Musculoskeletal PainHiAforskNCT04000035
Health in Work - a Measure for Increased Coping and Work Inclusion
A study testing Health and work environment information and processes in people with Musculoskeletal Pain and Mental Health Wellness 1, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Health in work - a measure for increased coping and work participation -An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Mental Health Wellness 1, Work-Related Condition
- What is being tested?
- Health and work environment information and processes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,383 participants
- Where
- 1 siteNorway
- Study dates
- 14 Jun 2019to 1 Jul 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum 8 employees
- accessible data on sickness absence (both self- and physician-certified) in the workplace/workplace unit for the past two years prior to inclusion
- all staff employed > 20% in the participating workplaces/workplace units
- Norwegian-speaking
Who cannot join
- ongoing profound reorganisation at the workplace/workplace unit (>20% change of employees within workplace unit)
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health in Work - a Measure for Increased Coping and Work Inclusion - An Analysis of Effect of Preventive Information Given at the Workplace - Part 1: Quantitative Data Collection
Health in work - a measure for increased coping and work participation
-An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection
Read more
The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national programme Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.
The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the Health in work intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.
Read the detailed description
The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national concept Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.
The interdisciplinary Health in work intervention consists of three information sessions over the course of one year, with work place processes in between. In the meetings, structured health information about musculoskeletal- and mental disorders is given and put in the context of working and the specific workplace. This includes possibilities to work despite health impairment, work inclusion measures, and discussion on how these could have an influence on the individual, group, management and organizational level. The process involves the workplaces' entire staff (employers and employees). It is an active process and workplaces are stimulated and expected to continue to work with these topics both between sessions and after the last meeting. The interdisciplinary intervention is carried out in a collaboration of qualified personnel from The Norwegian labour and welfare service (NAV) and qualified health personnel from the hospital department of rehabilitation medicine.
The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. Conventional workplace measures are given by personnel of NAV workplace service without specialist healthcare involvement, focusing mainly on work inclusion and psychosocial work environment. There are several types of interventions available and they will be customized to the workplace. This means that the control intervention is not standardized and will be varying according to the workplaces' demands.
Participating workplaces are recruited through NAV's conventional contact with workplaces based on an analysis of the workplaces' needs. In the workplaces or workplace units that are interested in participating in the project, the following will be distributed to all staff- including leaders- through the employers' email-list: Information about the project, the informed consent-form and a link to the first electronic questionnaire (Q1). The electronic questionnaire portal is open to answers for two weeks after the initial email. After this time period, the workplaces are randomized to either Health in work or control intervention. A one year intervention period follows as described above. The questionnaire is repeated 12 months (Q2) and 24 months (Q3) after randomization. Q1-3 include the same questions regarding health complaints, health mastering, health related quality of life, and work environment.
Work participation will be assessed at the unit level by data from the employers' sickness absence registers that include both self- and physician-certified sickness absence. Physician-certified sickness absence at the individual level will be gathered from the National register of sickness absence over a four year period from 2 years before randomization to 2 years after. Individual sickness absence will also be assessed by self-report from the questionnaires, considering the last three months prior to the questionnaire.
Data on healthcare utilization at the individual level will be obtained as self-reported data from the questionnaires, as well as objective data from the national register of control and health service refunds (KUHR database) and the Norwegian Patient Register (NPR). These registers include registrations of visits to general practitioners, emergency clinics, physiotherapists, radiologic- laboratory- and psychology/psychiatry and other specialised healthcare services. The study will use the registers' data on number of consultations and costs related to these.
All stakeholders involved in the interventions (workplaces/workplace units, specialist healthcare service and NAV) will keep records of the time used on the interventions (attendance, preparation, implementation, supplementary work, others). Costs related to the different interventions will be assessed from these reports.
Other outcome measures are based on self-reported questionnaire data including health-related quality of life, self-rated health, psychosocial work environment, subjective health complaints, health anxiety, social support and job satisfaction, described in more detail in the outcome section.
Health-economics analyses will be performed on these data in order to determine the cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.
