Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population - Tabular View

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Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population

This study has been completed.

Study NCT00165022. Last updated on March 27, 2008. Information provided by Chinese University of Hong Kong

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population

Official Title ^†

Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population

Brief Summary

A questionnaire composed of items addressing psychological, emotional and social aspects of GERD is developed for Chinese population. We plan to conduct a validation study on this novel disease-specific quality of life (QoL) instrument. This study aims to evaluate various indicators of validity and reliability, which include criterion validity, test-retest reliability, responsiveness, internal consistency reliability and discriminant validity.

After initial pilot testing of face validity and content validity, two hundred GERD patients from the gastroenterology and ulcer clinics of cluster NTE hospitals will be invited to complete a revised 18-item version of GERD-QOL questionnaire. The data from GERD QOL will be evaluated using exploratory factor analysis to identify appropriate items and domains and the internal consistency of the domains will be determined and further refinement of questionnaire will follow.

100 GERD patients will complete GERD-QOL, SF-36 health survey and the visual analog scale (VAS) questionnaire for criterion validation. 100 GERD patients with stable symptom profile will repeat GERD QOL two weeks after the first administration for evaluation of test-retest reliability.

Another 26 patients who are receiving maintenance acid suppressive therapy and in remission of symptom will be recruited as controls for comparison with active reflux patients. The ability to distinguish active patients from controls in remission is known as discriminant validity.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Cross-Sectional

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Gastroesophageal Reflux Disease

Intervention ^†

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

330

Start Date ^†

September 2003

Completion Date

October 2006

Eligibility Criteria ^†

Inclusion Criteria:

Patients presenting with 1 attack of heartburn and/or acid regurgitation per week as chief complaint in recent 6 months

Exclusion Criteria:Patients with

GERD as GI involvement of systemic disease e.g. scleroderma, SLE, thyrotoxicosis, chronic intestinal pseudo-obstruction
Cause of esophagitis other than GERD e.g. drug induced, infection, nasogastric tube injury
Previous gastrointestinal or hepatobiliary surgery (including cholecystectomy)
Organic pathology of upper GI tract that may present as reflux / dyspeptic symptom e.g. peptic ulcer, gastric cancer, gastric outlet obstruction
Presence of alarm symptom that does not suggest functional GI disorder
Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed)
Pregnant woman or lactating female
Illiterate patient (who cannot administer questionnaire)
Known hypersensitivity to PPI

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

China

Administrative Information Fields

NCT ID ^†

NCT00165022

Organization ID

GQOL

Secondary IDs ^††

Study Sponsor ^†

Chinese University of Hong Kong

Collaborators ^††

Investigators ^†

Principal Investigator:

Justin CY WU, MD

Chinese University of Hong Kong

Information Provided By

Chinese University of Hong Kong

Verification Date

March 2008

First Received Date ^†

September 12, 2005

Last Updated Date

March 27, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.