DepressionNCT01626716
Collaborative Care for Depressed Elderly in Korea
A study testing care management in people with Depression and Elderly, run by National Clinical Research Coordination Center, Seoul, Korea at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Elderly, Korean
- What is being tested?
- care management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 year or older
- diagnosed depression based on DSM-IV criteria
Who cannot join
- impairment of hearing
- dementia
- other psychiatric disorders
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungju community health care center
Chungju, ChoongBuk, 123456
About this study
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.
- Conditions
- Depression, Elderly, Korean, Collaborative Care
- Being tested
- care management
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care managementOther
patients who assigned to the intervention group will take 7 times phone calls from case manager
| Study group | Role | What they receive |
|---|---|---|
| case management | Experimental | patients who assigned to the intervention group will take 7 times phone calls from case manager Receives: Other: care management |
| control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced depression symptoms
HAMD (Hamilton Depression Ratind Scale) Difference HAMD score between the intervention and control group from baseline to 3 month follow-up
Measured: 3 months
Secondary outcomes (3)
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
Measured: 3months and 6months
Reduced suicide ideation
SSI (Beck's suicide ieation scale) Difference total SSI scores Between the two groups from baseline to each follow-up periods
Measured: 3 months and 6 months
Improvement of Quality of life
EQ5D Difference EQ5D scores Between the two groups from baseline to each follow-up periods
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Clinical Research Coordination Center, Seoul, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hyeon Woo Yim, National Clinical Research Coordination Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626716
- Sponsor's protocol ID
- A102065_2012_1
- Status last verified
- Mar 2016
- First submitted
- 20 Jun 2012
- Last updated
- 11 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Depressed Elderly in Korea
- ClinicalTrials.gov ID
- NCT01626716
- Acronym / sponsor ID
- A102065_2012_1
- Conditions
- Depression, Elderly, Korean, Collaborative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Clinical Research Coordination Center, Seoul, KoreaOther government
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case management | Experimental | Other: care managementpatients who assigned to the intervention group will take 7 times phone calls from case manager |
| control | No intervention | –usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 year or older
- diagnosed depression based on DSM-IV criteria
Key exclusion criteria (3 listed)
- impairment of hearing
- dementia
- other psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| care managementpatients who assigned to the intervention group will take 7 times phone calls from case manager | Other | case management |
Primary outcome
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
3 secondary outcomes
Depression response and remissionhealth related quality of life
Time frame: 3months and 6months
Reduced suicide ideation
Time frame: 3 months and 6 months
Improvement of Quality of life
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing care management in people with Depression and Elderly, run by National Clinical Research Coordination Center, Seoul, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced depression symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.