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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03250026
Acronym
CO-WORK-CARE
Enrollment
349
Registered
2017-08-15
Start date
2017-12-05
Completion date
2027-12-31
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Depressive Disorder

Keywords

primary care, convergence dialogue, sick leave, care manager

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.

Interventions

BEHAVIORALWorkplace convergence dialogue

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

BEHAVIORALCare Manager

Regular contact Care Manager during around 12 weeks

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pragmatic randomised controlled trial; randomisation on primary care centre level

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Net and gross sick-leave days12 monthsnumber of net and gross sick-leave days during 12 months

Secondary

MeasureTime frameDescription
Depressive symptoms6 and 12 monthsChange of depressive symptoms Montgomery-Asberg Depression Rating Scale - Self rating version (MADRS-S) Range 0-60 (Total score) Low score better outcome
Anxiety symptoms6 and 12 monthsChange of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome
Quality-of-life questionnaire score6 and 12 monthsChange of quality of life EuroQoL-5 Dimension Questionnaire(EQ-5D) Range 0-1.0(total score) low score worst outcome
Work ability6 and 12 monthsChange of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome
Exhaustion6 and 12 monthsChange of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026