Early Identification of Persons at Risk for Sick-leave Due to Work-related Stress (TIDAS)

November 2, 2018 updated by: Göteborg University

Early Identification of People at Risk for Sick-leave Due to Work-related Stress - A Randomized Controlled Study of People With Mental Disorders and Physical Complaints Consulting Primary Health Care

A vital question for society in general and primary health care in particular is early identification of persons at risk of sickness absence due to work-related stress. Even though both the individual and society can gain a lot from the prevention of absence, not the least since return to work is costly once a person is sick-listed. There is, surprisingly enough, no established method to do this. This project is a randomized controlled study of people with mental disorders and physical complaints consulting primary care. The purpose is to evaluate if a systematic use of early identification of work-related stress, combined with feedback at consultation, at the primary health care centers can prevent sickness absence among employed women and men with common mental disorders and subjective physical health complaints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is no method or established practice in primary health care when it comes to the important issue of early identification of people at risk of sickness absence due to work-related stress. But work-related stress is common and can cause ill-health and sick-listing. Therefore it is a vital question for society in general and primary health care in particular finding methods to early identify persons at such risk. Both the individual and society can gain a lot from the prevention of absence, not the least since return to work is costly once a person is sick-listed.

Both women and men see a doctor due to the symptoms, and a majority often goes to the primary health care, and this long before sick-listing comes into question. It could very well be that neither patient, nor doctor is aware that the symptoms the patient describes are caused by work and the stress the patient is subject to there. There is, though, a questionnaire, the Work Stress Questionnaire (WSQ), that has been developed to early identify people at risk.

The purpose of this randomized controlled trial is to evaluate if systematic use of the WSQ can reduce the number of sick-days twelve months on in women and men consulting a primary health care GP due to physical and mental complaints. The intervention consists of giving the GPs the WSQ as a tool for systematic use to early identify people at risk, and then be able to refer the patients to preventive health care and other measures within the primary health care or the patient's occupational health service.

The project will be carried out within the Region Västra Götaland and engage around 40 general practitioners, who will in all recruit 420 participants (210 to intervention group and 210 to control group). A register follow-up on sick-leave, healthcare treatment and the use of medicines will be made 12 months later. Three studies are planned to evaluate the intervention. Yet another study, a focus group study, is planned to make process evaluation of how the participating health care center staff perceive systematic use of the WSQ.

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Employed women and men, aged 18 - 64 years
  • Seeking care for:
  • depression
  • anxiety
  • musculoskeletal disorders
  • gastrointestinal and cardio-vascular symptoms
  • other stress-related symptoms

Exclusion Criteria:

  • Currently on sick-leave or have been on sick-leave with doctor's certificate the last month
  • Have been absent from work due to illness more than 7 days the last month (without doctor's certificate)
  • On sickness or activity payments
  • Pregnant women
  • Patients seeking care for:
  • allergy
  • diabetes
  • urinary tract infection
  • infections (whooping cough, tonsillitis)
  • COPD
  • fractures
  • lumps and spots
  • psychiatric diagnoses such as schizophrenia, other psychoses or bipolar diagnoses
  • prolonging of sick-leave certificate
  • check up of chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Questionnaire and feedback
Patients that will see a doctor randomized to the intervention group will fill in the Work Stress Questionnaire prior to the visit. The doctor gets the results from the questionnaire and then gives consultation to the patient based on the results.
Other: Questionnaire and feedback
No Intervention: Control group
Patients that will see a doctor randomized to the control group get the usual treatment/consultation and after the visit fill in the Work Stress Questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sick-leave days.
Time Frame: 12 months after inclusion
Differences in number of sick-leave days between intervention group and control group.
12 months after inclusion
Number of periods of sick-leave, full-time or part-time.
Time Frame: 12 months after inclusion
Differences in number of sick-leave periods, full-time or part-time between intervention group and control group.
12 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of health care treatments.
Time Frame: 12 months after inclusion
Differences in healthcare treatment between the intervention group and the control group.
12 months after inclusion
Types of health care treatments.
Time Frame: 12 months after inclusion
Differences in healthcare treatment between the intervention group and the control group.
12 months after inclusion
Number of medicines prescriptions.
Time Frame: 12 months after inclusion
Differences in the use of medicines between the intervention group and the control group.
12 months after inclusion
Types of medicines prescriptions.
Time Frame: 12 months after inclusion
Differences in the use of medicines between the intervention group and the control group.
12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Vastra Gotaland Region

Investigators

  • Principal Investigator: Kristina Holmgren, Docent, Section for Rehabilitation and Health, Inst for neuro science and physiology, Sahlgrenska academy, University of Gothenburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 2, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIDAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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