Depression Clinical Trial
— PRIM-CAREOfficial title:
RCT on Care Manager Organization for Management of Mild-moderate Depression in the Primary Care Setting, Sweden
Verified date | September 2023 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 376 |
Est. completion date | December 31, 2018 |
Est. primary completion date | January 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - diagnosed mild-moderate depression, - 18 - 80 years, - attending primary care center Exclusion Criteria: - schizophrenia, - abuse/addiction, - psychosis, - bipolar syndrome, - suicidal ideation or earlier suicide attempt, - ongoing deep depression, - generalized anxiety syndrome, - not communicable in Swedish |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Primary Health Care, Sahlgrenska Academy | Gothenburg | Region Västra Götaland |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
Af 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 d — View Citation
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 — View Citation
Holst 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 — View Citation
Holst 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 prag — View Citation
Petersson 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Sick-listing (Amount of sick-listing days during 0-6 months observation period) | Amount of sick-listing days during 0-6 months observation period | 6 months | |
Secondary | Change of level of job strain (Perception of job strain measured by Karasek Job Strain Model) | Perception of job strain measured by Karasek Job Strain Model | 0-6 months | |
Secondary | Change of level of Quality of Life (Self-reported level of perceived Quality of Life measured by EQ-5D) | Self-reported level of perceived Quality of Life measured by EQ-5D | 0- 6 months | |
Secondary | Change of level of Work Ability (Self-reported level of perceived work ability measured by Work Ability Index) | Self-reported level of perceived work ability measured by Work Ability Index | 0 - 6 months |
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