This project has a second part not registered here, gathering qualitative data about the Health in work intervention. This will investigate how the intervention works, what the participants´ impression of the intervention is and how the intervention can best be implemented, considering its planned future nationwide application.
CHANGE FROM 2020: Due to the global pandemic, the study was completely halted for a period of 6 months from mid-March through September 2020. Activity was slowly regained after that, but remained on a lower level than normal, fluctuating with changing infection rates in the region. Due to this, there were delays in both collection of informed-consent forms and allocation of workplace units, and the intervention period was prolonged. Consequently, the time-frame between questionnaires one and two was expanded, in collaboration with the reference group and approved by the steering committee. For units included before March 12th 2020, questionnaire Q2 and Q3 will be delayed by 12 months in order to assure that intervention activities can be carried out. For units included in the second half of 2020 the scheduled delay of questionnaire Q2 and Q3 will be 6 months. Units included in 2021 are expected to follow the one year intervention plan. We will take this into consideration in the final statistical analysis.
- Being tested
- Health and work environment information and processes
- Keywords
- sickness absence, psychosocial work environment
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and work environment information and processesOther
see arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Health in work | Experimental | The interdisciplinary Health in work intervention consists of three information sessions over the course of one year, with work place processes in between. In the meetings, structured health information about musculoskeletal- and mental disorders is given and put in the context of working and the specific workplace. It is an integrated intervention where information is given together by both healthcare- and NAV-personnel. Receives: Other: Health and work environment information and processes |
| Regular work place measures | Active comparator | Regular work place measures offered by NAV workplace service. Those are interventions given by NAV personnel without healthcare involvement and can be varying. Receives: Other: Health and work environment information and processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall sickness absence rates (self- and physician-certified) at the workplace (unit level)
Sickness absence data from workplace-registers; Difference-in-difference analyses of sickness absence within and between intervention and control group (% of planned workdays).
Measured: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Change in healthcare utilization
Difference-in-difference analyses of health service refunds from National register of control and health service refunds (KUHR database, Helsedirektoratet) and Norwegian Patient Register (NPR, Helsedirektoratet) within and between intervention and control group.
Measured: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Change in health-related quality of life (HRQoL) by EQ-5D-5L utility value, including EQ-VAS score
Difference-in-difference analyses of HRQoL within and between intervention and control groups by use of EQ-5D/EQ-VAS.The EuroQol descriptive system EQ-5D-5L describes health along five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Participants rate each dimension along five severity levels from no problems (1) to extreme problems (5).The resulting combination (5 to the power of 5 = 3,125 possible combinations) is attached a utility value based on a national value set on a scale from 1(best health) to a 0(or even lower) for worst health.A Norwegian value set is currently being developed.The EQ-VAS (EuroQol vertical visual analogue scale;0 as worst,100 as best possible score) is an integral part that has to be included when using the EQ-5D questionnaire.It offers important, complementary information on respondents' valuations of their HRQoL that are not necessarily captured by use of the 5 dimensional descriptive part of this instrument.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Health-economic analyses
Cost-effectiveness analysis based on primary outcome 3 and cost-benefit analyses based on primary outcome 1 and 2.
Comparing the intervention arms in terms of incremental costs based on direct- and indirect costs related to interventions throughout the intervention period.
