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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480855
First Posted: June 25, 2015
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University
  Purpose
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.

Condition Intervention
Occupation-related Stress Disorder Other: Questionnaire and feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Number of sick-leave days. [ Time Frame: 12 months after inclusion ]
    Differences in number of sick-leave days between intervention group and control group.

  • 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.


Secondary Outcome Measures:
  • Number of health care treatments. [ Time Frame: 12 months after inclusion ]
    Differences in healthcare treatment between the intervention group and the control group.

  • Types of health care treatments. [ Time Frame: 12 months after inclusion ]
    Differences in healthcare treatment between the intervention group and the control group.

  • Number of medicines prescriptions. [ Time Frame: 12 months after inclusion ]
    Differences in the use of medicines between the intervention group and the control group.

  • Types of medicines prescriptions. [ Time Frame: 12 months after inclusion ]
    Differences in the use of medicines between the intervention group and the control group.


Estimated Enrollment: 420
Study Start Date: June 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480855


Sponsors and Collaborators
Göteborg University
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02480855     History of Changes
Other Study ID Numbers: TIDAS
First Submitted: May 20, 2015
First Posted: June 25, 2015
Last Update Posted: February 2, 2017
Last Verified: February 2017

Keywords provided by Göteborg University:
work related stress
questionnaire
early identification