NCT03544372

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

May 21, 2018

Last Update Submit

June 5, 2018

Conditions

Keywords

concussion, rugby, self-report, concussion history, reliability

Outcome Measures

Primary Outcomes (1)

  • 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

    30 minutes

Interventions

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

current professional rugby union players

You may qualify if:

  • \> 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.

You may not qualify if:

  • Any players with a history of non-sports related concussion/severe traumatic brain injury due to road traffic collisions etc. will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trinity College Dublin

Dublin, Ireland

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator, Ms Joice Cunningham (Phd Candidate)

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 1, 2018

Study Start

March 15, 2017

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

June 7, 2018

Record last verified: 2018-06

Locations