with established individual player medical data. Repeat this process approximately 6 months later on a sub sample of this cohort, in order to test the reliability of player's reported concussion.
- Conditions
- Concussion, Mild
- Being tested
- Assessment of Concussion History using NIH Concussion History Tool
- Keywords
- concussion, rugby, self-report, concussion history, reliability
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Concussion History using NIH Concussion History ToolOther
NIH concussion tool
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report Concussion History
reliability study, agreement between self-report history of concussion via the NIH concussion history tool and documented concussion history. The higher the intraclass correlation between the two-the greater the reliability of the NIH concussion tool
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start15 Mar 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joice Cunningham, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544372
- Sponsor's protocol ID
- JCunningham2
- Status last verified
- Jun 2018
- First submitted
- 21 May 2018
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Reliability of Self-reported Concussion History in Current Rugby Union Players
- ClinicalTrials.gov ID
- NCT03544372
- Acronym / sponsor ID
- JCunningham2
- Conditions
- Concussion, Mild
- Keywords
- concussion, rugby, self-report, concussion history, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 1 Jun 2018 (actual)
- 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.
Perhaps no issue in sports medicine has attracted so much media attention and academic interest in recent years as the potential long-term neurodegenerative sequelae of sports-related concussion on athlete's brain health. Rugby has a high incidence of concussion. Recent research findings from a cohort of former professional players found that the number of concussions sustained during their professional careers was associated with the rate of diagnosed clinical depression and late-life cognitive impairment. A limitation of these studies is the use of a self-reported history of concussion. The reliability of professional rugby players to recall and self-report concussion history has never been quantified in the literature to date. Imperfect recall can generate bias in epidemiologic studies when the proportion of events recalled is associated with the health end points of interest. Associations observed may be spurious and due to recall bias if athletes differ in their knowledge and recognition of concussion symptomology in a manner that is associated with the health outcome of interest ie. under/overreporting of concussion. It is difficult to estimate the magnitude of the bias in the absence of any "gold-standard" measure of concussion history. Due to these concerns about the quality of self-reported concussion history, the investigators considered that it was important to evaluate the reliability of self-reported concussion history.
Detailed description
The primary aim of this study is to investigate the reliability of self-reported concussion history in current rugby union players
Objectives:
The objectives will be to:
Investigate player's self-report history of sports-related concussion (number and nature of concussions) in this elite rugby playing group.
Correlate player self-report with established individual player medical data. Repeat this process approximately 6 months later on a sub sample of this cohort, in order to test the reliability of player's reported concussion.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- current professional rugby union players
Key inclusion criteria (4 listed)
- •> 18 years old
- Contracted to Leinster rugby as a professional rugby player
- Players who have given informed consent and are willing to participate in the study.
- Players with a history of sports-related concussion/mild traumatic brain injury.
Key exclusion criteria (1 listed)
- Any players with a history of non-sports related concussion/severe traumatic brain injury due to road traffic collisions etc. will be excluded.
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 |
|---|---|---|
| Assessment of Concussion History using NIH Concussion History ToolNIH concussion tool | Other | – |
Primary outcome
Self-report Concussion History
Time frame: 30 minutes
reliability study, agreement between self-report history of concussion via the NIH concussion history tool and documented concussion history. The higher the intraclass correlation between the two-the greater the reliability of the NIH concussion tool
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 7 Jun 2018.
Related trials for Concussion, Mild
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Mild, run by University of Dublin, Trinity College at 1 site in Ireland.
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 4 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 7 Jun 2018. 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 Ireland. 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?
Self-report Concussion History (time frame: 30 minutes). 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 7 Jun 2018.