Effects of Regulatory Tools on Work Environment and Employee Health
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
1 other identifier
interventional
2,555
1 country
130
Brief Summary
This study evaluates the effects of the Labour Inspection Authority's regulatory tools on workplace exposures to prevent employee ill health. Norwegian municipal enterprises with employees in the home care sector have been randomized to three different experimental groups and to one control group. We hypothesize a significant lower level of work environmental exposures and health complaints, after adjusting for pre-intervention measures, in the experimental groups compared to the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Typical duration for not_applicable
130 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedStudy Start
First participant enrolled
March 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2022
CompletedMay 6, 2022
May 1, 2022
1.7 years
February 15, 2019
May 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in self reported occupational exposures
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"
Self-Reported Occupational Exposures will be assessed 2 months prior to the interventions and 12 months post interventions
Changes in psychological distress HSCL-5
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).
Psychological Distress will be assessed 2 months prior to the interventions and 12 months post interventions
Changes in musculoskeletal pain
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"
Musculoskeletal Pain will be assessed 2 months prior to the interventions and 12 months post interventions
Changes in physician-certified absence from work, number of events (17 days or more) per 100 employee-years
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.
The absence rate will be assessed during the one year prior to the interventions and during the one year after the interventions
Study Arms (4)
Inspection visits
EXPERIMENTALRegulatory tool to ensure enterprise compliance with legal requirements
Guidance workshops
EXPERIMENTALRegulatory tool applied to inform and advise enterprises on legal requirements and how to realize compliance with such requirements
Online risk assessment tool
EXPERIMENTALRegulatory tool applied to aid enterprises in conducting written objectives concerning health, environment and safety activities
Control group
NO INTERVENTIONThe Labour Inspection Authority will not preform any intervention activities in enterprises assign to the control group
Interventions
Normative intervention aimed at enforcing compliance with legal occupational health and safety requirements
Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements
Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements
Eligibility Criteria
You may qualify if:
- All employees in municipal enterprises that provide home care services with a minimum of 20 employees and a maximum of 100 employees.
You may not qualify if:
- Employees in municipal enterprises that have received an inspection from the Labour Inspectorate in the years 2017 and 2018.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (130)
Hjemmetjenesten i Tysvær kommune
Tysvær, Aksdal, 5575, Norway
Hjemmetjenesten i Averøy kommune
Vebenstad, Averøy, 6530, Norway
Hjemmetjenesten i Evenes kommune
Evenes, Bogen, 8539, Norway
Hjemmetjenesten i Dønna kommune
Dønnes, Dønna, 8820, Norway
Hjemmetjenesten i Åsnes kommune
Åsnes, Flisa, 2270, Norway
Hjemmetjenesten i Luster kommune
Luster, Gaupne, 6868, Norway
Hjemmetjenesten i Nannestad kommune
Teigebyen, Nannestad, 2030, Norway
Hjemmetjenesten i Storfjord kommune
Storfjord, Oteren, 9046, Norway
Hjemmetjenesten i Åmot kommune
Åmot, Rena, 2450, Norway
Hjemmetjenesten i Rendalen kommune
Redalen, Rendalen, 2484, Norway
Hjemmetjenesten i Råde kommune
Moss, Råde, 1640, Norway
Hjemmetjenesten i Gloppen kommune
Vereide, Sandane, 6823, Norway
Hjemmetjenesten i Skjåk kommune
Skår, Skjåk, 2690, Norway
Hjemmetjenesten i Sund kommune
Sund, Skogsvåg, 5371, Norway
Hjemmetjenesten i Smøla kommune
