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

NCT00165022 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2008-03-31

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Justin CY WU, MD · Chinese University of Hong Kong

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Completion
2006-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00165022 on ClinicalTrials.gov