Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI: PASS-HK

September 20, 2018 updated by: Justin Che-Yuen Wu, Chinese University of Hong Kong

Translation and Validation of the PASS Test for Gastro-esophageal Reflux Disease (GERD) Patients With Partial Response to PPI in Chinese Population: PASS-HK

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.

Study Overview

Status

Unknown

Conditions

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 9.3% 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 Cronbach's 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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Justin CY Wu, MBChB(CUHK)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject has been taking any PPI and still has persistent GERD symptoms during PPI therapy

Description

Inclusion Criteria:

  • Able to give study informed consent
  • Male or female. Age 18 or above
  • Have at least 6 months history of GERD symptoms (need not to be consecutive) as chief complaint, e.g. acid regurgitation or heartburn
  • Subject has been taking any PPI at standard dose for at least 8 weeks Subject has persistent symptoms during PPI therapy with GERDQ score ≥8
  • An upper gastrointestinal endoscopy is required within the past 1 year to confirm the absence of mucosal breaks, peptic ulcer and other GI diseases e.g. gastric outlet obstruction

Exclusion Criteria:

  • Patients that have not experienced any GERD symptom improvement at all during PPI treatment
  • Unstable or clinically significant cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric, other clinical disorders, or gastrointestinal and esophageal disorders besides GERD. Clinically significant is defined as disorders that could compromise patients' safety or interfere with the evaluation of the study as judged by the investigator.
  • History of or current malignant disease
  • Subject is pregnant or lactating
  • Prior surgery of the upper GI tract (open, endoscopic and laparoscopic surgery on the esophagus, the stomach and the duodenum)
  • Illiterate patient (who cannot administer questionnaire)
  • Known hypersensitivity to any PPI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASS_C questionnaire
Time Frame: One year
the reliability of PASS-HK will be evaluated for internal consistency using Cronbach's alpha. The intraclass correlation coefficient will be calculated within 14 days for two surveys in order to evaluate the reproducibility of the results under constant conditions.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Justin C.Y. Wu, MBChB(CUHK), Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PASS-HK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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