Smørås, Smøla, 6570, Norway
Hjemmetjenesten i Stord kommune
Leirvik, Stord, 5402, Norway
Hjemmetjenesten i Trøgstad kommune
Mysen, Trøgstad, 1860, Norway
Hjemmetjenesten i Giske kommune
Ålesund, Valderøya, 6050, Norway
Hjemmetjenesten i Vang kommune
Vang, Valdres, 2975, Norway
Hjemmetjenesten i Vega kommune
Nordland, Vega, 8980, Norway
Hjemmetjenesten i Lindesnes kommune
Linnes, Vest-Agder, 4524, Norway
Hjemmetjenesten i Andøy kommune
Andenes, 8483, Norway
Hjemmetjenesten i Askvoll kommune
Askvoll, 6988, Norway
Hjemmetjenesten i Aure kommune
Aure, 6689, Norway
Hjemmetjenesten i Aurland kommune
Aurland, 1421, Norway
Hjemmetjenesten i Ål kommune
Ål, 3570, Norway
Hjemmetjenesten i Åmli kommune
Åmli, 4865, Norway
Hjemmetjenesten i Årdal kommune
Årdalstangen, 6885, Norway
Hjemmetjenesten i Ballangen kommune
Ballangen, 8540, Norway
Hjemmetjenesten i Aurskog Høland kommune
Bjørkelangen, 1940, Norway
Hjemmetjenesten i Kvæfjord kommune
Borkenes, 9475, Norway
Hjemmetjenesten i Haram kommune
Brattvåg, 6270, Norway
Hjemmetjenesten i Hasvik kommune
Breivikbotn, 9593, Norway
Hjemmetjenesten i Time kommune
Bryne, 4349, Norway
Hjemmetjenesten i Kvænangen kommune
Burfjord, 9161, Norway
Hjemmetjenesten i Bø
Bø, 3833, Norway
Hjemmetjenesten i Nordre Land kommune
Dokka, 2882, Norway
Hjemmetjenesten i Drammen kommune
Drammen, 3015, Norway
Hjemmetjenesten i Drangedal kommune
Drangedal, 3750, Norway
Hjemmetjenesten i Frogn kommune
Drøbak, 1443, Norway
Hjemmetjenesten i Eide kommune
Eide, 6490, Norway
Hjemmetjenesten i Gulen kommune
Eivindvik, 5966, Norway
Hjemmetjenesten i Elverum kommune
Elverum, 2408, Norway
Hjemmetjenesten i Skånland kommune
Evenskjer, 9439, Norway
Hjemmetjenesten i Evje og Hornnes kommune
Evje, 4735, Norway
Hjemmetjenesten i Nord-Aurdal kommune
Fagernes, 2900, Norway
Hjemmetjenesten i Fauske kommune
Fauske, 8200, Norway
Hjemmetjenesten i Fedje kommune
Fedje, 5947, Norway
Hjemmetjenesten i Flekkefjord kommune
Flekkefjord, 4400, Norway
Hjemmetjenesten i Herøy kommune
Fosnavåg, 6699, Norway
Hjemmetjenesten i Fyresdal kommune
Fyresdal, 3870, Norway
Hjemmetjenesten i Gjerstad kommune
Gjerstad, 4980, Norway
Hjemmetjenesten i Gol kommune
Gol, 3550, Norway
Hjemmetjenesten i Hareid kommune
Hareid, 6060, Norway
Hjemmetjenesten i Øvre Eiker kommune
Hokksund, 3301, Norway
Hjemmetjenesten i Søndre Land kommune
Hov, 2860, Norway
Hjemmetjenesten i Ringerike kommune
Hønefoss, 3502, Norway
Hjemmetjenesten i Iveland kommune
Iveland, 4724, Norway
Hjemmetjenesten i Ullensaker kommune
Jessheim, 2051, Norway
Hjemmetjenesten i Jevnaker kommune
Jevnaker, 3520, Norway
Hjemmetjenesten i Strand kommune
Jørpeland, 4100, Norway
Hjemmetjenesten i Grue kommune
Kirkenær, 2661, Norway
Hjemmetjenesten i Klepp kommune
Kleppe, 4352, Norway
Hjemmetjenesten i Hemnes kommune
Korgen, 8646, Norway
Hjemmetjenesten i Kragerø kommune
Kragerø, 3791, Norway
Hjemmetjenesten i Kvinesdal kommune
Kvinesdal, 4480, Norway
Hjemmetjenesten i Bamble kommune
Langesund, 3993, Norway
Hjemmetjenesten i Sande kommune Møre og Romsdal
Larsnes, 6084, Norway
Hjemmetjenesten i Leikanger kommune
Leikanger, 6863, Norway
Hjemmetjenesten i Steigen kommune
Leinesfjorden, 8283, Norway
Hjemmetjenesten i Leirfjord kommune
Leirfjord, 8890, Norway
Hjemmetjenesten i Vestvågøy kommune
Leknes, 8376, Norway
Hjemmetjenesten i Lesja kommune
Lesja, 2665, Norway
Hjemmetjenesten i Lillesand
Lillesand, 4790, Norway
Hjemmetjenesten i Osterøy kommune
Lonevåg, 5282, Norway
Hjemmetjenesten i Lærdal kommune
Lærdal, 6886, Norway
Hjemmetjenesten i Løten kommune
Løten, 2341, Norway
Hjemmetjenesten i Midsund kommune
Midsund, 6475, Norway
Hjemmetjenesten i Rana kommune
Mo i Rana, 8622, Norway
Hjemmetjenesten i Målselv kommune
Moen, 9321, Norway
Hjemmetjenesten i Vefsen kommune
Mosjøen, 8657, Norway
Hjemmetjenesten i Eidsberg kommune
Mysen, 1850, Norway
Hjemmetjenesten i Nes kommune Buskerud
Nesbyen, 3540, Norway
Hjemmetjenesten i Songdalen kommune
Nodeland, 4685, Norway
Hjemmetjenesten i Kvam kommune
Norheimsund, 5600, Norway
Hjemmetjenesten i Notodden kommune
Notodden, 3672, Norway
