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Active, not recruitingNCT03250026CO-WORK-CAREUpdated Apr 5, 2024

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

An interventional study of Workplace convergence dialogue and Care Manager in Depressive Disorder and Anxiety Disorders, sponsored by Göteborg University. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by Göteborg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
349
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depressive Disorder
  • Anxiety Disorders

Keywords

  • primary care
  • convergence dialogue
  • sick leave
  • care manager
03

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Bipolar disorder
  • psychosis
  • addiction
  • other serious mental disorder
  • suicidal ideation or earlier suicide attempt
  • cognitive impairment or not speaking/understanding Swedish
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
349 participants (actual)

Study arms

  • Experimental
    Intervention (Workplace dialogue)

    Intervention: Work place convergence dialogue contact

    Behavioral: Workplace convergence dialogue · Behavioral: Care Manager

  • Active comparator
    Care Manager

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

    Behavioral: Care Manager

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

05

What researchers measure

Primary outcomes

  1. Net and gross sick-leave days

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

    Time frame: 12 months

Secondary outcomes

  1. Depressive symptoms

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

    Time frame: 6 and 12 months

  2. Anxiety symptoms

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

    Time frame: 6 and 12 months

  3. Quality-of-life questionnaire score

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

    Time frame: 6 and 12 months

  4. Work ability

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

    Time frame: 6 and 12 months

  5. Exhaustion

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

    Time frame: 6 and 12 months

06

Study locations

1 site
  • Department of Primary Health Care, Sahlgrenska Academy
    Göteborg, Region Västra Götaland 40530, Sweden
07

References and documents

Publications

  • 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. PubMed 33339512 ↗
  • 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. PubMed 37295824 ↗
  • 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. PubMed 35803640 ↗

Individual participant data

Plan to share: Yes — De-identified data of individual participants will be made available to other researchers, provided reasonable request by personal contact, as soon as publication of results is effected.

Supporting information: Study protocol, Icf, Csr

08

Registry details

Key details

Study ID
NCT03250026
Lead sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
Responsible party
Sponsor
First posted
Aug 15, 2017
Start date
Dec 5, 2017
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Apr 5, 2024

Study contacts

Cecilia Björkelund, prof
principal investigator · Göteborg University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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