Measured: Time period 24 months prior to randomization through 24 months after randomization
Secondary outcomes (8)
Change in physician-certified sickness absence rates (individual level)
Data from the Norwegian national register of sickness absence (NAV sykefraværsregister); Difference-in-difference analyses of individual sickness absence rates within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Change in self-certified sickness absence rates (individual level)
Data from the questionnaires; Difference-in-difference analyses of self-certified sickness absence rates within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in psychosocial work environment by Demand-Control-Support-Questionnaire score
Demand-Control-Support-Questionnaire, short Swedish version (Theorell et al 1991), 11 items on demand and control, and 6 items on support, each with scores 1-4, subscales for demand, control and support. Low scores indicate low demand, control and support. Difference-in-difference analyses of psychosocial work environment within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in social support from colleagues by NDSS-16 score
Nondirective and Directive support Survey (NDSS-16). 16 items scored 1-5. Subscales for directive support (8 items, scale 8-40) and non-directive support (8 items, scale 8-40), the higher the score the more support. Difference-in-difference analyses of social support from colleagues within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in job satisfaction by GJS score
Global Job Satisfaction (GJS). Quinn and Shepard, 1974, 5 items scores 1-5 and 1-3, highest number indicate best job satisfaction. Difference-in-difference analyses of job satisfaction within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in subjective health complaints by SHC score
Subjective Health Complaints (SHC), Eriksen et al. 1999, 29 items scored with 4 levels from 0 (no complaints) to 3 (serious complaints), total score and subscale for mental complaints and musculoskeletal pain. Difference-in-difference analyses of subjective health complaints within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in health anxiety by Whitheley index score
Change in score of the revised version of the Whiteley Index-6 scale (WI-6-R).The WI-6-R includes questions regarding health anxiety covering different dimensions such as self-experienced health concern, frequency and severity of health concerns, influence of media on subjective health concerns and experiencing of health symptoms. Each response is graded on a 0-4 Likert Scale, where "0=not at all" to "4=a great deal", enabling to calculate a product score of maximum 24, a higher value indicating higher level of health anxiety.
Difference-in-difference analyses of health anxiety within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization; comparison with Tromsø Study 7
Change in Satisfaction of life by SWLS score
Satisfaction of life scale (SWLS). Five items where each has response options ranged from 1 (strongly disagree) to 7 (strongly agree), sum score is calculated. The higher the sum score, the higher is the satisfaction of life. Change in sum score of the first 3 items (the last two are sensitive to age). Difference-in-difference analyses of subjective health complaints within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed.
Measured: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start14 Jun 2019
- Primary completion1 Jul 2023
- Study completion1 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups: intervention and control
- Masking
- None (open label)
- Enrolment
- 1,383 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, Norwegian Labour and Welfare Administration, Helse Nord
- Responsible party
- Principal investigator, Anje Höper, MD/PhD, University Hospital of North Norway
- Investigators
- Nils Fleten, Phd, Study director, UiT The artic University of Norway / Norwegian Welfare Service Troms
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000035
- Sponsor's protocol ID
- 2018/2262(REK)
- Acronym
- HiAforsk
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2019
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoper AC, Terjesen CL, Fleten N. Comparing the New Interdisciplinary Health in Work Intervention With Conventional Monodisciplinary Welfare Interventions at Norwegian Workplaces: Protocol for a Pragmatic Cluster Randomized Trial. JMIR Res Protoc. 2022 Apr 7;11(4):e36166. doi: 10.2196/36166.
PubMed 35388792Terjesen CL, Hoper AC, Farbu EH, Olsen JA, Fleten N. Impact of an intersectoral universal workplace intervention on health related quality of life and wellbeing in a pragmatic cluster randomised trial. Sci Rep. 2025 Jul 29;15(1):27715. doi: 10.1038/s41598-025-12221-1.
PubMed 40730635
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health in Work - a Measure for Increased Coping and Work Inclusion - An Analysis of Effect of Preventive Information Given at the Workplace - Part 1: Quantitative Data Collection
- ClinicalTrials.gov ID
- NCT04000035
- Acronym / sponsor ID
- HiAforsk / 2018/2262(REK)
- Keywords
- sickness absence, psychosocial work environment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,383 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso, Norwegian Labour and Welfare Administration, Helse Nord
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2035 (estimated)
- First posted
- 27 Jun 2019 (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.
Health in work - a measure for increased coping and work participation
-An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection
The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national programme Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.
The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the Health in work intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.
Detailed description
The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national concept Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.
