Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02437682
Status:
UNKNOWN
Last Update Posted:
2018-09-24
First Post:
2015-05-05
Brief Title:
Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI PASS-HK
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Translation and Validation of the PASS Test for Gastro-esophageal Reflux Disease GERD Patients With Partial Response to PPI in Chinese Population PASS-HK
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
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:
The PASS test is only available and valid tool for the evaluation of persistent acid-related symptoms in patients receiving PPI therapy There is lack of a validated Chines version of PASS questionnaire for the GERD patients with partial response to proton pump inhibitor PPI The English version of PASS test will be translated to traditional Chinese by using forward-backward procedure and the Chinese version of PASS test will be validated its psychometric properties in Hong Kong population
Eligible subjects will be invited to administer questionnaires to evaluate the psychometric properties of the Chinese version of PASS test
Eligible subjects will be invited to administer questionnaires to evaluate the psychometric properties of the Chinese version of PASS test
Detailed Description:
Gastro-esophageal reflux disease GERD is a common condition defined as symptoms or mucosal damage produced by the abnormal reflux of gastric contents into the esophagus Symptoms highly specific for GERD are heartburn regurgitation or both which often occur after meals The prevalence of GERD is around 20 for weekly reflux symptoms in the Western population while 93 in Chinese population However approximately 20-30 of patients with GERD experience only a partial response of their heartburn of regurgitation symptoms to PPI therapy
There is lack of a validated Chines version of PASS questionnaire for the GERD patients with partial response to PPI
Before a treatment response assessment tool can be used clinically various questions on reliability and validity of the instrument need to be addressed The aims of this study are 1 to translate the PASS test from English to traditional Chinese named PASS-HK and 2 to assess the psychometric properties of the PASS-HK before clinical application
Linguistic translation of the PASS questionnaire from English to Chinese version will follow a forward-backward procedure
After finalization of Chinese version of the PASS PASS-HK the reliability of PASS-HK will be evaluated for internal consistency using Cronbachs alpha The intraclass correlation coefficient was calculated within 14 days for two surveys in order to evaluate the reproducibility of the results under constant conditions Pearson product moment correlation coefficient will be used to evaluate whether PASS-HK can measure what it claims to measure by comparing with SF-12v2 GERD QOL and GREDSQ scores
All eligible subjects will be invited to complete PASS-HK twice within 14 days under a stable condition In addition to PASS-HK all patients will have to complete SF-12v2 GERD-QOL GERDQ and GERDSQ questionnaires
There is lack of a validated Chines version of PASS questionnaire for the GERD patients with partial response to PPI
Before a treatment response assessment tool can be used clinically various questions on reliability and validity of the instrument need to be addressed The aims of this study are 1 to translate the PASS test from English to traditional Chinese named PASS-HK and 2 to assess the psychometric properties of the PASS-HK before clinical application
Linguistic translation of the PASS questionnaire from English to Chinese version will follow a forward-backward procedure
After finalization of Chinese version of the PASS PASS-HK the reliability of PASS-HK will be evaluated for internal consistency using Cronbachs alpha The intraclass correlation coefficient was calculated within 14 days for two surveys in order to evaluate the reproducibility of the results under constant conditions Pearson product moment correlation coefficient will be used to evaluate whether PASS-HK can measure what it claims to measure by comparing with SF-12v2 GERD QOL and GREDSQ scores
All eligible subjects will be invited to complete PASS-HK twice within 14 days under a stable condition In addition to PASS-HK all patients will have to complete SF-12v2 GERD-QOL GERDQ and GERDSQ questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None