Health in Work - a Measure for Increased Coping and Work Inclusion

NCT04000035 | Active Not Recruiting

• 1 other identifier: 2018/2262(REK)
• Study Type: interventional
• Target: 1,383
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Musculoskeletal Pain; Mental Health Wellness 1; Work-Related Condition

Keywords

sickness absence; psychosocial work environment

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  Time period 24 months prior to randomization through 24 months after randomization

Secondary Outcomes (8)

• Change in physician-certified sickness absence rates (individual level)

  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)

  Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization

• Change in psychosocial work environment by Demand-Control-Support-Questionnaire score

  Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization

• Change in social support from colleagues by NDSS-16 score

  Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization

• Change in job satisfaction by GJS score

  Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization

Study Arms (2)

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.

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.

Other: Health and work environment information and processes

Interventions

Health and work environment information and processes OTHER

see arm/group description

Health in work; Regular work place measures

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• minimum 8 employees
• all staff employed \> 20% in the participating workplaces/workplace units
• Norwegian-speaking

You may not qualify if:

• \- ongoing profound reorganisation at the workplace/workplace unit (\>20% change of employees within workplace unit)
• \- none

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator
• Norwegian Labour and Welfare Administration: collaborator
• Helse Nord: collaborator

Study Sites (1)

University Hospital of Nothern Norway

Tromsø, Norway

Location

Related Publications (2)

• 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.

  PMID: 35388792 BACKGROUND

• 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.

  PMID: 40730635 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Health

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Nils Fleten, Phd

  UiT The artic University of Norway / Norwegian Welfare Service Troms

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: two groups: intervention and control

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 27, 2019
• Study Start: June 14, 2019
• Primary Completion: July 1, 2023
• Study Completion (Estimated): July 1, 2035
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

NO (1)