Assessment of GERD Knowledge Level Among Patients With it... | NCT02049723

Studies
Assessment of GERD Knowledge Level Among Patients With it in Korea

NCT02049723

Sponsor

Chuncheon Sacred Heart Hospital

Status

Unknown status

Last Update Posted

Apr 7, 2014Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Esophagitis, Reflux

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Jan 27, 2014

First Submission Date that Met QC Criteria

Jan 29, 2014

First Posted Date

Jan 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2014

Last Update Posted Date

Apr 7, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yeonsoo Kim, Assistant professor, Chuncheon Sacred Heart HospitalPrincipal Investigator

Lead Sponsor

Chuncheon Sacred Heart HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with GERD		The knowledge level on GERD among Korean patients with gastroesophageal disease was evaluated by the method of multicenter survey

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Average score in GERD knowledge test which means GERD knowledge level of the patients	GERD, gastroesophageal reflux disease	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who were diagnosed as GERD by doctors

Exclusion Criteria:

Patients without GERD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with GERD who visit the secondary or tertiary University hospital for their treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeon Soo Kim, MD	Contact	82-33-240-5647		meatus@naver.com

Overall Officials

Name	Affiliation	Role
Moo In Park, MD	Professor, Department of Internal Medicine, Kosin University Gospel Hsopital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yeon-Soo Kim	Recruiting	Chuncheon	Gangwon-do	200-704	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D004942	Esophagitis, Peptic
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

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