Full Text View
Tabular View
No Study Results Posted
Related Studies
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   Information provided by Chinese University of Hong Kong
First Received: September 12, 2005   Last Updated: March 27, 2008   History of Changes

September 12, 2005
March 27, 2008
September 2003
 
 
 
Complete list of historical versions of study NCT00165022 on ClinicalTrials.gov Archive Site
 
 
 
Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population
Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population

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.

 
 
Observational
Cohort, Cross-Sectional
Gastroesophageal Reflux Disease
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
330
October 2006
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00165022
 
GQOL
Chinese University of Hong Kong
 
Principal Investigator: Justin CY WU, MD Chinese University of Hong Kong
Chinese University of Hong Kong
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP