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Collaborative Care for Depressed Elderly in Korea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626716
First Posted: June 25, 2012
Last Update Posted: March 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyeon Woo Yim, National Clinical Research Coordination Center, Seoul, Korea
  Purpose
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.

Condition Intervention
Depression Elderly Korean Collaborative Care Other: care management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Hyeon Woo Yim, National Clinical Research Coordination Center, Seoul, Korea:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


  • 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

  • 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


Enrollment: 80
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: control
usual care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • impairment of hearing
  • dementia
  • other psychiatric disorders
  Contacts and Locations
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): NCT01626716


Locations
Korea, Republic of
Chungju community health care center
Chungju, ChoongBuk, Korea, Republic of, 123456
Sponsors and Collaborators
National Clinical Research Coordination Center, Seoul, Korea
  More Information

Responsible Party: Hyeon Woo Yim, Professor, National Clinical Research Coordination Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT01626716     History of Changes
Other Study ID Numbers: A102065_2012_1
First Submitted: June 20, 2012
First Posted: June 25, 2012
Last Update Posted: March 11, 2016
Last Verified: March 2016