Care Manager - Coordinating Care for Person Centered Management of Depression in Primary Care
PRIM-CARE
RCT on Care Manager Organization for Management of Mild-moderate Depression in the Primary Care Setting, Sweden
1 other identifier
interventional
376
1 country
1
Brief Summary
The aim of the project is to explore if a complementary addition of a care manager for depression treatment in the primary care setting has positive effects concerning reduction of the patients' depressive symptoms as well as improvement of daily function and quality of life in a short- and long-term perspective compared with the traditional Swedish primary care organization. The aim is also to evaluate the care manager function in a health economic perspective. The specific aims are to develop and evaluate an evidence-based care manager program for patients with mild to moderate depression and to compare the evidence-based care manager program to treatment as usual (TAU) in terms of their short- and long-term effects on symptom remission, treatment adherence, care satisfaction, and self-efficacy as well as to perform a cost - effectiveness analysis of the care manager program, i.e. to evaluate the effects of the program on patients' health in relation to the running costs of the program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Dec 2014
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedSeptember 21, 2023
September 1, 2023
2.2 years
February 2, 2015
September 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II)
Self-reported level of depressive symptoms measured by Beck Depression Inventory II
0- 6 months
Secondary Outcomes (4)
Sick-listing (Amount of sick-listing days during 0-6 months observation period)
6 months
Change of level of job strain (Perception of job strain measured by Karasek Job Strain Model)
0-6 months
Change of level of Quality of Life (Self-reported level of perceived Quality of Life measured by EQ-5D)
0- 6 months
Change of level of Work Ability (Self-reported level of perceived work ability measured by Work Ability Index)
0 - 6 months
Study Arms (2)
Care manager for depression
EXPERIMENTALA district nurse will apply around 15-25% of working time as care coordinator (care manager for depression) at PCC for management of care for all recruited patients with depression
Treatment As Usual
NO INTERVENTIONManagement of recruited patients with depression continued as usually applied at PCC
Interventions
District nurse (care manager for depression) providing clinical services ( in cooperation with GP) as patient information and education on patient's preferred treatment, development of care plan, assessment of patient's depressive symptoms and regular telephone contacts.
Eligibility Criteria
You may qualify if:
- diagnosed mild-moderate depression,
- years,
- attending primary care center
You may not qualify if:
- schizophrenia,
- abuse/addiction,
- psychosis,
- bipolar syndrome,
- suicidal ideation or earlier suicide attempt,
- ongoing deep depression,
- generalized anxiety syndrome,
- not communicable in Swedish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Primary Health Care, Sahlgrenska Academy
Gothenburg, Region Västra Götaland, 40530, Sweden
Related Publications (8)
Bjorkelund C, Svenningsson I, Hange D, Udo C, Petersson EL, Ariai N, Nejati S, Wessman C, Wikberg C, Andre M, Wallin L, Westman J. Clinical effectiveness of care managers in collaborative care for patients with depression in Swedish primary health care: a pragmatic cluster randomized controlled trial. BMC Fam Pract. 2018 Feb 9;19(1):28. doi: 10.1186/s12875-018-0711-z.
PMID: 29426288RESULTHolst A, Ginter A, Bjorkelund C, Hange D, Petersson EL, Svenningsson I, Westman J, Andre M, Wikberg C, Wallin L, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: economic evaluation of a pragmatic randomised controlled study. BMJ Open. 2018 Nov 12;8(11):e024741. doi: 10.1136/bmjopen-2018-024741.
PMID: 30420353RESULTPetersson EL, Hange D, Udo C, Bjorkelund C, Svenningsson I. Long-term effect of a care manager on work ability for patients with depression - the PRIM-CARE RCT. Work. 2022;72(2):601-609. doi: 10.3233/WOR-205272.
PMID: 35527596RESULTHolst A, Labori F, Bjorkelund C, Hange D, Svenningsson I, Petersson EL, Westman J, Moller C, Svensson M. Cost-effectiveness of a care manager collaborative care programme for patients with depression in primary care: 12-month economic evaluation of a pragmatic randomised controlled trial. Cost Eff Resour Alloc. 2021 Aug 17;19(1):52. doi: 10.1186/s12962-021-00304-5.
PMID: 34404426RESULTAf Winklerfelt Hammarberg S, Bjorkelund C, Nejati S, Magnil M, Hange D, Svenningsson I, Petersson EL, Andre M, Udo C, Ariai N, Wallin L, Wikberg C, Westman J. Clinical effectiveness of care managers in collaborative primary health care for patients with depression: 12- and 24-month follow-up of a pragmatic cluster randomized controlled trial. BMC Prim Care. 2022 Aug 9;23(1):198. doi: 10.1186/s12875-022-01803-x.
PMID: 35945493RESULTAugustsson P, Petersson EL, Bjorkelund C, Persson Kylen S, Wikberg C. Organisational and social work-environment experiences after care manager implementation: a repeated cross-sectional study in Swedish primary care. Scand J Prim Health Care. 2025 Jul 28:1-12. doi: 10.1080/02813432.2025.2538486. Online ahead of print.
PMID: 40726123DERIVEDSvenningsson I, Hange D, Udo C, Tornbom K, Bjorkelund C, Petersson EL. The care manager meeting the patients' unique needs using the care manager model-A qualitative study of experienced care managers. BMC Fam Pract. 2021 Sep 3;22(1):175. doi: 10.1186/s12875-021-01523-8.
PMID: 34474682DERIVEDSvenningsson I, Petersson EL, Udo C, Westman J, Bjorkelund C, Wallin L. Process evaluation of a cluster randomised intervention in Swedish primary care: using care managers in collaborative care to improve care quality for patients with depression. BMC Fam Pract. 2019 Jul 27;20(1):108. doi: 10.1186/s12875-019-0998-4.
PMID: 31351444DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilia Björkelund
Göteborg University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
March 4, 2015
Study Start
December 1, 2014
Primary Completion
January 31, 2017
Study Completion
December 31, 2018
Last Updated
September 21, 2023
Record last verified: 2023-09