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

September 18, 2023 updated by: Göteborg University

RCT on Care Manager Organization for Management of Mild-moderate Depression in the Primary Care Setting, Sweden

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods The research questions will be tested in a randomised controlled trial with follow ups 3 and 6 months in the primary care setting in cooperation between universities of Gothenburg, Karolinska Institute and primary care centres (PCC) of regions/county councils of Västra Götaland, and Dalarna.

Design A cluster randomized controlled trial of two groups (intervention and control). Randomization will be at the level of the primary care centers (PCCs).

Population of study Patients aged 18 and up that visit one of 20 different urban and rural PCCs.

Randomization All PCCs in the participating regions without employed onsite mental health professionals are invited to participate in the study. Around twenty practices will be matched into 10 blocks by depression treatment practices, thereafter 1 practice from each block will be randomly assigned to receive the care manager intervention program.

Intervention At the intervention practices, a district nurse will apply around 15-25% of working time as care coordinator for management of care for the patients with depression. Before patient recruitment begins, physicians and the nurse/district nurse (care manager) will participate in sessions for training in providing clinical services (patient information and education on patient's preferred treatment, assessment of patient's depressive symptoms and regular telephone contacts, follow up visits etc).

Recruitment of patients and Data collection Patients aged 18 and up that visit primary health care centres and are diagnosed by the General Practitioner (GP) with light/medium depression disorder according to PRIME-MD (4). The patients will be monitored up to 6 months after inclusion in the study by an individual interview (first visit, 3 and 6 months).

All parameters will be assessed at baseline and 3 and 6 months; prescription of antidepressants, number of days of labour lost, socio-demographic and economic variables, alcohol consumption, physical activity, and ethnicity. BDI-II, EuroQoL-5D, Work Ability Instrument (WAI) Karasek Job strain Model , medication, other treatment (psychological, counselling, or other).

For somatic health reasons, also blood pressure and p-glucose will be monitored, and blood samples for bio-bank storage.

Outcome criteria Change in: depression symptoms (BDI-II), work ability index (WAI), Job strain (Karasek), EQ-5D, QALYs from baseline to 3 and 6 months. Amount of sick listing (days, %), days of labour lost.

Statistical analysis Analysis of covariance, controlling for baseline value, will be used to estimate the overall treatment effectiveness (difference in score) at final follow-up. Subgroup analysis by gender as well as age adjustments will also be performed.

Power calculation The primary variable is the level of depression (as measured by the BDI-II) and analyzed in an ANCOVA model with repeated measures. In order to detect an effect of 3 units in the difference between the two groups, with a power of 80% and a significance level of 10% (two-sided) about 200 patients is needed in each group (9). The underlying assumption is a standard deviation in the group of 10 units, a within-subject correlation of 0.4, and a within-cluster-correlation of 0.1, i.e. a design effect of 1.9 to correct for having a cluster analysis.

Cost-effectiveness analysis A cost- effectiveness analysis (CEA) with quality-adjusted life years (QALY) as measure of effect will be performed.

The region Västra Götaland has proclaimed interest in the study, and financially supports the study.

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Region Västra Götaland
      • Gothenburg, Region Västra Götaland, Sweden, 40530
        • Department of Primary Health Care, Sahlgrenska Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0- 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
0-6 months
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
0- 6 months
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
0 - 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Cecilia Björkelund, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimated)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS 1938-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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