Work-Related StressPPJob-IINCT06441461
Informal Caregivers at Work - Phase 2
An observational study of Work-Related Stress, run by Team Working Life Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 67 years
- Conditions the study is for
- Work-Related Stress
- What is being tested?
- Primary informal caregiver at work.
- How many people
- 4,386,647 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 67 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental Health and Occupational Outcomes Among Informal Caregivers at Work - a Danish Nationwide Register-based Cohort Study
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.
Read the 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.
- Conditions
- Work-Related Stress
- Being tested
- Primary informal caregiver at work.
- Keywords
- Mental health issue, Work-related illness, Loss of career progression
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary informal caregiver at work.Other
Employees becoming a primary informal caregiver for a child or an adolescent with mental health problems in the period from 2000 to 2018.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Primary informal caregiver at work. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal gross income (Level of analysis: primary informal caregiver)
Personal gross income is analyzed as series of annual statuses.
Measured: Up to 10 years of follow-up.
Employment (Level of analysis: primary informal caregiver).
Employment is analyzed as series of annual statuses (i.e., number of weeks employed within each year during follow-up).
Measured: Up to 10 years of follow-up.
Long-term sickness absence (Level of analysis: primary informal caregiver).
Long-term sickness absence is analyzed as time-to-event from baseline on the week scale.
Measured: Up to 10 years of follow-up.
Mental health (Level of analysis: primary informal caregiver).
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.
Measured: Up to 10 years of follow-up.
Secondary outcomes (2)
Moderation of potential associations by psychosocial work environment (Level of analysis: primary informal caregiver)
Moderation of potential association by psychosocial work environment is based on age- and sex-specific job-exposure matrices (JEM).
Measured: 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).
Moderation by occupational group is based on DISCO-88 codes (International Standard Classification of Occupation, Danish version 1988).
Measured: Annual data in the period between 2000 and 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Work-Related StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,386,647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Team Working Life Denmark
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bispebjerg Hospital, Herlev and Gentofte Hospital, HMW Health and Communication, National Research Centre for the Working Environment, Denmark
- Responsible party
- Sponsor
- Investigators
- Johan H Jensen, PhD, Principal investigator, Team Working Life DenmarkJohan H Jensen, PhD, Principal investigator, Occupational and Environmental Medicine, Copenhagen University Hospital - Bispebjerg & Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441461
- Sponsor's protocol ID
- TeamWorkingLifeDenmark
- Acronym
- PPJob-II
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Jensen JH, Flachs EM, Thorup AAE, Mehlum IAS, Weil HM, Gensby U, Albertsen K. Personal Income Progression of Informal Family Caregivers of Children and Young Adults With Mental Disorders. Scand J Psychol. 2026 Oct 16. doi: 10.1111/sjop.70150. Online ahead of print.
PubMed 42885395
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Occupational Outcomes Among Informal Caregivers at Work - a Danish Nationwide Register-based Cohort Study
- ClinicalTrials.gov ID
- NCT06441461
- Acronym / sponsor ID
- PPJob-II / TeamWorkingLifeDenmark
- Conditions
- Work-Related Stress
- Keywords
- Mental health issue, Work-related illness, Loss of career progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,386,647 participants (actual)
- Lead sponsor
- Team Working Life DenmarkIndustry (pharma, biotech, devices)
- Collaborators
- Bispebjerg Hospital, Herlev and Gentofte Hospital, HMW Health and Communication, National Research Centre for the Working Environment, Denmark
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danish citizens | – | Other: Primary informal caregiver at work.All citizens aged 0-25 years and all adults aged 18-67 years residing in Denmark in the period from 2000 to 2008. |
Who may qualify
- Ages
- 0 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary informal caregiver at work.Employees becoming a primary informal caregiver for a child or an adolescent with mental health problems in the period from 2000 to 2018. | Other | Danish citizens |
Primary outcome
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.
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).
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.
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.
2 secondary outcomes
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 associations by occupational group (Level of analysis: primary informal caregiver).
Time frame: Annual data in the period between 2000 and 2018.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 42885395Jensen JH, Flachs EM, Thorup AAE, Mehlum IAS, Weil HM, Gensby U, Albertsen K. Personal Income Progression of Informal Family Caregivers of Children and Young Adults With Mental Disorders. Scand J Psychol. 2026 Oct 16. doi: 10.1111/sjop.70150. Online ahead of print.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan H Jensen, PhD principal investigator
Team Working Life Denmark
Johan H Jensen, PhD principal investigator
Occupational and Environmental Medicine, Copenhagen University Hospital - Bispebjerg & Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-Related Stress, run by Team Working Life Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal gross income (Level of analysis: primary informal caregiver) (time frame: Up to 10 years of follow-up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06441461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.