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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01626716
Other study ID # A102065_2012_1
Secondary ID
Status Completed
Phase N/A
First received June 20, 2012
Last updated March 10, 2016
Start date June 2012
Est. completion date December 2013

Study information

Verified date March 2016
Source National Clinical Research Coordination Center, Seoul, Korea
Contact n/a
Is FDA regulated No
Health authority Korea:Ministry of Health and Welfare
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 60 year or older

- diagnosed depression based on DSM-IV criteria

Exclusion Criteria:

- impairment of hearing

- dementia

- other psychiatric disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Chungju community health care center Chungju ChoongBuk

Sponsors (1)

Lead Sponsor Collaborator
National Clinical Research Coordination Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduced depression symptoms HAMD (Hamilton Depression Ratind Scale) Difference HAMD score between the intervention and control group from baseline to 3 month follow-up 3 months No
Secondary 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
3months and 6months No
Secondary Reduced suicide ideation 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 No
Secondary Improvement of Quality of life EQ5D Difference EQ5D scores Between the two groups from baseline to each follow-up periods 3 months and 6 months No
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