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

Chronic Obstructive Pulmonary Disease Clinical Trial

— BOC  

Official title:

The Economic Burden of Patients With COPD in South Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750189
• Other study ID #: KUH1010636
• Status: Completed
• Phase: N/A
• First received: March 28, 2016
• Last updated: July 18, 2017
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2017
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Over 20 years old

• COPD patients

Exclusion Criteria:

• Patients who disagree with participating in research

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Direct cost
Money spent to treat COPD in medical institute based on HIRA
• Indirect cost
extra-expanses excluding hospital fees

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Hospital	Gwangjin gu	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Konkuk University Medical Center	GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

Dang-Tan T, Ismaila A, Zhang S, Zarotsky V, Bernauer M. Clinical, humanistic, and economic burden of chronic obstructive pulmonary disease (COPD) in Canada: a systematic review. BMC Res Notes. 2015 Sep 21;8:464. doi: 10.1186/s13104-015-1427-y. Review. — View Citation

Guarascio AJ, Ray SM, Finch CK, Self TH. The clinical and economic burden of chronic obstructive pulmonary disease in the USA. Clinicoecon Outcomes Res. 2013 Jun 17;5:235-45. doi: 10.2147/CEOR.S34321. Print 2013. — View Citation

Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. Epub 2006 Apr 12. Review. — View Citation

Kim J, Lee TJ, Kim S, Lee E. The economic burden of chronic obstructive pulmonary disease from 2004 to 2013. J Med Econ. 2016;19(2):103-10. doi: 10.3111/13696998.2015.1100114. Epub 2015 Oct 19. — View Citation

Løkke A, Hilberg O, Tønnesen P, Ibsen R, Kjellberg J, Jennum P. Direct and indirect economic and health consequences of COPD in Denmark: a national register-based study: 1998-2010. BMJ Open. 2014 Jan 6;4(1):e004069. doi: 10.1136/bmjopen-2013-004069. — View Citation

Mannino DM, Higuchi K, Yu TC, Zhou H, Li Y, Tian H, Suh K. Economic Burden of COPD in the Presence of Comorbidities. Chest. 2015 Jul;148(1):138-150. doi: 10.1378/chest.14-2434. — View Citation

Sullivan SD, Ramsey SD, Lee TA. The economic burden of COPD. Chest. 2000 Feb;117(2 Suppl):5S-9S. — View Citation

Teo WS, Tan WS, Chong WF, Abisheganaden J, Lew YJ, Lim TK, Heng BH. Economic burden of chronic obstructive pulmonary disease. Respirology. 2012 Jan;17(1):120-6. doi: 10.1111/j.1440-1843.2011.02073.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cost of COPD	Korean won, KRW	1 year
Secondary	The number of acute exacerbations	Number of events	1 year
Secondary	The cost of alternative medication use	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
Secondary	Cost of productivity lost	Reduction of working hour and monthly income for being late or abscence from work.	Last 7days from filling out questionnaires
Secondary	EuroQol five dimension(EQ-5D)	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
Secondary	The total number of visits	primary clinics, emergency department and hospital admission.	1 year
Secondary	Nursing cost	payment for nurse (Korean won, KRW)	1 year (past 1 year before filling questionnaires)

External Links

•   Health insurance review agency in south korea