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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02049723
Other study ID # GERDclub2013-97
Secondary ID
Status Recruiting
Phase N/A
First received January 27, 2014
Last updated April 4, 2014
Start date April 2014
Est. completion date February 2015

Study information

Verified date April 2014
Source Chuncheon Sacred Heart Hospital
Contact Yeon Soo Kim, MD
Phone 82-33-240-5647
Email meatus@naver.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

- 1. Research topic: How much do patients with GERD know about their own disease in Korea? (multicenter survey)

- 2. Questionnaires for multicenter survey:

1. Questionnaire 1 - include items for basic characteristics of participant patients

2. Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health Services Research 2008;8:236 (Prof. Jorgen Urnes)

- 3. Subjects: patients with GERD in secondary or tertiary hospital

- 4. Participant institutes: GERD club members, The Korean Society of Neurogastroenterology and Motility


Description:

Validation process to produce Korean version of GERD knowledge test

1. Forward Translation of GERD knowledge test of prof. Jorgen Urnes: through certified translation company

2. Expert's review of the forward translated knowledge test : among members of GERD club,

3. Pilot survey among nurses and some patients

4. Korean Version, provisional

5. Backward translation: through certified translation company

6. Consultation with Prof. Jorgen Urnes about backward translated knowledge test

7. Korean Version, final

8. Print and distribution

9. Study start


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients who were diagnosed as GERD by doctors

Exclusion Criteria:

- Patients without GERD

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Yeon-Soo Kim Chuncheon Gangwon

Sponsors (1)

Lead Sponsor Collaborator
Chuncheon Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion (%) of patients with GERD who seek more information on GERD which represents the necessity of effective educational programs on the disease in Korea GERD. gastroesophageal reflux disease 1 year No
Secondary Average score in GERD knowledge test which means GERD knowledge level of the patients GERD, gastroesophageal reflux disease 1 year No
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