NCT02750189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

March 28, 2016

Last Update Submit

July 18, 2017

Conditions

COPDChronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Total cost of COPD

    Korean won, KRW

    1 year

Secondary Outcomes (6)

  • The number of acute exacerbations

    1 year

  • The cost of alternative medication use

    three months

  • Cost of productivity lost

    Last 7days from filling out questionnaires

  • EuroQol five dimension(EQ-5D)

    3 months

  • The total number of visits

    1 year

  • +1 more secondary outcomes

Study Arms (4)

Mild Group

FEV₁/FVC \<70% and FEV₁≥80% direct/indirect cost

Other: Direct costOther: Indirect cost

Moderate Group

FEV₁/FVC \<70% and 50%≤FEV₁≤80% direct/indirect cost

Other: Direct costOther: Indirect cost

Severe Group

FEV₁/FVC \<70% and 30%≤FEV₁≤50% direct/indirect cost

Other: Direct costOther: Indirect cost

Very Severe Group

FEV₁/FVC \<70% and FEV₁\<30% direct/indirect cost

Other: Direct costOther: Indirect cost

Interventions

Direct costOTHER

Money spent to treat COPD in medical institute based on HIRA

Mild GroupModerate GroupSevere GroupVery Severe Group
Indirect costOTHER

extra-expanses excluding hospital fees

Mild GroupModerate GroupSevere GroupVery Severe Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chronic Obstructive Pulmonary Disease (COPD)

You may qualify if:

  • Over 20 years old
  • COPD patients

You may not qualify if:

  • Patients who disagree with participating in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Hospital

Gwangjin Gu, Seoul, 05030, South Korea

Location

Related Publications (8)

  • 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.

    PMID: 23818799BACKGROUND

  • 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.

    PMID: 26391471BACKGROUND

  • Lokke A, Hilberg O, Tonnesen 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.

    PMID: 24394800BACKGROUND

  • Sullivan SD, Ramsey SD, Lee TA. The economic burden of COPD. Chest. 2000 Feb;117(2 Suppl):5S-9S. doi: 10.1378/chest.117.2_suppl.5s.

    PMID: 10673466BACKGROUND

  • 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.

    PMID: 25675282BACKGROUND

  • 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.

    PMID: 21954985BACKGROUND

  • 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. doi: 10.1183/09031936.06.00124605. Epub 2006 Apr 12.

    PMID: 16611654BACKGROUND

  • 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.

    PMID: 26414920BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Direct Service Costs

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care CostsCosts and Cost AnalysisEconomicsHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Kwang-Ha NA Yoo, Doctor

    Konkuk University Hospial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 25, 2016

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

KR(1)