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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01727219
Other study ID # 2011-I010
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 12, 2012
Last updated November 18, 2012
Start date December 2012
Est. completion date May 2013

Study information

Verified date February 2011
Source Hallym University Medical Center
Contact Sunghoon Park, Dr.
Phone 82-31-380-3803
Email f2000tj@gmail.com
Is FDA regulated No
Health authority Korea: Ministry for Health and Welfare
Study type Observational

Clinical 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.

In this prospective study, we will investigate the predictive utility of CAT for predicting depression in COPD patients.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date May 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- COPD patients who aged > or = 40 years

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital, Department of Pulmonary, Critical Care Medicine Anyang- Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The predictive utility of the COPD assessment test (CAT) scores for predicting depression in COPD patients The association of CAT with depression score 1 year No
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