Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE (CO-WORK-CARE)
Primary Purpose
Depressive Disorder, Anxiety Disorders
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Workplace convergence dialogue
Care Manager
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring primary care, convergence dialogue, sick leave, care manager
Eligibility Criteria
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
Sites / Locations
- Department of Primary Health Care, Sahlgrenska Academy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention (Workplace dialogue)
Care Manager
Arm Description
Intervention: Work place convergence dialogue contact
Intervention: Care Manager contact 12 weeks (Care as usual)
Outcomes
Primary Outcome Measures
Net and gross sick-leave days
number of net and gross sick-leave days during 12 months
Secondary Outcome Measures
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
Anxiety symptoms
Change of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome
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
Work ability
Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome
Exhaustion
Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome
Full Information
NCT ID
NCT03250026
First Posted
August 9, 2017
Last Updated
September 15, 2023
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT03250026
Brief Title
Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Anxiety Disorders
Keywords
primary care, convergence dialogue, sick leave, care manager
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic randomised controlled trial; randomisation on primary care centre level
Masking
None (Open Label)
Allocation
Randomized
Enrollment
349 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (Workplace dialogue)
Arm Type
Experimental
Arm Description
Intervention: Work place convergence dialogue contact
Arm Title
Care Manager
Arm Type
Active Comparator
Arm Description
Intervention: Care Manager contact 12 weeks (Care as usual)
Intervention Type
Behavioral
Intervention Name(s)
Workplace convergence dialogue
Intervention Description
Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide
Intervention Type
Behavioral
Intervention Name(s)
Care Manager
Intervention Description
Regular contact Care Manager during around 12 weeks
Primary Outcome Measure Information:
Title
Net and gross sick-leave days
Description
number of net and gross sick-leave days during 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
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
Title
Anxiety symptoms
Description
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
Title
Quality-of-life questionnaire score
Description
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
Title
Work ability
Description
Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome
Time Frame
6 and 12 months
Title
Exhaustion
Description
Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Björkelund, prof
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Primary Health Care, Sahlgrenska Academy
City
Göteborg
State/Province
Region Västra Götaland
ZIP/Postal Code
40530
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available after 12 months after study completion/ alternatively as soon as publication of results is effected.
IPD Sharing Access Criteria
Data access will be reviewed by an external independent review panel.
Citations:
PubMed Identifier
37295824
Citation
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.
Results Reference
result
PubMed Identifier
35803640
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 care. BMJ Open. 2022 Jul 8;12(7):e054250. doi: 10.1136/bmjopen-2021-054250.
Results Reference
result
PubMed Identifier
33339512
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.
Results Reference
derived
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Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE
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