Clinical trial NCT02750189: The Economic Burden of Chronic Obstructive Pulmonary Disease(COPD) in South Korea
Official title: The Economic Burden of Patients With COPD in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2016-04-25
Enrollment: 390
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease (COPD)

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.

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.

Eligibility criteria: Inclusion Criteria:

* Over 20 years old
* COPD patients

Exclusion Criteria:

* Patients who disagree with participating in research

Primary outcomes:
measure: Total cost of COPD
timeFrame: 1 year
Secondary outcomes:
measure: The number of acute exacerbations
timeFrame: 1 year
measure: The cost of alternative medication use
timeFrame: three months
measure: Cost of productivity lost
timeFrame: Last 7days from filling out questionnaires
measure: EuroQol five dimension(EQ-5D)
timeFrame: 3 months
measure: The total number of visits
timeFrame: 1 year
measure: Nursing cost
timeFrame: 1 year (past 1 year before filling questionnaires)
Other outcomes:
Locations:
city: Gwangjin gu
country: Korea, Republic of
facility: Konkuk University Hospital
state: Seoul
Study officials:
affiliation: Konkuk University Hospial
name: Kwang-Ha NA Yoo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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