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Care Manager - Coordinating Care for Person Centered Management of Depression in Primary Care (PRIM-CARE)

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ClinicalTrials.gov Identifier: NCT02378272
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Göteborg University

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.


Condition or disease Intervention/treatment Phase
Depression Other: care manager for depression Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RCT on Care Manager Organization for Management of Mild-moderate Depression in the Primary Care Setting, Sweden
Study Start Date : December 2014
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Care manager for depression
A 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
Other: care manager for depression
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.

No Intervention: Treatment As Usual
Management of recruited patients with depression continued as usually applied at PCC



Primary Outcome Measures :
  1. Change of level of depression (Self-reported level of depressive symptoms measured by Beck Depression Inventory II) [ Time Frame: 0- 6 months ]
    Self-reported level of depressive symptoms measured by Beck Depression Inventory II


Secondary Outcome Measures :
  1. Sick-listing (Amount of sick-listing days during 0-6 months observation period) [ Time Frame: 6 months ]
    Amount of sick-listing days during 0-6 months observation period

  2. Change of level of job strain (Perception of job strain measured by Karasek Job Strain Model) [ Time Frame: 0-6 months ]
    Perception of job strain measured by Karasek Job Strain Model

  3. Change of level of Quality of Life (Self-reported level of perceived Quality of Life measured by EQ-5D) [ Time Frame: 0- 6 months ]
    Self-reported level of perceived Quality of Life measured by EQ-5D

  4. Change of level of Work Ability (Self-reported level of perceived work ability measured by Work Ability Index) [ Time Frame: 0 - 6 months ]
    Self-reported level of perceived work ability measured by Work Ability Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed mild-moderate depression,
  • 18 years an up,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378272


Locations
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Sweden
Department of Primary Health Care, Sahlgrenska Academy
Gothenburg, Region Västra Götaland, Sweden, 40530
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Cecilia Björkelund Göteborg University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02378272     History of Changes
Other Study ID Numbers: RS 1938-2013
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Keywords provided by Göteborg University:
Care Manager
Primary Care
Depressive symptoms
quality of life
return to work
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders