Clinical trial NCT02827929: Efficacy of Education Programs in Patients With Chronic Airway Diseases
Official title: Efficacy of Education Programs in Patients With Chronic Airway Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Asthma
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 285
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed as asthma or COPD
2. Patients of over 20 years old
3. Patients who agree with voluntary informed consent
4. Patients who were prescribed inhaler medication as treatment option

Exclusion Criteria:

1. 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)
2. Pregnant women
3. Patients who refused to participate in the study

Primary outcomes:
measure: Change in CAT score
timeFrame: one month
Secondary outcomes:
measure: Change in ACT score
timeFrame: one month
measure: Medical cost
timeFrame: one month
measure: Compliance to Medication
timeFrame: one month
measure: patients satisfaction score with the education program
timeFrame: one month
measure: physicians satisfaction score with the education program
timeFrame: one month
measure: the time of acute exacerbation
timeFrame: one month
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, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wacker 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.
citation: Koblizek 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.
citation: Leiva-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.