The interdisciplinary Health in work intervention consists of three information sessions over the course of one year, with work place processes in between. In the meetings, structured health information about musculoskeletal- and mental disorders is given and put in the context of working and the specific workplace. This includes possibilities to work despite health impairment, work inclusion measures, and discussion on how these could have an influence on the individual, group, management and organizational level. The process involves the workplaces' entire staff (employers and employees). It is an active process and workplaces are stimulated and expected to continue to work with these topics both between sessions and after the last meeting. The interdisciplinary intervention is carried out in a collaboration of qualified personnel from The Norwegian labour and welfare service (NAV) and qualified health personnel from the hospital department of rehabilitation medicine.
The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. Conventional workplace measures are given by personnel of NAV workplace service without specialist healthcare involvement, focusing mainly on work inclusion and psychosocial work environment. There are several types of interventions available and they will be customized to the workplace. This means that the control intervention is not standardized and will be varying according to the workplaces' demands.
Participating workplaces are recruited through NAV's conventional contact with workplaces based on an analysis of the workplaces' needs. In the workplaces or workplace units that are interested in participating in the project, the following will be distributed to all staff- including leaders- through the employers' email-list: Information about the project, the informed consent-form and a link to the first electronic questionnaire (Q1). The electronic questionnaire portal is open to answers for two weeks after the initial email. After this time period, the workplaces are randomized to either Health in work or control intervention. A one year intervention period follows as described above. The questionnaire is repeated 12 months (Q2) and 24 months (Q3) after randomization. Q1-3 include the same questions regarding health complaints, health mastering, health related quality of life, and work environment.
Work participation will be assessed at the unit level by data from the employers' sickness absence registers that include both self- and physician-certified sickness absence. Physician-certified sickness absence at the individual level will be gathered from the National register of sickness absence over a four year period from 2 years before randomization to 2 years after. Individual sickness absence will also be assessed by self-report from the questionnaires, considering the last three months prior to the questionnaire.
Data on healthcare utilization at the individual level will be obtained as self-reported data from the questionnaires, as well as objective data from the national register of control and health service refunds (KUHR database) and the Norwegian Patient Register (NPR). These registers include registrations of visits to general practitioners, emergency clinics, physiotherapists, radiologic- laboratory- and psychology/psychiatry and other specialised healthcare services. The study will use the registers' data on number of consultations and costs related to these.
All stakeholders involved in the interventions (workplaces/workplace units, specialist healthcare service and NAV) will keep records of the time used on the interventions (attendance, preparation, implementation, supplementary work, others). Costs related to the different interventions will be assessed from these reports.
Other outcome measures are based on self-reported questionnaire data including health-related quality of life, self-rated health, psychosocial work environment, subjective health complaints, health anxiety, social support and job satisfaction, described in more detail in the outcome section.
Health-economics analyses will be performed on these data in order to determine the cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.
This project has a second part not registered here, gathering qualitative data about the Health in work intervention. This will investigate how the intervention works, what the participants´ impression of the intervention is and how the intervention can best be implemented, considering its planned future nationwide application.
CHANGE FROM 2020: Due to the global pandemic, the study was completely halted for a period of 6 months from mid-March through September 2020. Activity was slowly regained after that, but remained on a lower level than normal, fluctuating with changing infection rates in the region. Due to this, there were delays in both collection of informed-consent forms and allocation of workplace units, and the intervention period was prolonged. Consequently, the time-frame between questionnaires one and two was expanded, in collaboration with the reference group and approved by the steering committee. For units included before March 12th 2020, questionnaire Q2 and Q3 will be delayed by 12 months in order to assure that intervention activities can be carried out. For units included in the second half of 2020 the scheduled delay of questionnaire Q2 and Q3 will be 6 months. Units included in 2021 are expected to follow the one year intervention plan. We will take this into consideration in the final statistical analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups: intervention and control
| Arm | Type | Receives |
|---|---|---|
| Health in work | Experimental | Other: Health and work environment information and processesThe interdisciplinary Health in work intervention consists of three information sessions over the course of one year, with work place processes in between. In the meetings, structured health information about musculoskeletal- and mental disorders is given and put in the context of working and the specific workplace. It is an integrated intervention where information is given together by both healthcare- and NAV-personnel. |
| Regular work place measures | Active comparator | Other: Health and work environment information and processesRegular work place measures offered by NAV workplace service. Those are interventions given by NAV personnel without healthcare involvement and can be varying. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- minimum 8 employees
- accessible data on sickness absence (both self- and physician-certified) in the workplace/workplace unit for the past two years prior to inclusion
- all staff employed > 20% in the participating workplaces/workplace units
- Norwegian-speaking
Key exclusion criteria (2 listed)
- ongoing profound reorganisation at the workplace/workplace unit (>20% change of employees within workplace unit)
- none
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 |
|---|---|---|
| Health and work environment information and processessee arm/group description | Other | Health in work, Regular work place measures |
Primary outcome
Change in overall sickness absence rates (self- and physician-certified) at the workplace (unit level)
Time frame: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Sickness absence data from workplace-registers; Difference-in-difference analyses of sickness absence within and between intervention and control group (% of planned workdays).
