Efficacy of Education Programs in Patients With Chronic Airway Diseases

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.

Study Overview

• Status: Completed
• Conditions: Asthma; COPD
• Intervention / Treatment: Behavioral: 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 Type: Interventional
• Enrollment (Actual): 285
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Gwangjin-gu, Seoul, Korea, Republic of, 05030
      • Konkuk University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: educated group; 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	Behavioral: Education; 3 times systemic education program will be provided to patients were diagnosed as asthma or COPD by their physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CAT score	The investigators examined change of quality of life through CAT in patient with COPD.	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ACT score	The investigators examined change of quality of life through Asthma control test in patient with asthma.	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)	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	one month
patients satisfaction score with the education program		one month
physicians satisfaction score with the education program		one month
the time of acute exacerbation		one month

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Kwang-Ha NA Yoo, M.D, Konkuk University Hospial

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 10, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ESR-14-10193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO