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

NCT ID: NCT03250026

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

349 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Depressive Disorder Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic randomised controlled trial; randomisation on primary care centre level
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention (Workplace dialogue)

Intervention: Work place convergence dialogue contact

Group Type EXPERIMENTAL

Workplace convergence dialogue

Intervention Type BEHAVIORAL

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

Care Manager

Intervention Type BEHAVIORAL

Regular contact Care Manager during around 12 weeks

Care Manager

Intervention: Care Manager contact 12 weeks (Care as usual)

Group Type ACTIVE_COMPARATOR

Care Manager

Intervention Type BEHAVIORAL

Regular contact Care Manager during around 12 weeks

Interventions

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Workplace convergence dialogue

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

Intervention Type BEHAVIORAL

Care Manager

Regular contact Care Manager during around 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cecilia Björkelund, prof

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Department of Primary Health Care, Sahlgrenska Academy

Gothenburg, Region Västra Götaland, Sweden

Site Status

Countries

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Sweden

References

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Petersson EL, Tornbom K, Hange D, Nejati S, Jerlock M, Wikberg C, Bjorkelund C, Svenningsson I. The experiences of care managers and rehabilitation coordinators of a primary care intervention to promote return to work for patients with common mental disorders: a qualitative study. BMC Fam Pract. 2020 Dec 18;21(1):272. doi: 10.1186/s12875-020-01348-x.

Reference Type BACKGROUND
PMID: 33339512 (View on PubMed)

Petersson EL, Tornbom K, Bjorkelund C, Jerlock M, Hange D, Udo C, Svenningsson I. Process evaluation of the CO-WORK-CARE model: Collaboration and a person-centred dialogue meeting for patients with common mental disorder in primary health care. Scand J Caring Sci. 2024 Sep;38(3):602-613. doi: 10.1111/scs.13268. Epub 2024 May 8.

Reference Type BACKGROUND
PMID: 38718100 (View on PubMed)

Saxvik A, Svenningsson I, Tornbom K, Petersson EL, Bjorkelund C, Gabartaite G, Hange D. GPs' experiences of a collaborative care model for patients with common mental disorders who need sick leave certification: a qualitative study. BJGP Open. 2022 Dec 20;6(4):BJGPO.2022.0042. doi: 10.3399/BJGPO.2022.0042. Print 2022 Dec.

Reference Type BACKGROUND
PMID: 35977733 (View on PubMed)

Saxvik A, Tornbom K, Petersson EL, Hange D, Nejati S, Bjorkelund C, Svenningsson I. Experiences of patients with common mental disorders concerning team-based primary care and a person-centered dialogue meeting: An intervention to promote return to work. PLoS One. 2022 Jul 8;17(7):e0271180. doi: 10.1371/journal.pone.0271180. eCollection 2022.

Reference Type BACKGROUND
PMID: 35802679 (View on PubMed)

Bjorkelund C, Petersson EL, Svenningsson I, Saxvik A, Wiegner L, Hensing G, Jonsdottir IH, Larsson M, Wikberg C, Ariai N, Nejati S, Hange D. Effects of adding early cooperation and a work-place dialogue meeting to primary care management for sick-listed patients with stress-related disorders: CO-WORK-CARE-Stress - a pragmatic cluster randomised controlled trial. Scand J Prim Health Care. 2024 Sep;42(3):378-392. doi: 10.1080/02813432.2024.2329212. Epub 2024 Mar 31.

Reference Type BACKGROUND
PMID: 38555865 (View on PubMed)

Bjorkelund C, Saxvik A, Svenningsson I, Petersson EL, Wiegner L, Larsson M, Tornbom K, Wikberg C, Ariai N, Nejati S, Hensing G, Hange D. Rehabilitation cooperation and person-centred dialogue meeting for patients sick-listed for common mental disorders: 12 months follow-up of sick leave days, symptoms of depression, anxiety, stress and work ability - a pragmatic cluster randomised controlled trial from the CO-WORK-CARE project. BMJ Open. 2023 Jun 9;13(6):e074137. doi: 10.1136/bmjopen-2023-074137.

Reference Type RESULT
PMID: 37295824 (View on PubMed)

Svenningsson I, Bjorkelund C, Hange D, Wiegner L, Ariai N, Petersson EL. Symptom patterns in patients newly sick listed for common mental disorders and associations with work-related and socioeconomic factors: a cross-sectional study in Swedish primary care. BMJ Open. 2022 Jul 8;12(7):e054250. doi: 10.1136/bmjopen-2021-054250.

Reference Type RESULT
PMID: 35803640 (View on PubMed)

Other Identifiers

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459-17

Identifier Type: -

Identifier Source: org_study_id

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