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

Anxiety Disorders Clinical Trial

— CO-WORK-CARE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03250026
• Other study ID #: 459-17
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 349
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder

Intervention

Behavioral:
• Workplace convergence dialogue
Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide
• Care Manager
Regular contact Care Manager during around 12 weeks

Locations

Country	Name	City	State
Sweden	Department of Primary Health Care, Sahlgrenska Academy	Göteborg	Region Västra Götaland

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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: 1 — View Citation

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. — View Citation

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 ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net and gross sick-leave days	number of net and gross sick-leave days during 12 months	12 months
Secondary	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	6 and 12 months
Secondary	Anxiety symptoms	Change of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome	6 and 12 months
Secondary	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	6 and 12 months
Secondary	Work ability	Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome	6 and 12 months
Secondary	Exhaustion	Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome	6 and 12 months