Efficacy of Education Programs in Patients With Chronic Airway Diseases

Asthma Clinical Trial

Official title:

Efficacy of Education Programs in Patients With Chronic Airway Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827929
• Other study ID #: ESR-14-10193
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: July 10, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical 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. An organized education on the chronic airway disease is directed by primary care physicians, and the investigators evaluate the effectiveness of the education.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Education
3 times systemic education program will be provided to patients were diagnosed as asthma or COPD by their physicians.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. Review. — View Citation

Leiva-Fernández J, Vázquez-Alarcón RL, Aguiar-Leiva V, Lobnig-Becerra M, Leiva-Fernández 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. — View Citation

Valero C, Monteagudo M, Llagostera M, Bayona X, Granollers S, Acedo M, Ferro JJ, Rodríguez-Latre L, Almeda J, Muñoz 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. — View Citation

Wacker ME, Jörres 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CAT score	The investigators examined change of quality of life through CAT in patient with COPD.	one month	No
Secondary	Change in ACT score	The investigators examined change of quality of life through Asthma control test in patient with asthma.	one month	No
Secondary	Medical cost	The investigators will compare the total medical cost related COPD or asthma before education with that after education. (unit: Korean won, KRW)	one month	No
Secondary	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	one month	No
Secondary	patients satisfaction score with the education program		one month	No
Secondary	physicians satisfaction score with the education program		one month	No
Secondary	the time of acute exacerbation		one month	No