NCT01626716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

June 20, 2012

Last Update Submit

March 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Depression response and remissionhealth related quality of life

    3months and 6months

  • Reduced suicide ideation

    3 months and 6 months

  • Improvement of Quality of life

    3 months and 6 months

Study Arms (2)

case management

EXPERIMENTAL

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

Other: care management

control

NO INTERVENTION

usual care

Interventions

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

case management

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • impairment of hearing
  • dementia
  • other psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungju community health care center

Chungju, ChoongBuk, 123456, South Korea

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 25, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 11, 2016

Record last verified: 2016-03

Locations