Effects of Regulatory Tools on Work Environment and Employee Health

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Effectiveness of the Labour Inspection Authority's Regulatory Tools on Work Environment and Employee Health - Study Protocol for a Cluster Randomized Controlled Trial Among Norwegian Home-care Workers

ClinicalTrials.gov ID

NCT03855163

Acronym / sponsor ID

201700498

Conditions

Occupational Health, Sick Leave, Occupational Exposure

Keywords

Mental Distress, Musculoskeletal Pain, Work-related, Cluster Randomized Trial, Effect Evaluation

Study type

Interventional

Recruitment status

Completed

Enrolment

2,555 participants (actual)

Lead sponsor

National Institute of Occupational Health, NorwayOther government

Collaborators

Norwegian Labour Inspection Authority

Study start

5 Mar 2019 (actual)

Primary completion

30 Nov 2020 (actual)

Study completion

25 Feb 2022 (actual)

First posted

26 Feb 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.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (investigator)

Number of arms

4

Model description

cluster-randomized controlled trial

Who may qualify

Ages

16 to 67 years

Sex

All

Healthy volunteers

Accepted

Age groups

Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Changes in self reported occupational exposures

   Time frame: Self-Reported Occupational Exposures will be assessed 2 months prior to the interventions and 12 months post interventions

   Psychosocial, organizational and mechanical factors at work will be assessed by the General Nordic Questionnaire for Psychological and Social Factors at Work (QPSNordic) and with items adapted from the following questionnaire developed by Statistics Norway: "Working environment, survey on living conditions". The wording of the questions are typically: "how often in your job do you have to … " (e.g. suppress emotions in order to appear neutral on the outside?), or "In the course of your work" ... (e.g. do you need to squat or kneel?). Level of exposure is assessed by frequency scoring on a five-point scale ranging from "1 = very seldom or never" to "5 = very often or always"

2. Changes in psychological distress HSCL-5

   Time frame: Psychological Distress will be assessed 2 months prior to the interventions and 12 months post interventions

   Hopkins Symptom Checklist (HSCL-5), is a self-administered 5-item instrument, each item is on a four-point scale ranging from 1="not at all" to 4="extremely". Participants are asked to assess symptoms during the past 2 weeks prior to answering the questionnaire. The average item score is calculated by dividing the total score of the number of items answered (ranging between 1.00 and 4.00).

3. Changes in musculoskeletal pain

   Time frame: Musculoskeletal Pain will be assessed 2 months prior to the interventions and 12 months post interventions

   Self-reported intensity of pain in five anatomic sites; neck, shoulder, back, arm, and leg. Each question is phrased: "Have you been troubled by… (e.g. neck pain) the last 4 weeks? Response alternatives are: 1) "not troubled", 2) "a little troubled", 3) "rather intensely troubled" and 4)" very intensely troubled"

4. Changes in physician-certified absence from work, number of events (17 days or more) per 100 employee-years

   Time frame: The absence rate will be assessed during the one year prior to the interventions and during the one year after the interventions

   Data from the Norwegian Labour and Welfare Administration's sickness benefit register. This register provides complete registrations of all sickness absence episodes-including the length and medical diagnosis-which are compensated by the national insurance sickness benefit. As a general rule, everybody working or living in Norway is covered by the Norwegian national social insurance.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
• BackgroundM. Dallner, A.-L. Elo, F. Gamberale, V. Hottinen, S. Knardahl, K. Lindström, A. Skogstad, E. Ørhede. Validation of the General Nordic Questionnaire (QPSNordic) for psychological and social factors at work. Nordic Council of Ministers, Copenhagen (2000)
• Background: PubMed 29325179Christensen JO, Nielsen MB, Finne LB, Knardahl S. Comprehensive profiles of psychological and social work factors as predictors of site-specific and multi-site pain. Scand J Work Environ Health. 2018 May 1;44(3):291-302. doi: 10.5271/sjweh.3706. Epub 2018 Jan 11.
• Background: PubMed 30370910Andersen JH, Malmros P, Ebbehoej NE, Flachs EM, Bengtsen E, Bonde JP. Systematic literature review on the effects of occupational safety and health (OSH) interventions at the workplace. Scand J Work Environ Health. 2019 Mar 1;45(2):103-113. doi: 10.5271/sjweh.3775. Epub 2018 Oct 29.
• Background: PubMed 23996220Mischke C, Verbeek JH, Job J, Morata TC, Alvesalo-Kuusi A, Neuvonen K, Clarke S, Pedlow RI. Occupational safety and health enforcement tools for preventing occupational diseases and injuries. Cochrane Database Syst Rev. 2013 Aug 30;2013(8):CD010183. doi: 10.1002/14651858.CD010183.pub2.
• Background: PubMed 12745773Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36). Nord J Psychiatry. 2003;57(2):113-8. doi: 10.1080/08039480310000932.
• Background: PubMed 25851186Stromholm T, Pape K, Ose SO, Krokstad S, Bjorngaard JH. Psychosocial working conditions and sickness absence in a general population: a cohort study of 21,834 workers in Norway (The HUNT Study). J Occup Environ Med. 2015 Apr;57(4):386-92. doi: 10.1097/JOM.0000000000000362.
• Derived from this study: PubMed 41233599Knutsen RH, Nielsen MB, Fostervold KI, Johannessen HA. Associations between workplace aggression and subsequent mental distress and sick leave among home care workers. Int Arch Occup Environ Health. 2025 Dec;98(9-10):899-911. doi: 10.1007/s00420-025-02183-2. Epub 2025 Nov 13.
• Derived from this study: PubMed 40851813Knutsen RH, Nielsen MB, Lunde LK, Fostervold KI, Johannessen HA. Sick leave due to musculoskeletal disorders: A prospective cohort study. Int J Nurs Stud Adv. 2025 Jul 6;9:100376. doi: 10.1016/j.ijnsa.2025.100376. eCollection 2025 Dec.
• Derived from this study: PubMed 36401320Johannessen HA, Knardahl S, Emberland JS, Skare O, Finnanger Garshol B. Do regulatory tools instigate measures to prevent work-related psychosocial and ergonomic risk factors? A process evaluation of a Labour inspection authority trial in the Norwegian home-care services. BMC Res Notes. 2022 Nov 18;15(1):349. doi: 10.1186/s13104-022-06244-4.
• Derived from this study: PubMed 36167785Finnanger Garshol B, Knardahl S, Emberland JS, Skare O, Johannessen HA. Effects of the Labour Inspectorate Authority's regulatory tools on psychosocial and biomechanical work factors in Norwegian home care services: a cluster randomised controlled trial. Occup Environ Med. 2022 Dec;79(12):807-815. doi: 10.1136/oemed-2022-108470. Epub 2022 Sep 27.
• Derived from this study: PubMed 31772092Indregard AR, Knardahl S, Emberland JS, Skare O, Johannessen HA. Effectiveness of the Labour Inspection Authority's regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers. BMJ Open. 2019 Nov 26;9(11):e031226. doi: 10.1136/bmjopen-2019-031226.
• Statistics Norway, Working environment, survey on living conditionsLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary outcome measures will be made available

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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.

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