Major Depressive DisordersNCT01347138
Health Care Management for the Elderly in Community Through Screening
A study testing case management in people with Major Depressive Disorders and Senile; Depression, run by National Clinical Research Coordination Center, Seoul, Korea at 1 site in South Korea.
Trial summary
Depression in late life has been associated with losses in functioning and quality of life, mortality, and increased health care costs. Although late life depression can be successfully treated with antidepressant medication or psychotherapy, few older adults receive adequate trials of such treatment in community in… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorders, Senile; Depression
- What is being tested?
- case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Apr 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 60 year old
- having medicare insurance
Who cannot join
- dementia and other psychiatric disorders
Trial locations and contacts
1 site in 1 country.
South Korea1 site
City of Choongju public health center
Choongju, Choongchungbuk-Do
About this study
Depression in late life has been associated with losses in functioning and quality of life, mortality, and increased health care costs. Although late life depression can be successfully treated with antidepressant medication or psychotherapy, few older adults receive adequate trials of such treatment in community in Korea. Barriers, such as loss of loved ones, medical illnesses, and social stigma associated with depression, lack of social and financial support, to effective treatment of depression can be especially problematic for older adult. Screening has been valuable in overcoming barriers to diagnosis. Over 60 year old community dwelling people will be screened for symptoms of four geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder). Those who will be screened positive for each condition will be refer to clinic for diagnosis. Among them only those cases confirmed as depression by psychiatrists will be enrolled in this study. Enrolled patients will be randomly assigned to either case management or usual care conditions.
The objective of the study is to test whether a system of screening, assessment, and follow-up provided by case manager improves in recognizing the target geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder) and healthcare outcomes.
- Conditions
- Major Depressive Disorders, Senile; Depression
- Being tested
- case management
- Keywords
- Screening, depression, case management
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case managementOther
confirmation of hospital visit date, checking the adverse effect and treatment compliance
| Study group | Role | What they receive |
|---|---|---|
| case management | Experimental | case management regulary Receives: Other: case management |
| Control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Score
Measured: 6 months after baseline
Secondary outcomes (3)
quality of life
Measured: 6 months after baseline
treatment compliance
Measured: 6 months after baseline
suicide ideation
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisordersStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 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
- Investigators
- Hyeon Woo Yim, MD. Ph.D., Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347138
- Sponsor's protocol ID
- A102065
- Status last verified
- Mar 2016
- First submitted
- 27 Apr 2011
- 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
- Health Care Management for the Elderly in Community Through Screening
- ClinicalTrials.gov ID
- NCT01347138
- Acronym / sponsor ID
- A102065
- Conditions
- Major Depressive Disorders, Senile; Depression
- Keywords
- Screening, depression, case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- National Clinical Research Coordination Center, Seoul, KoreaOther government
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 May 2011 (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.
Depression in late life has been associated with losses in functioning and quality of life, mortality, and increased health care costs. Although late life depression can be successfully treated with antidepressant medication or psychotherapy, few older adults receive adequate trials of such treatment in community in Korea. Barriers, such as loss of loved ones, medical illnesses, and social stigma associated with depression, lack of social and financial support, to effective treatment of depression can be especially problematic for older adult. Screening has been valuable in overcoming barriers to diagnosis. Over 60 year old community dwelling people will be screened for symptoms of four geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder). Those who will be screened positive for each condition will be refer to clinic for diagnosis. Among them only those cases confirmed as depression by psychiatrists will be enrolled in this study. Enrolled patients will be randomly assigned to either case management or usual care conditions.
The objective of the study is to test whether a system of screening, assessment, and follow-up provided by case manager improves in recognizing the target geriatric conditions (depression, dementia, urinary incontinence, and sleep disorder) and healthcare outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case management | Experimental | Other: case managementcase management regulary |
| Control | No intervention | –usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 60 year old
- having medicare insurance
Key exclusion criteria (1 listed)
- dementia and 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 |
|---|---|---|
| case managementconfirmation of hospital visit date, checking the adverse effect and treatment compliance | Other | case management |
Primary outcome
Geriatric Depression Score
Time frame: 6 months after baseline
3 secondary outcomes
quality of life
Time frame: 6 months after baseline
treatment compliance
Time frame: 6 months after baseline
suicide ideation
Time frame: 6 months after baseline
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.
Hyeon Woo Yim, MD. Ph.D. principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing case management in people with Major Depressive Disorders and Senile; Depression, 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 1 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?
Geriatric Depression Score (time frame: 6 months after baseline). 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.