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Collaborative Care for Depressed Elderly in Korea

Primary Purpose

Depression, Elderly, Korean

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
care management
Sponsored by
National Clinical Research Coordination Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • impairment of hearing
  • dementia
  • other psychiatric disorders

Sites / Locations

  • Chungju community health care center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

case management

control

Arm Description

patients who assigned to the intervention group will take 7 times phone calls from case manager

usual care

Outcomes

Primary Outcome Measures

Reduced depression symptoms
HAMD (Hamilton Depression Ratind Scale) Difference HAMD score between the intervention and control group from baseline to 3 month follow-up

Secondary Outcome Measures

Depression response and remissionhealth related quality of life
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
Reduced suicide ideation
SSI (Beck's suicide ieation scale) Difference total SSI scores Between the two groups from baseline to each follow-up periods
Improvement of Quality of life
EQ5D Difference EQ5D scores Between the two groups from baseline to each follow-up periods

Full Information

First Posted
June 20, 2012
Last Updated
March 10, 2016
Sponsor
National Clinical Research Coordination Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01626716
Brief Title
Collaborative Care for Depressed Elderly in Korea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Clinical Research Coordination Center, Seoul, Korea

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Elderly, Korean, Collaborative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
case management
Arm Type
Experimental
Arm Description
patients who assigned to the intervention group will take 7 times phone calls from case manager
Arm Title
control
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
care management
Intervention Description
patients who assigned to the intervention group will take 7 times phone calls from case manager
Primary Outcome Measure Information:
Title
Reduced depression symptoms
Description
HAMD (Hamilton Depression Ratind Scale) Difference HAMD score between the intervention and control group from baseline to 3 month follow-up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Depression response and remissionhealth related quality of life
Description
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
Time Frame
3months and 6months
Title
Reduced suicide ideation
Description
SSI (Beck's suicide ieation scale) Difference total SSI scores Between the two groups from baseline to each follow-up periods
Time Frame
3 months and 6 months
Title
Improvement of Quality of life
Description
EQ5D Difference EQ5D scores Between the two groups from baseline to each follow-up periods
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 year or older diagnosed depression based on DSM-IV criteria Exclusion Criteria: impairment of hearing dementia other psychiatric disorders
Facility Information:
Facility Name
Chungju community health care center
City
Chungju
State/Province
ChoongBuk
ZIP/Postal Code
123456
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Collaborative Care for Depressed Elderly in Korea

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