Collaborative Care for Depressed Elderly in Korea

March 10, 2016 updated by: Hyeon Woo Yim, National Clinical Research Coordination Center, Seoul, Korea
Late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management intervention, and examine its effectiveness on the depressive symptoms of older patients in Korean primary care settings. Based on chronic disease management theory and previous Collaborative care management studies in western countries, we propose to test a Depression Care Management intervention,which includes care manager to support a primary care physician of depression in their old patients. Care manager'd role are monitoring the progress of treatment, supporting patient's adherence, educating patients/ family and facilitate communication between providers. Also psychiatrists provide consultation and supervision of care managers. Using a randomized controlled design, we will examine whether the Depression care management is an effective treatment for patients with late life depression in rural Korea. The primary outcome would be the improvement of depressive symptoms of patients in primary care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

  • Korea, Republic of
    • ChoongBuk
      • Chungju, ChoongBuk, Korea, Republic of, 123456
        • Chungju community health care center

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 60 year or older
  • diagnosed depression based on DSM-IV criteria

Exclusion Criteria:

  • impairment of hearing
  • dementia
  • other psychiatric disorders

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
usual care
Experimental: case management
patients who assigned to the intervention group will take 7 times phone calls from case manager
Other: care management
patients who assigned to the intervention group will take 7 times phone calls from case manager

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced depression symptoms
Time Frame: 3 months
HAMD (Hamilton Depression Ratind Scale) Difference HAMD score between the intervention and control group from baseline to 3 month follow-up
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression response and remissionhealth related quality of life
Time Frame: 3months and 6months

HAMD (Hamilton Depression Ratind Scale) Depression response is defined by improvement 50% or more HAMD scores from baseline to each follow-up periods.

Depression remission is defined by 7 or less of HAMD score at each follow-up periods
3months and 6months
Reduced suicide ideation
Time Frame: 3 months and 6 months
SSI (Beck's suicide ieation scale) Difference total SSI scores Between the two groups from baseline to each follow-up periods
3 months and 6 months
Improvement of Quality of life
Time Frame: 3 months and 6 months
EQ5D Difference EQ5D scores Between the two groups from baseline to each follow-up periods
3 months and 6 months

Collaborators and Investigators

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

Sponsor

National Clinical Research Coordination Center, Seoul, Korea

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

June 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A102065_2012_1

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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