Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165022
Status:
COMPLETED
Last Update Posted:
2008-03-31
First Post:
2005-09-12
Brief Title:
Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease GERD Patients in Chinese Population
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease GERD Patients in Chinese Population
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None