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

Not Applicable

Active, not recruiting

• Conditions: Depressive Disorder; Anxiety Disorders
• Interventions: Behavioral: Workplace convergence dialogue; Behavioral: Care Manager

• Registration Number: NCT03250026
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Study Start: 2017-12-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 349

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (Workplace dialogue)	Workplace convergence dialogue	Intervention: Work place convergence dialogue contact
Intervention (Workplace dialogue)	Care Manager	Intervention: Work place convergence dialogue contact
Care Manager	Care Manager	Intervention: Care Manager contact 12 weeks (Care as usual)

Primary Outcome Measures

Name	Time	Method
Net and gross sick-leave days	12 months	number of net and gross sick-leave days during 12 months

Secondary Outcome Measures

Name	Time	Method
Exhaustion	6 and 12 months	Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome
Quality-of-life questionnaire score	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
Work ability	6 and 12 months	Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome
Depressive symptoms	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
Anxiety symptoms	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

Trial Locations

Locations (1)

Department of Primary Health Care, Sahlgrenska Academy; 🇸🇪 Göteborg, Region Västra Götaland, Sweden