NCT03678077

Brief Summary

Mild traumatic brain injury (mTBI) accounts for 70-90% of all diagnosed traumatic brain injuries (TBI) affecting approximately 50-300 per 100.000 individuals annually. Persistent post-concussion symptoms are reported in 15-80% of hospital admitted and outpatient treated populations, affecting labour market attachment, academic achievement, income, socio-economic status, social interactions, home management, leisure activities and cohabitation status. The association between mTBI and long-term trends in cohabitation status, income, academic achievement and socio-economic status has not been thoroughly explored. Previous studies focus on children's academic performance after severe TBI and only few studies include early adulthood and patients with mTBI. Trends in divorce rates are frequently conducted on severe injuries or populations consisting of veterans. Additionally, all studies have failed to apply a national register based design. Aim The aim of the study is to examine the long-term associations between mTBI and trends in cohabitation status, academic achievement and socio-economic status between pre-injury rates and observed rates at 5 years post-injury. The hypothesis was that by 5 years mTBI would be associated with increased odds of marital breakdown, decreasing academic achievement, decreasing income, decreasing socio-economic status compared to the general population in Denmark. Methods: The study is a national register based cohort study with 5 years follow-up of patients with mild traumatic brain injury from 2008 - 2012 in Denmark. Population: Patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) were extracted from the Danish National Patient Register between (2003-2007). Patients with major neurological injuries and previous concussions at the index date and 5 years before the index date (1998-2007) were excluded. Patients who were not resident in Denmark 5 years before and during the inclusion period were also excluded (1998-2007). Data will be retrieved from several national databases, including: the Danish national patient register, Danish Civil Registration System (CRS), the Danish Education Registers, the Income Statistics Register and the Employment Classification Module (AKM). One control of the general population were matched for each case on sex, age and municipality. Outcome measures are: Cohabitation status, Education, income and socio-economic status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45,777

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

September 18, 2018

Last Update Submit

March 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cohabitation status

    Data comprise four definitions of married couples, registered partnerships, couples living in consensual union, cohabiting couple or being single. Data were consolidated into married/cohabiting couple or single status.

    5 years follow-up (2008-2012)

Secondary Outcomes (3)

  • Education

    5 years follow-up (2008-2012)

  • Income

    5 years follow-up (2008-2012)

  • Socioeconomic status

    5 years follow-up (2008-2012)

Study Arms (2)

Mild traumatic brain injury

Patients between 18-60 years, who were hospital admitted, emergency or outpatient treated with mild traumatic brain injury (ICD-10 S06.0). Data were extracted from the Danish national patient register from January 2003 - December 2007. Patients who were not resident in Denmark 5 years before and during the inclusion period were excluded (1998-2007).

Other: Mild traumatic brain injury

Matching controls

Matching controls without concussion of the same age, from the same municipality and of same gender as the included cases. Controls were included during 2003 - 2007. Data were extracted from the population register. Controls who were not resident in Denmark 5 years before and during the inclusion period were excluded (1998-2007).

Interventions

This is a register based observational study and does not include interventions. Exposure is mild traumatic brain injury.

Mild traumatic brain injury

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Hospital admitted, emergency or outpatient treated patients between 18-60 years diagnosed with concussion (ICD-10 S06.0) are extracted from the Danish National Patient Registre between (2003-2007).

You may qualify if:

  • Concussion (ICD-10 S06.0) (primary diagnosis)(2003-2007)

You may not qualify if:

  • Major neurological injuries and previous concussions (1998-2007)
  • Not resident in Denmark (1998-2007)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Copenhagen

Copenhagen, DK, 1353, Denmark

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 Officials

  • Hana M Rytter

    Department of Psychology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd student

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 19, 2018

Study Start

September 20, 2018

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

March 14, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations