COPDNCT02827929
Efficacy of Education Programs in Patients With Chronic Airway Diseases
A study testing Education in people with COPD and Asthma, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The objective of this study is to determine whether the systematic education on air way disease and inhalers in outpatient settings contributes to improve the quality of life. Education has been known to be effective for management of chronic airway disease. However, the real benefits remain unclear. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Mar 2016
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as asthma or COPD
- Patients of over 20 years old
- Patients who agree with voluntary informed consent
- Patients who were prescribed inhaler medication as treatment option
Who cannot join
- Patients who have comorbid disorders which can influence on the study result (e.g. severe cardiac or kidney disease, cancer, transplantation, bronchiectasis, tuberculous destroyed lung)
- Pregnant women
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine whether the systematic education on air way disease and inhalers in outpatient settings contributes to improve the quality of life.
Education has been known to be effective for management of chronic airway disease. However, the real benefits remain unclear. An organized education on the chronic airway disease is directed by primary care physicians, and the investigators evaluate the effectiveness of the education.
Read the detailed description
The present study is a prospective and interventional study comparing the outcomes of education program for one month.
A one month education program is composed of three visits (every two weeks follow-up ) during which subjects were taught about their diseases, action plans in acute exacerbation, and inhaler technique.
To evaluate the effectiveness of systematic education, questionnaires evaluating quality of life and satisfaction of education will be examined after each visit.
Asthma control test (ACT) in asthma, chronic obstructive pulmonary disease (COPD) assessment test (CAT) in COPD subjects were compared before and after education as an index of quality of life.
Educational effects were also measured, associated with improvement of their knowledge for chronic airway disease itself, proper use of inhaler technique, and satisfaction of subjects after education.
- Being tested
- Education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
3 times systemic education program will be provided to patients were diagnosed as asthma or COPD by their physicians.
| Study group | Role | What they receive |
|---|---|---|
| educated group | Experimental | Subjects who is diagnosed as COPD or asthma by their physicians were recruited from 43 primary clinic and had been visiting each primary clinic over one year or more will be provided education of 3 times for one months about disease, inhaler use technics and action plans about exacerbation Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CAT score
The investigators examined change of quality of life through CAT in patient with COPD.
Measured: one month
Secondary outcomes (6)
Change in ACT score
The investigators examined change of quality of life through Asthma control test in patient with asthma.
Measured: one month
Medical cost
The investigators will compare the total medical cost related COPD or asthma before education with that after education. (unit: Korean won, KRW)
Measured: one month
Compliance to Medication
Compliance is calculated as the ratio between the number of actual doses and the number of doses that should have been taken during the total treatment period. The investigators will compare the ratio before and after education about air way disease
Measured: one month
patients satisfaction score with the education program
Measured: one month
physicians satisfaction score with the education program
Measured: one month
the time of acute exacerbation
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang-Ha Yoo, Konkuk University Medical Center
- Investigators
- Kwang-Ha NA Yoo, M.D, Principal investigator, Konkuk University Hospial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827929
- Sponsor's protocol ID
- ESR-14-10193
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Valero C, Monteagudo M, Llagostera M, Bayona X, Granollers S, Acedo M, Ferro JJ, Rodriguez-Latre L, Almeda J, Munoz L; COPD Group of SAP Baix LLobregat Centre. Evaluation of a combined strategy directed towards health-care professionals and patients with chronic obstructive pulmonary disease (COPD): information and health education feedback for improving clinical monitoring and quality-of-life. BMC Public Health. 2009 Dec 1;9:442. doi: 10.1186/1471-2458-9-442.
PubMed 20128887Wacker ME, Jorres RA, Karch A, Wilke S, Heinrich J, Karrasch S, Koch A, Schulz H, Watz H, Leidl R, Vogelmeier C, Holle R; COSYCONET-Consortium. Assessing health-related quality of life in COPD: comparing generic and disease-specific instruments with focus on comorbidities. BMC Pulm Med. 2016 May 10;16(1):70. doi: 10.1186/s12890-016-0238-9.
PubMed 27160582Koblizek V, Novotna B, Zbozinkova Z, Hejduk K. Diagnosing COPD: advances in training and practice - a systematic review. Adv Med Educ Pract. 2016 Apr 4;7:219-31. doi: 10.2147/AMEP.S76976. eCollection 2016.
PubMed 27099544Leiva-Fernandez J, Vazquez-Alarcon RL, Aguiar-Leiva V, Lobnig-Becerra M, Leiva-Fernandez F, Barnestein-Fonseca P. Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial. Trials. 2016 Mar 17;17(1):144. doi: 10.1186/s13063-016-1269-5.
