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Active, Not Recruiting

NCT Number: NCT03250026

Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE

This study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with a Care Manager during the period of sick leave. The study will be performed as a randomised controlled trial with randomisation at the PCC level where intervention PCCs offers a convergence dialogue meeting with the work place representative during sick leave in addition to Care Manager contact.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Primary Health Care, Sahlgrenska Academy

Gothenburg, Region Västra Götaland, 40530, Sweden

About this study

In Sweden sick leave time and frequency are increasing. This is primarily in the area of common mental disorders (CMD), and CMD is now the most common single cause of sickness absence. Primary care is the area in which most individuals with mental illness seek care and also receive care. A Care Manager function at the primary care centre (PCC) where the Care Manager is responsible for the support and close contact with patients with CMD and act as the "spider in the web" and combine patient support with other measures, have been shown to have beneficial effects for depression course. In Region Västra Götaland an implementation of the Care Manager function at the PCC has been set out, and the function is now available in nearly 100 PCCs in the region. The present study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the PCCs Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with the Care Manager during the period of sick leave. The study will be performed as pragmatic randomised controlled trial with randomisation at the PCC level. Around 20 PCCs with a Care Manager function for patients on sick-leave with CMD diagnosis will be recruited and randomized to intervention where patients in addition to a Care Manager contact (12 weeks) will have one convergence dialogue meeting with the work place representative during sick leave. Control PCCs will give Care Manager contact 12 weeks only.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients attending primary care centers with care manager function

  • aged >=18 to 67 years
  • diagnosed with a new (< 1 month) depression diagnose (F32, F33), anxiety syndrome (F41, F48) or stress related adjustment disorder (F43)
  • on sick-leave > 14 days

Exclusion criteria

  • Bipolar disorder
  • psychosis
  • addiction
  • other serious mental disorder
  • suicidal ideation or earlier suicide attempt
  • cognitive impairment or not speaking/understanding Swedish

Treatment and study plan

Workplace convergence dialogue

Behavioral

Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide

Care Manager

Behavioral

Regular contact Care Manager during around 12 weeks

Primary outcomes

  1. Net and gross sick-leave days

    Time frame: 12 months

    number of net and gross sick-leave days during 12 months

Secondary outcomes

  1. Depressive symptoms

    Time frame: 6 and 12 months

    Change of depressive symptoms Montgomery-Asberg Depression Rating Scale - Self rating version (MADRS-S) Range 0-60 (Total score) Low score better outcome

  2. Anxiety symptoms

    Time frame: 6 and 12 months

    Change of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome

  3. Quality-of-life questionnaire score

    Time frame: 6 and 12 months

    Change of quality of life EuroQoL-5 Dimension Questionnaire(EQ-5D) Range 0-1.0(total score) low score worst outcome

  4. Work ability

    Time frame: 6 and 12 months

    Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome

  5. Exhaustion

    Time frame: 6 and 12 months

    Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

Cooperation for Patients With Common Mental Disorders: Care Manager Function at the Primary Care Centre and Intervention at the Workplace - CO-WORK-CARE

Acronym: CO-WORK-CARE

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Aug 15, 2017
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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