Clinical trial NCT06441461: Informal Caregivers at Work - Phase 2
Official title: Mental Health and Occupational Outcomes Among Informal Caregivers at Work - a Danish Nationwide Register-based Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Work-Related Stress
Keywords: Mental health issue
Work-related illness
Loss of career progression
Lead sponsor: Team Working Life Denmark
Sponsor class: INDUSTRY
Collaborators: name: Bispebjerg Hospital
name: Herlev and Gentofte Hospital
name: HMW Health and Communication
name: National Research Centre for the Working Environment, Denmark
First posted: 2024-06-04
Enrollment: 4386647
Sex: ALL
Minimum age (years): 0
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a nationalwide register-based study of occupational and mental health outcomes of all adult caregivers to children with and without mental health problems.

Brief summary: Mental health problems are rising among children and adolescents. This may not only impact the child's level of daily functioning but also close family members. Informal caregiving is defined as unpaid care for a sick, disabled, or other closely related person. Providing long-term informal care has been associated with detrimental stress-related outcomes, and being simultaneously active in the labor market has been highlighted as an increased burden for the caregiver. Workplaces are poorly suited for dealing with private stressors despite their potential negative consequences for the caregiver's job status and health. There is a need for improving understanding of how long-term informal caregiving impacts job and health outcomes, as well as for measures minimizing potential negative consequences among at-risk occupational groups.

Detailed description: This Danish nationwide observational cohort study examines the associations between employees being a primary informal caregiver for a child or adolescent with mental health problems and the employees' occupational and health outcomes. In addition, we seek to identify modifying psychosocial risk factors at work as well as at-risk occupational groups. The study relies on pre-existing longitudinal data extracted from Danish national registers, including highly reliable information on occupational status, birth information, residence, public transfer payments, income, psychiatric treatment and services, treatment for substance abuse, psychotropic prescription drugs redeemed, as well as background information. In Denmark, all citizens are assigned with a unique identification number enabling merging of national register data included. Caregiver-child relationships are established based on merging of data from birth and household registers. In this study, register data are further merged with information on psychosocial work environment based on national survey data. All data are located at Statistics Denmark, and accessed and analyzed via a logged, secured platform, The Danish Occupational Cohort (DOC\*X) (www.DOC-X.dk). Exposed employees are compared to a reference group of employees without mental health problems at the familiy level matched according to age group, gender (female/male), and socio-occupational status.

Eligibility criteria: Inclusion Criteria:

* Children/adolescents: Citizens aged 0-25 years in the period between 2000 and 2018. Mental disorder is indicated by redeeming of psychotropic medication, treatment for substance abuse, and psychiatric services. Children of reference adult caregivers is defined by having no personal history of a mental disorder. We exclude children born outside of Denmark.
* Adults: Citizens aged 18-67 years residing in Denmark, partaking in the work force in the period between 2000-2008, and living with a child in the household at any time until the child's 18th year or being a parent to a child at its birth.

Exclusion Criteria:

* We exclude all citizens born in the Faroe Islands and in Greenland. We exclude all citizens residing in the Faroe Islands and in Greenland in the period between 2000 and 2018.

Primary outcomes:
measure: Personal gross income (Level of analysis: primary informal caregiver)
timeFrame: Up to 10 years of follow-up.
measure: Employment (Level of analysis: primary informal caregiver).
timeFrame: Up to 10 years of follow-up.
measure: Long-term sickness absence (Level of analysis: primary informal caregiver).
timeFrame: Up to 10 years of follow-up.
measure: Mental health (Level of analysis: primary informal caregiver).
timeFrame: Up to 10 years of follow-up.
Secondary outcomes:
measure: Moderation of potential associations by psychosocial work environment (Level of analysis: primary informal caregiver)
timeFrame: JEMs were composed of national survey data collected in 2000 and 2005.
measure: Moderation of potential associations by occupational group (Level of analysis: primary informal caregiver).
timeFrame: Annual data in the period between 2000 and 2018.
Other outcomes:
Locations:
city: Valby
country: Denmark
facility: Team Working Life Denmark
Study officials:
affiliation: Team Working Life Denmark
name: Johan H Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Occupational and Environmental Medicine, Copenhagen University Hospital - Bispebjerg & Frederiksberg
name: Johan H Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: