The Economic Burden of Chronic Obstructive Pulmonary Disease(COPD) in South Korea (BOC)

July 18, 2017 updated by: Kwang-Ha Yoo, Konkuk University Medical Center

The Economic Burden of Patients With COPD in South Korea

The purpose of this study is to estimate a direct/indirect medical cost and to provide evidence establishing efficient strategies to reduce medical costs of COPD in Korea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center research on economic burdens of COPD for a year. It is composed of three phases detailed as follow.

Phase 1: Direct Cost Estimation in COPD patients (N = 400) Direct cost determined as amount of money expended to medical institutes for treatment. Estimated costs, based on the information from Health insurance review agency(HIRA) and The National Health and Nutrition Examination Survey (NHANES) data, are collected.

Phase 2: Indirect cost Estimation by Sampling Survey in COPD patient Indirect cost is extra-expanses excluding hospital fees, including cost for transportation, medical instruments, home care services and loss of labor capacity reduction. The information was collected by structured questionnaire for 12 weeks.

Phase 3: Direct/Indirect cost is validated and analyzed based on the collected information from phase 1 and 2 according to severity defined by the GOLD guideline.

Study Type

Observational

Enrollment (Actual)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Gwangjin gu, Seoul, Korea, Republic of, 05030
        • Konkuk University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease (COPD)

Description

Inclusion Criteria:

  • Over 20 years old
  • COPD patients

Exclusion Criteria:

  • Patients who disagree with participating in research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mild Group
FEV₁/FVC <70% and FEV₁≥80% direct/indirect cost
Other: Direct cost
Money spent to treat COPD in medical institute based on HIRA
Other: Indirect cost
extra-expanses excluding hospital fees
Moderate Group
FEV₁/FVC <70% and 50%≤FEV₁≤80% direct/indirect cost
Other: Direct cost
Money spent to treat COPD in medical institute based on HIRA
Other: Indirect cost
extra-expanses excluding hospital fees
Severe Group
FEV₁/FVC <70% and 30%≤FEV₁≤50% direct/indirect cost
Other: Direct cost
Money spent to treat COPD in medical institute based on HIRA
Other: Indirect cost
extra-expanses excluding hospital fees
Very Severe Group
FEV₁/FVC <70% and FEV₁<30% direct/indirect cost
Other: Direct cost
Money spent to treat COPD in medical institute based on HIRA
Other: Indirect cost
extra-expanses excluding hospital fees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cost of COPD
Time Frame: 1 year
Korean won, KRW
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of acute exacerbations
Time Frame: 1 year
Number of events
1 year
The cost of alternative medication use
Time Frame: three months
We will add up the costs of herbal medicine, health supplement, medical equipments and respiratory rehabilitation. According to patients, the items of alternative medication use would be different.
three months
Cost of productivity lost
Time Frame: Last 7days from filling out questionnaires
Reduction of working hour and monthly income for being late or abscence from work.
Last 7days from filling out questionnaires
EuroQol five dimension(EQ-5D)
Time Frame: 3 months
Measured by questionnaire based by EQ -5D ( EQ-5D essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) . The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems )
3 months
The total number of visits
Time Frame: 1 year
primary clinics, emergency department and hospital admission.
1 year
Nursing cost
Time Frame: 1 year (past 1 year before filling questionnaires)
payment for nurse (Korean won, KRW)
1 year (past 1 year before filling questionnaires)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Kwang-Ha NA Yoo, Doctor, Konkuk University Hospial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1010636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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