- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06441461
Informal Caregivers at Work - Phase 2 (PPJob-II)
Mental Health and Occupational Outcomes Among Informal Caregivers at Work - a Danish Nationwide Register-based Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Valby, Denmark, 2500
- Team Working Life Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Danish citizens
All citizens aged 0-25 years and all adults aged 18-67 years residing in Denmark in the period from 2000 to 2008.
|
Employees becoming a primary informal caregiver for a child or an adolescent with mental health problems in the period from 2000 to 2018.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal gross income (Level of analysis: primary informal caregiver)
Time Frame: Up to 10 years of follow-up.
|
Personal gross income is analyzed as series of annual statuses.
|
Up to 10 years of follow-up.
|
|
Employment (Level of analysis: primary informal caregiver).
Time Frame: Up to 10 years of follow-up.
|
Employment is analyzed as series of annual statuses (i.e., number of weeks employed within each year during follow-up).
|
Up to 10 years of follow-up.
|
|
Long-term sickness absence (Level of analysis: primary informal caregiver).
Time Frame: Up to 10 years of follow-up.
|
Long-term sickness absence is analyzed as time-to-event from baseline on the week scale.
|
Up to 10 years of follow-up.
|
|
Mental health (Level of analysis: primary informal caregiver).
Time Frame: Up to 10 years of follow-up.
|
Mental health is analyzed as time-to-event from baseline on the week scale whichever comes first: redeemed psychotropic drug prescriptions, treatment for substance abuse or psychiatric hospital services.
|
Up to 10 years of follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderation of potential associations by psychosocial work environment (Level of analysis: primary informal caregiver)
Time Frame: JEMs were composed of national survey data collected in 2000 and 2005.
|
Moderation of potential association by psychosocial work environment is based on age- and sex-specific job-exposure matrices (JEM).
|
JEMs were composed of national survey data collected in 2000 and 2005.
|
|
Moderation of potential associations by occupational group (Level of analysis: primary informal caregiver).
Time Frame: Annual data in the period between 2000 and 2018.
|
Moderation by occupational group is based on DISCO-88 codes (International Standard Classification of Occupation, Danish version 1988).
|
Annual data in the period between 2000 and 2018.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Johan H Jensen, PhD, Team Working Life Denmark
- Principal Investigator: Johan H Jensen, PhD, Occupational and Environmental Medicine, Copenhagen University Hospital - Bispebjerg & Frederiksberg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TeamWorkingLifeDenmark
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Statistics Denmark's extensive collections of registers contain a significant potential for research and analysis.
In order to use this research and analysis potential in accordance with the current register legislation and Statistics Denmark's data confidentiality principles, Statistics Denmark has established special micro-data schemes (Research Scheme, Authority Scheme and Legislative Model).
Through the micro-data schemes, microdata (i.e. individual/single company data) is made available for specific research, investigation and analysis tasks for authorised research/analysis environments. Foreign research/analysis environments cannot be authorised for the scheme, but under certain conditions, foreign users can access data.
Further information: https://www.dst.dk/en/TilSalg/Forskningsservice/Dataadgang
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.