Change in healthcare utilization
Time frame: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Difference-in-difference analyses of health service refunds from National register of control and health service refunds (KUHR database, Helsedirektoratet) and Norwegian Patient Register (NPR, Helsedirektoratet) within and between intervention and control group.
Change in health-related quality of life (HRQoL) by EQ-5D-5L utility value, including EQ-VAS score
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Difference-in-difference analyses of HRQoL within and between intervention and control groups by use of EQ-5D/EQ-VAS.The EuroQol descriptive system EQ-5D-5L describes health along five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Participants rate each dimension along five severity levels from no problems (1) to extreme problems (5).The resulting combination (5 to the power of 5 = 3,125 possible combinations) is attached a utility value based on a national value set on a scale from 1(best health) to a 0(or even lower) for worst health.A Norwegian value set is currently being developed.The EQ-VAS (EuroQol vertical visual analogue scale;0 as worst,100 as best possible score) is an integral part that has to be included when using the EQ-5D questionnaire.It offers important, complementary information on respondents' valuations of their HRQoL that are not necessarily captured by use of the 5 dimensional descriptive part of this instrument.
Health-economic analyses
Time frame: Time period 24 months prior to randomization through 24 months after randomization
Cost-effectiveness analysis based on primary outcome 3 and cost-benefit analyses based on primary outcome 1 and 2. Comparing the intervention arms in terms of incremental costs based on direct- and indirect costs related to interventions throughout the intervention period.
8 secondary outcomes
Change in physician-certified sickness absence rates (individual level)
Time frame: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Change in self-certified sickness absence rates (individual level)
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in psychosocial work environment by Demand-Control-Support-Questionnaire score
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in social support from colleagues by NDSS-16 score
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in job satisfaction by GJS score
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in subjective health complaints by SHC score
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Change in health anxiety by Whitheley index score
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization; comparison with Tromsø Study 7
Change in Satisfaction of life by SWLS score
Time frame: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 35388792Hoper AC, Terjesen CL, Fleten N. Comparing the New Interdisciplinary Health in Work Intervention With Conventional Monodisciplinary Welfare Interventions at Norwegian Workplaces: Protocol for a Pragmatic Cluster Randomized Trial. JMIR Res Protoc. 2022 Apr 7;11(4):e36166. doi: 10.2196/36166.
- Derived from this study: PubMed 40730635Terjesen CL, Hoper AC, Farbu EH, Olsen JA, Fleten N. Impact of an intersectoral universal workplace intervention on health related quality of life and wellbeing in a pragmatic cluster randomised trial. Sci Rep. 2025 Jul 29;15(1):27715. doi: 10.1038/s41598-025-12221-1.
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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.
Nils Fleten, Phd study director
UiT The artic University of Norway / Norwegian Welfare Service Troms
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and work environment information and processes in people with Musculoskeletal Pain and Mental Health Wellness 1, run by University Hospital of North Norway at 1 site in Norway.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in overall sickness absence rates (self- and physician-certified) at the workplace (unit level) (time frame: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization). 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 NCT04000035, which also lists 2 linked publications.
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 16 Dec 2024.