PubMed 26988095
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Education Programs in Patients With Chronic Airway Diseases
- ClinicalTrials.gov ID
- NCT02827929
- Acronym / sponsor ID
- ESR-14-10193
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Jul 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 objective of this study is to determine whether the systematic education on air way disease and inhalers in outpatient settings contributes to improve the quality of life.
Education has been known to be effective for management of chronic airway disease. However, the real benefits remain unclear. An organized education on the chronic airway disease is directed by primary care physicians, and the investigators evaluate the effectiveness of the education.
Detailed description
The present study is a prospective and interventional study comparing the outcomes of education program for one month.
A one month education program is composed of three visits (every two weeks follow-up ) during which subjects were taught about their diseases, action plans in acute exacerbation, and inhaler technique.
To evaluate the effectiveness of systematic education, questionnaires evaluating quality of life and satisfaction of education will be examined after each visit.
Asthma control test (ACT) in asthma, chronic obstructive pulmonary disease (COPD) assessment test (CAT) in COPD subjects were compared before and after education as an index of quality of life.
Educational effects were also measured, associated with improvement of their knowledge for chronic airway disease itself, proper use of inhaler technique, and satisfaction of subjects after education.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| educated group | Experimental | Behavioral: EducationSubjects who is diagnosed as COPD or asthma by their physicians were recruited from 43 primary clinic and had been visiting each primary clinic over one year or more will be provided education of 3 times for one months about disease, inhaler use technics and action plans about exacerbation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed as asthma or COPD
- Patients of over 20 years old
- Patients who agree with voluntary informed consent
- Patients who were prescribed inhaler medication as treatment option
Key exclusion criteria (3 listed)
- Patients who have comorbid disorders which can influence on the study result (e.g. severe cardiac or kidney disease, cancer, transplantation, bronchiectasis, tuberculous destroyed lung)
- Pregnant women
- Patients who refused to participate in the study
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 |
|---|---|---|
| Education3 times systemic education program will be provided to patients were diagnosed as asthma or COPD by their physicians. | Behavioural | educated group |
Primary outcome
Change in CAT score
Time frame: one month
The investigators examined change of quality of life through CAT in patient with COPD.
6 secondary outcomes
Change in ACT score
Time frame: one month
Medical cost
Time frame: one month
Compliance to Medication
Time frame: one month
patients satisfaction score with the education program
Time frame: one month
physicians satisfaction score with the education program
Time frame: one month
the time of acute exacerbation
Time frame: one month
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 12 Jul 2016.
- Background: PubMed 20128887Valero C, Monteagudo M, Llagostera M, Bayona X, Granollers S, Acedo M, Ferro JJ, Rodriguez-Latre L, Almeda J, Munoz L; COPD Group of SAP Baix LLobregat Centre. Evaluation of a combined strategy directed towards health-care professionals and patients with chronic obstructive pulmonary disease (COPD): information and health education feedback for improving clinical monitoring and quality-of-life. BMC Public Health. 2009 Dec 1;9:442. doi: 10.1186/1471-2458-9-442.
- Background: PubMed 27160582Wacker ME, Jorres RA, Karch A, Wilke S, Heinrich J, Karrasch S, Koch A, Schulz H, Watz H, Leidl R, Vogelmeier C, Holle R; COSYCONET-Consortium. Assessing health-related quality of life in COPD: comparing generic and disease-specific instruments with focus on comorbidities. BMC Pulm Med. 2016 May 10;16(1):70. doi: 10.1186/s12890-016-0238-9.
- Background: PubMed 27099544Koblizek V, Novotna B, Zbozinkova Z, Hejduk K. Diagnosing COPD: advances in training and practice - a systematic review. Adv Med Educ Pract. 2016 Apr 4;7:219-31. doi: 10.2147/AMEP.S76976. eCollection 2016.
- Background: PubMed 26988095Leiva-Fernandez J, Vazquez-Alarcon RL, Aguiar-Leiva V, Lobnig-Becerra M, Leiva-Fernandez F, Barnestein-Fonseca P. Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial. Trials. 2016 Mar 17;17(1):144. doi: 10.1186/s13063-016-1269-5.
- Individual participant dataSharing planned: No
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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, M.D 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?
A study testing Education in people with COPD and Asthma, 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 4 inclusion and 3 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 12 Jul 2016. 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?
Change in CAT score (time frame: one month). 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 NCT02827929, which also lists 4 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 12 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.