Depression,NCT01727219
COPD Assessment Test Can Predict Depression
An observational study of Depression, and COPD, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
The frequency of depression in COPD patients are substantial and early detection and prevention of depression is critical. Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD on patients' quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Depression,, COPD
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to May 2013
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable COPD patients who visit outpatient departments.
Who may be able to join
- COPD patients who aged > or = 40 years
Who cannot join
- acute exacerbation within 3 months
- bronchial asthma or an increase in FEV1 of more than 12% of the predicted value with the use of 400 µg of albuterol.
- other lung diseases such as bronchiectasis, interstitial lung disease, and tuberculosis-destroyed lungs.
- who denied to consent.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital, Department of Pulmonary, Critical Care Medicine
Anyang-si, Gyeonggi-do, 431-070
Sunghoon Park, MD, 82-31-380-3803, f2000tj@gmail.com
Sun Hyang Kim, 82-31-380-1975, tjsgid625@naver.com
About this study
The frequency of depression in COPD patients are substantial and early detection and prevention of depression is critical.
Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD on patients' quality of life.
In this prospective study, we will investigate the predictive utility of CAT for predicting depression in COPD patients.
Read the detailed description
This study is aimed to investigate the association between the COPD Assessment Test (CAT) and depression in stable COPD patients. Stable COPD patients will be enrolled from the tertiary hospitals. All patients will undergo lung function tests. The Korean versions of the CAT (COPD assessment test) and Patient Health Questionnaire-9 (PHQ-9) will be used to assess COPD symptoms and depressive disorder, respectively.
We will compare the depresssion frequency among GOLD classifications of airway limitation and among the four CAT groups. And. we will also investigate which items of the CAT are the strongest indicators of depression.
- Conditions
- Depression,, COPD
- Medical subject headings
- Depression, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive utility of the COPD assessment test (CAT) scores for predicting depression in COPD patients
The association of CAT with depression score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression,Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KI-Suck Jung, Dr., Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727219
- Sponsor's protocol ID
- 2011-I010
- Status last verified
- Feb 2011
- First submitted
- 12 Nov 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD Assessment Test Can Predict Depression
- ClinicalTrials.gov ID
- NCT01727219
- Acronym / sponsor ID
- 2011-I010
- Conditions
- Depression,, COPD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 15 Nov 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.
The frequency of depression in COPD patients are substantial and early detection and prevention of depression is critical.
Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD on patients' quality of life.
In this prospective study, we will investigate the predictive utility of CAT for predicting depression in COPD patients.
Detailed description
This study is aimed to investigate the association between the COPD Assessment Test (CAT) and depression in stable COPD patients. Stable COPD patients will be enrolled from the tertiary hospitals. All patients will undergo lung function tests. The Korean versions of the CAT (COPD assessment test) and Patient Health Questionnaire-9 (PHQ-9) will be used to assess COPD symptoms and depressive disorder, respectively.
We will compare the depresssion frequency among GOLD classifications of airway limitation and among the four CAT groups. And. we will also investigate which items of the CAT are the strongest indicators of depression.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable COPD patients who visit outpatient departments.
Key inclusion criteria (1 listed)
- COPD patients who aged > or = 40 years
Key exclusion criteria (4 listed)
- acute exacerbation within 3 months
- bronchial asthma or an increase in FEV1 of more than 12% of the predicted value with the use of 400 µg of albuterol.
- other lung diseases such as bronchiectasis, interstitial lung disease, and tuberculosis-destroyed lungs.
- who denied to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The predictive utility of the COPD assessment test (CAT) scores for predicting depression in COPD patients
Time frame: 1 year
The association of CAT with depression score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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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.
KI-Suck Jung, Dr. principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, and COPD, run by Hallym University Medical Center 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Nov 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sunghoon Park, Dr. (82-31-380-3803, f2000tj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predictive utility of the COPD assessment test (CAT) scores for predicting depression in COPD patients (time frame: 1 year). 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 20 Nov 2012.