NCT02827929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

June 29, 2016

Last Update Submit

July 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in CAT score

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

    one month

Secondary Outcomes (6)

  • Change in ACT score

    one month

  • Medical cost

    one month

  • Compliance to Medication

    one month

  • patients satisfaction score with the education program

    one month

  • physicians satisfaction score with the education program

    one month

  • +1 more secondary outcomes

Study Arms (1)

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

Behavioral: Education

Interventions

EducationBEHAVIORAL

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

educated group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Hospital

Gwangjin-gu, Seoul, 05030, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 20128887BACKGROUND
  • 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.

    PMID: 27160582BACKGROUND
  • 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.

    PMID: 27099544BACKGROUND
  • 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.

    PMID: 26988095BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Kwang-Ha NA Yoo, M.D

    Konkuk University Hospial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 11, 2016

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

March 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations