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

NCT03250026 | Active Not Recruiting DMC

• 1 other identifier: 459-17
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Anxiety Disorders

Keywords

primary care; convergence dialogue; sick leave; care manager

Outcome Measures

Primary Outcomes (1)

• Net and gross sick-leave days

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

  12 months

Secondary Outcomes (5)

• Depressive symptoms

  6 and 12 months

• Anxiety symptoms

  6 and 12 months

• Quality-of-life questionnaire score

  6 and 12 months

• Work ability

  6 and 12 months

• Exhaustion

  6 and 12 months

Study Arms (2)

Intervention (Workplace dialogue)

EXPERIMENTAL

Intervention: Work place convergence dialogue contact

Behavioral: Workplace convergence dialogue; Behavioral: Care Manager

Care Manager

ACTIVE COMPARATOR

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

Behavioral: Care Manager

Interventions

Workplace convergence dialogue BEHAVIORAL

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

Intervention (Workplace dialogue)

Care Manager BEHAVIORAL

Regular contact Care Manager during around 12 weeks

Care Manager; Intervention (Workplace dialogue)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Department of Primary Health Care, Sahlgrenska Academy

Gothenburg, Region Västra Götaland, 40530, Sweden

Location

Related Publications (7)

• 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.

  PMID: 33339512 BACKGROUND

• 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.

  PMID: 38718100 BACKGROUND

• 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.

  PMID: 35977733 BACKGROUND

• 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.

  PMID: 35802679 BACKGROUND

• 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.

  PMID: 38555865 BACKGROUND

• 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.

  PMID: 37295824 RESULT

• 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.

  PMID: 35803640 RESULT

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders

Interventions

Case Managers

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Cecilia Björkelund, prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic randomised controlled trial; randomisation on primary care centre level

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 15, 2017
• Study Start: December 5, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available after 12 months after study completion/ alternatively as soon as publication of results is effected.
• Access Criteria: Data access will be reviewed by an external independent review panel.

Locations

SE (1)