Gastro-esophageal Reflux DiseaseNCT02437682
Translation and Validation of the PASS Test for GERD Patients With Partial Response to PPI: PASS-HK
An observational study of Gastro-esophageal Reflux Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-esophageal Reflux Disease
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Jan 2017to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject has been taking any PPI and still has persistent GERD symptoms during PPI therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Justin CY Wu, MBChB(CUHK), (852)26323476, justinwu@cuhk.edu.hk
Pui Kuan PK Cheong, MPH, (852)26323476, jcheong@cuhk.edu.hk
About this study
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
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.
Read the 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.
- Conditions
- Gastro-esophageal Reflux Disease
- Keywords
- Gastro-esophageal Reflux Disease, Proton pump inhibitor
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
PASS_C questionnaire
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study start11 Jan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Che-Yuen Wu, Chinese University of Hong Kong
- Investigators
- Justin C.Y. Wu, MBChB(CUHK), Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437682
- Sponsor's protocol ID
- PASS-HK
- Status last verified
- Sep 2018
- First submitted
- 5 May 2015
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02437682
- Acronym / sponsor ID
- PASS-HK
- Conditions
- Gastro-esophageal Reflux Disease
- Keywords
- Gastro-esophageal Reflux Disease, Proton pump inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject has been taking any PPI and still has persistent GERD symptoms during PPI therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin C.Y. Wu, MBChB(CUHK) principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-esophageal Reflux Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin C.Y. Wu, MBChB(CUHK) ((852)2632 3855, justinwu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASS_C questionnaire (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.