Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury

NCT ID: NCT03678077

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45777 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2019-03-13

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.

Conditions

Mild Traumatic Brain Injury; Concussion, Mild; Academic Achievement; Specific Academic or Work Inhibition; Marriage; Marital Status; Income; Education; Socioeconomic Status; Sickness Absence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

Mild traumatic brain injury

Intervention Type: OTHER

This is a register based observational study and does not include interventions. Exposure is 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).

No interventions assigned to this group

Interventions

Mild traumatic brain injury

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Sygekassernes Helsefond

OTHER

Sponsor Role: collaborator

Aase and Ejnar Danielsens Foundation

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Heidi Jeannet Graff

Phd student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hana M Rytter

Role: STUDY_DIRECTOR

Department of Psychology

Locations

Department of Psychology, University of Copenhagen

Copenhagen, DK, Denmark

Countries

Denmark

Other Identifiers

mTBI-HJG-2018

Identifier Type: -

Identifier Source: org_study_id