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Efficacy of Education Programs in Patients With Chronic Airway Diseases

Primary Purpose

COPD, Asthma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Education
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COPD

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Konkuk University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

educated group

Arm Description

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

Outcomes

Primary Outcome Measures

Change in CAT score
The investigators examined change of quality of life through CAT in patient with COPD.

Secondary Outcome Measures

Change in ACT score
The investigators examined change of quality of life through Asthma control test in patient with asthma.
Medical cost
The investigators will compare the total medical cost related COPD or asthma before education with that after education. (unit: Korean won, KRW)
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
patients satisfaction score with the education program
physicians satisfaction score with the education program
the time of acute exacerbation

Full Information

First Posted
June 29, 2016
Last Updated
July 10, 2016
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02827929
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
educated group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
3 times systemic education program will be provided to patients were diagnosed as asthma or COPD by their physicians.
Primary Outcome Measure Information:
Title
Change in CAT score
Description
The investigators examined change of quality of life through CAT in patient with COPD.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Change in ACT score
Description
The investigators examined change of quality of life through Asthma control test in patient with asthma.
Time Frame
one month
Title
Medical cost
Description
The investigators will compare the total medical cost related COPD or asthma before education with that after education. (unit: Korean won, KRW)
Time Frame
one month
Title
Compliance to Medication
Description
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
Time Frame
one month
Title
patients satisfaction score with the education program
Time Frame
one month
Title
physicians satisfaction score with the education program
Time Frame
one month
Title
the time of acute exacerbation
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwang-Ha NA Yoo, M.D
Organizational Affiliation
Konkuk University Hospial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Hospital
City
Gwangjin-gu
State/Province
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20128887
Citation
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.
Results Reference
background
PubMed Identifier
27160582
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.
Results Reference
background
PubMed Identifier
27099544
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.
Results Reference
background
PubMed Identifier
26988095
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.
Results Reference
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Efficacy of Education Programs in Patients With Chronic Airway Diseases

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