Hjemmetjenesten i Odda kommune
Odda, 5750, Norway
Hjemmetjenesten i Sel kommune
Otta, 2670, Norway
Hjemmetjenesten i Sigdal kommune
Prestfoss, 3350, Norway
Hjemmetjenesten i Rakkestad kommune
Rakkestad, 1891, Norway
Randaberg kommune
Randaberg, 4070, Norway
Hjemmetjenesten i Re kommune
Re, 3164, Norway
Hjemmetjenesten i Risør kommune
Risør, 4952, Norway
Hjemmetjenesten i Tinn kommune
Rjukan, 3661, Norway
Hjemmetjenesten i Kvinnherad kommune
Rosendal, 5470, Norway
Hjemmetjenesten i Lunner kommune
Røa, 2740, Norway
Hjemmetjenesten i Nore og Uvdal kommune
Rødberg, 3630, Norway
Hjemmetjenesten i Hole kommune
Røyse, 3530, Norway
Hjemmetjenesten i Nord-Odal kommune
Sagstua, 2120, Norway
Hjemmetjenesten i Suldal kommune
Sand, 4230, Norway
Hjemmetjenesten i Sauda kommune
Sauda, 4200, Norway
Hjemmetjenesten i Hjartdal kommune
Sauland, 3692, Norway
Hjemmetjenesten i Selje kommune
Selje, 6740, Norway
Hjemmetjenesten i Seljord kommune
Seljord, 3840, Norway
Hjemmetjenesten i Sør-Odal kommune
Skarnes, 2100, Norway
Hjemmetjenesten i Hvaler kommune
Skjærhalden, 1680, Norway
Hjemmetjenesten i Sola kommune
Sola, 4097, Norway
Hjemmetjenesten i Spydeberg kommune
Spydeberg, 1820, Norway
Hjemmetjenesten i Stordal kommune
Stordal, 6250, Norway
Hjemmetjenesten i Nordreisa kommune
Storslett, 9156, Norway
Hjemmetjenesten i Sørfold kommune
Straumen, 8226, Norway
Hjemmetjenesten i Bø kommune Nordland
Straumsjøen, 8475, Norway
Hjemmetjenesten i Sunndal kommune
Sunndalsøra, 6601, Norway
Hjemmetjenesten i Sveio kommune
Sveio, 5559, Norway
Hjemmetjenesten i Vågan kommune
Svolvær, 8300, Norway
Hjemmetjenesten i Sykkylven kommune
Sykkylven, 6230, Norway
Hjemmetjenesten i Sørreisa kommune
Sørreisa, 9310, Norway
Hjemmetjenesten i Tvedestrand kommune
Tvedestrand, 4901, Norway
Hjemmetjenesten i Tynset kommune
Tynset, 2500, Norway
Hjemmetjenesten i Samnanger kommune
Tysse, 5660, Norway
Hjemmetjenesten i Tysnes kommune
Uggdal, 5686, Norway
Hjemmetjenesten i Vennesla kommune
Vennesla, 4701, Norway
Hjemmetjenesten i Vinje kommune
Vinje, 3890, Norway
Hjemmetjenesten i Nord-Fron kommune
Vinstra, 2640, Norway
Hjemmetjenesten i Volda kommune
Volda, 6100, Norway
Hjemmetjenesten i Vindafjord kommune
Ølen, 5580, Norway
Hjemmetjenesten i Marker kommune
Ørje, 1870, Norway
Hjemmetjenesten i Meløy kommune
Ørnes, 8150, Norway
Hjemmetjenesten i Gausdal kommune
Østre Gausdal, 2651, Norway
Hjemmetjenesten i Øyer kommune
Øyer, 2636, Norway
Related Publications (10)
M. 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)
BACKGROUNDChristensen 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.
PMID: 29325179BACKGROUNDAndersen 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.
PMID: 30370910BACKGROUNDMischke 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.
PMID: 23996220BACKGROUNDStrand 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.
PMID: 12745773BACKGROUNDStromholm 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.
PMID: 25851186BACKGROUNDKnutsen 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.
PMID: 40851813DERIVEDJohannessen 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.
PMID: 36401320DERIVEDFinnanger 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.
PMID: 36167785DERIVEDIndregard 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.
PMID: 31772092DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Håkon A Johannessen, PhD
National Institute of Occupational Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- the study group assignment is kept hidden from the data-analysts and manuscript writers after allocation
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2019
First Posted
February 26, 2019
Study Start
March 5, 2019
Primary Completion
November 30, 2020
Study Completion
February 25, 2022
Last Updated
May 6, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available 3 years after study completion
- Access Criteria
- Data access request will be reviewed by NSD - Norwegian Centre for Research Data
De-identified individual participant data for all primary outcome measures will be made available