Collaborative Care for Depressed Elderly in Korea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by National Clinical Research Coordination Center, Seoul, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Clinical Research Coordination Center, Seoul, Korea
ClinicalTrials.gov Identifier:
NCT01626716
First received: June 20, 2012
Last updated: June 22, 2012
Last verified: June 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reduced depression symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    EQ5D Difference EQ5D scores Between the two groups from baseline to each follow-up periods


Estimated Enrollment: 200
Study Start Date: June 2012
Intervention Details:
    Other: care management
    patients who assigned to the intervention group will take 7 times phone calls from case manager
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626716

Contacts
Contact: Hyeon-Woo Yim, MD, Ph.D +82-2-2258-7860 y1693@catholic.ac.kr
Contact: Hyunsuk Sue Jeong, MA +82-2-2258-7372 suejeong@catholic.ac.kr

Locations
Korea, Republic of
Chungju community health care center Recruiting
Chungju, ChoongBuk, Korea, Republic of, 123456
Contact: Moon-Soon Song, BA    +82-43-850-3510    sms5609@korea.kr   
Sponsors and Collaborators
National Clinical Research Coordination Center, Seoul, Korea
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01626716     History of Changes
Other Study ID Numbers: A102065_2012_1
Study First Received: June 20, 2012
Last Updated: June 22, 2012
Health Authority: Korea:Ministry of Health and Welfare

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014