Esophagitis, RefluxGERDNCT02049723
Assessment of GERD Knowledge Level Among Patients With it in Korea
An observational study of Esophagitis, Reflux, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Esophagitis, Reflux
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with GERD who visit the secondary or tertiary University hospital for their treatment
Who may be able to join
- Patients who were diagnosed as GERD by doctors
Who cannot join
- Patients without GERD
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeon-Soo Kim
Chuncheon, Gangwon-do, 200-704
About this study
Official title: How Much do Patients With Gastroesophageal Disease Know About Their Own Disease in Korea?
- 1. Research topic: How much do patients with GERD know about their own disease in Korea? (multicenter survey)
- 2. Questionnaires for multicenter survey:
- Questionnaire 1 - include items for basic characteristics of participant patients
- 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
Read the detailed description
Validation process to produce Korean version of GERD knowledge test
- Forward Translation of GERD knowledge test of prof. Jorgen Urnes: through certified translation company
- Expert's review of the forward translated knowledge test : among members of GERD club,
- Pilot survey among nurses and some patients
- Korean Version, provisional
- Backward translation: through certified translation company
- Consultation with Prof. Jorgen Urnes about backward translated knowledge test
- Korean Version, final
- Print and distribution
- Study start
- Conditions
- Esophagitis, Reflux
- Keywords
- Gastroesophageal reflux disease, Knowledge
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with GERD | The knowledge level on GERD among Korean patients with gastroesophageal disease was evaluated by the method of multicenter survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Average score in GERD knowledge test which means GERD knowledge level of the patients
GERD, gastroesophageal reflux disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagitis, RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeonsoo Kim, Chuncheon Sacred Heart Hospital
- Investigators
- Moo In Park, MD, Study director, Professor, Department of Internal Medicine, Kosin University Gospel Hsopital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049723
- Sponsor's protocol ID
- GERDclub2013-97
- Acronym
- GERD
- Status last verified
- Apr 2014
- First submitted
- 27 Jan 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Much do Patients With Gastroesophageal Disease Know About Their Own Disease in Korea?
- ClinicalTrials.gov ID
- NCT02049723
- Acronym / sponsor ID
- GERD / GERDclub2013-97
- Conditions
- Esophagitis, Reflux
- Keywords
- Gastroesophageal reflux disease, Knowledge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 1. Research topic: How much do patients with GERD know about their own disease in Korea? (multicenter survey)
- 2. Questionnaires for multicenter survey:
- Questionnaire 1 - include items for basic characteristics of participant patients
- 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
Detailed description
Validation process to produce Korean version of GERD knowledge test
- Forward Translation of GERD knowledge test of prof. Jorgen Urnes: through certified translation company
- Expert's review of the forward translated knowledge test : among members of GERD club,
- Pilot survey among nurses and some patients
- Korean Version, provisional
- Backward translation: through certified translation company
- Consultation with Prof. Jorgen Urnes about backward translated knowledge test
- Korean Version, final
- Print and distribution
- Study start
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with GERD | – | –The knowledge level on GERD among Korean patients with gastroesophageal disease was evaluated by the method of multicenter survey |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with GERD who visit the secondary or tertiary University hospital for their treatment
Key inclusion criteria (1 listed)
- Patients who were diagnosed as GERD by doctors
Key exclusion criteria (1 listed)
- Patients without GERD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion (%) of patients with GERD who seek more information on GERD which represents the necessity of effective educational programs on the disease in Korea
Time frame: 1 year
GERD. gastroesophageal reflux disease
1 secondary outcome
Average score in GERD knowledge test which means GERD knowledge level of the patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moo In Park, MD study director
Professor, Department of Internal Medicine, Kosin University Gospel Hsopital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagitis, Reflux, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeon Soo Kim, MD (82-33-240-5647, meatus@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of patients with GERD who seek more information on GERD which represents the necessity of effective educational programs on the disease in Korea (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.