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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.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00165022
First received: September 12, 2005
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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.


Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Enrollment: 330
Study Start Date: September 2003
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165022

Locations
China
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Justin CY WU, MD Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00165022     History of Changes
Other Study ID Numbers: GQOL
Study First Received: September 12, 2005
Last Updated: March 27, 2008
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014