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

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ClinicalTrials.gov Identifier: NCT02750189
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kwang-Ha Yoo, Konkuk University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
COPD Chronic Obstructive Pulmonary Disease Other: Direct cost Other: Indirect cost

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.


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Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: The Economic Burden of Patients With COPD in South Korea
Study Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

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




Primary Outcome Measures :
  1. Total cost of COPD [ Time Frame: 1 year ]
    Korean won, KRW


Secondary Outcome Measures :
  1. The number of acute exacerbations [ Time Frame: 1 year ]
    Number of events

  2. 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.

  3. 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.

  4. 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 )

  5. The total number of visits [ Time Frame: 1 year ]
    primary clinics, emergency department and hospital admission.

  6. Nursing cost [ Time Frame: 1 year (past 1 year before filling questionnaires) ]
    payment for nurse (Korean won, KRW)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic Obstructive Pulmonary Disease (COPD)
Criteria

Inclusion Criteria:

  • Over 20 years old
  • COPD patients

Exclusion Criteria:

  • Patients who disagree with participating in research

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750189


Locations
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Korea, Republic of
Konkuk University Hospital
Gwangjin gu, Seoul, Korea, Republic of, 05030
Sponsors and Collaborators
Konkuk University Medical Center
GlaxoSmithKline
Investigators
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Principal Investigator: Kwang-Ha NA Yoo, Doctor Konkuk University Hospial

Additional Information:
Publications:

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Responsible Party: Kwang-Ha Yoo, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02750189     History of Changes
Other Study ID Numbers: KUH1010636
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases