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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

Norway1 site
  • University Hospital of Nothern Norway

    Tromsø

Other trials in Norway

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 groups in NCT04000035
Study groupRoleWhat they receive
Health in workExperimentalThe 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 measuresActive comparatorRegular 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.

  1. 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

  2. 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

  3. 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

  4. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted27 Jun 2019
  2. Study start14 Jun 2019
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2035 (estimated)

Resources

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)
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 35388792
  • Terjesen 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

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.

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