COPD Assessment Test Can Predict Depression | NCT01727219

Studies
COPD Assessment Test Can Predict Depression

NCT01727219

Sponsor

Hallym University Medical Center

Status

Unknown status

Last Update Posted

Nov 20, 2012Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Depression,
COPD

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Feb 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Nov 12, 2012

First Submission Date that Met QC Criteria

Nov 14, 2012

First Posted Date

Nov 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2012

Last Update Posted Date

Nov 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stable COPD patients who visit outpatient departments.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sunghoon Park, Dr.	Contact	82-31-380-3803		f2000tj@gmail.com

Overall Officials

Name	Affiliation	Role
KI-Suck Jung, Dr.	Hallym University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital, Department of Pulmonary, Critical Care Medicine		Anyang-si	Gyeonggi-do	431-070	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

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Browse Branches

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