COPDBOCNCT02750189
The Economic Burden of Chronic Obstructive Pulmonary Disease(COPD) in South Korea
An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by Konkuk University Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Direct cost and Indirect cost
- How many people
- 390 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic Obstructive Pulmonary Disease (COPD)
Who may be able to join
- Over 20 years old
- COPD patients
Who cannot join
- Patients who disagree with participating in research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- Direct cost, Indirect cost
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct costOther
Money spent to treat COPD in medical institute based on HIRA
Indirect costOther
extra-expanses excluding hospital fees
| Study group | Role | What they receive |
|---|---|---|
| Mild Group | FEV₁/FVC <70% and FEV₁≥80% direct/indirect cost Receives: Other: Direct cost; Other: Indirect cost | |
| Moderate Group | FEV₁/FVC <70% and 50%≤FEV₁≤80% direct/indirect cost Receives: Other: Direct cost; Other: Indirect cost | |
| Severe Group | FEV₁/FVC <70% and 30%≤FEV₁≤50% direct/indirect cost Receives: Other: Direct cost; Other: Indirect cost | |
| Very Severe Group | FEV₁/FVC <70% and FEV₁<30% direct/indirect cost Receives: Other: Direct cost; Other: Indirect cost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cost of COPD
Korean won, KRW
Measured: 1 year
Secondary outcomes (6)
The number of acute exacerbations
Number of events
Measured: 1 year
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.
Measured: three months
Cost of productivity lost
Reduction of working hour and monthly income for being late or abscence from work.
Measured: Last 7days from filling out questionnaires
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 )
Measured: 3 months
The total number of visits
primary clinics, emergency department and hospital admission.
Measured: 1 year
Nursing cost
payment for nurse (Korean won, KRW)
Measured: 1 year (past 1 year before filling questionnaires)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Kwang-Ha Yoo, Konkuk University Medical Center
- Investigators
- Kwang-Ha NA Yoo, Doctor, Principal investigator, Konkuk University Hospial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750189
- Sponsor's protocol ID
- KUH1010636
- Acronym
- BOC
- Status last verified
- Jul 2017
- First submitted
- 28 Mar 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23818799Dang-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.
PubMed 26391471Lokke 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.
PubMed 24394800Sullivan 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.
PubMed 10673466Mannino 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.
PubMed 25675282Teo 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.
PubMed 21954985Halbert 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.
PubMed 16611654Kim 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.
PubMed 26414920
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Economic Burden of Patients With COPD in South Korea
- ClinicalTrials.gov ID
- NCT02750189
- Acronym / sponsor ID
- BOC / KUH1010636
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Group | – | Other: Direct cost, Other: Indirect costFEV₁/FVC <70% and FEV₁≥80% direct/indirect cost |
| Moderate Group | – | Other: Direct cost, Other: Indirect costFEV₁/FVC <70% and 50%≤FEV₁≤80% direct/indirect cost |
| Severe Group | – | Other: Direct cost, Other: Indirect costFEV₁/FVC <70% and 30%≤FEV₁≤50% direct/indirect cost |
| Very Severe Group | – | Other: Direct cost, Other: Indirect costFEV₁/FVC <70% and FEV₁<30% direct/indirect cost |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Obstructive Pulmonary Disease (COPD)
Key inclusion criteria (2 listed)
- Over 20 years old
- COPD patients
Key exclusion criteria (1 listed)
- Patients who disagree with participating in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct costMoney spent to treat COPD in medical institute based on HIRA | Other | Mild Group, Moderate Group, Severe Group, Very Severe Group |
| Indirect costextra-expanses excluding hospital fees | Other | Mild Group, Moderate Group, Severe Group, Very Severe Group |
Primary outcome
Total cost of COPD
Time frame: 1 year
Korean won, KRW
6 secondary outcomes
The number of acute exacerbations
Time frame: 1 year
The cost of alternative medication use
Time frame: three months
Cost of productivity lost
Time frame: Last 7days from filling out questionnaires
EuroQol five dimension(EQ-5D)
Time frame: 3 months
The total number of visits
Time frame: 1 year
Nursing cost
Time frame: 1 year (past 1 year before filling questionnaires)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 23818799Guarascio 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.
- Background: PubMed 26391471Dang-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.
- Background: PubMed 24394800Lokke 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.
- Background: PubMed 10673466Sullivan 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.
- Background: PubMed 25675282Mannino 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.
- Background: PubMed 21954985Teo 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.
- Background: PubMed 16611654Halbert 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.
- Background: PubMed 26414920Kim 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.
- Health insurance review agency in south koreaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwang-Ha NA Yoo, Doctor principal investigator
Konkuk University Hospial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cost of COPD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750189, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.