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Trial Title:
Gastroesophageal Reflux Disease in the Dutch Population
NCT ID:
NCT05689918
Condition:
Gastro Esophageal Reflux
Conditions: Official terms:
Gastroesophageal Reflux
Study type:
Observational [Patient Registry]
Overall status:
Unknown status
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
No intervention
Summary:
Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may
help to decrease mortality of this malignancy. To understand the size of the target
population for potential EAC screening, insight in the prevalence of registered and
unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed.
Insight in public awareness of EAC will provide additional useful information for public
communication strategies.
Objective: The aims of this study are to assess the prevalence of GERD symptoms and
related help-seeking behavior, registered and unregistered medication use and awareness
of esophageal cancer in the general Dutch population.
Study design: Cross-sectional population-based survey.
Study population: Dutch citizens aged 18-75 years.
Methods: Eligible individuals will be selected from the Dutch population registry (BRP)
using simple random sampling. Invitations will be sent by postal mail with participants
being directed to a digital survey.
Main study parameters/endpoints: The outcome variables are presence of current GERD
symptoms, number of GERD patients that consulted a doctor, number of GERD patients using
prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs)
and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The
association between socio-demographic background and outcome variables will also be
evaluated.
Nature and extent of the burden and risks associated with participation, benefit and
group relatedness: Subjects will not directly benefit from participating in this study.
Nonetheless, participating in this study is not associated with any healthcare risks and
the burden for the subjects is very low. The survey has a low burdensome nature and will
take approximately 20 minutes to complete. All data will be pseudonymized, refusal to
fill out the survey or desire to withdraw from the study will not have any consequences
for the invited subject.
Criteria for eligibility:
Study pop:
Dutch population registry, 'Basisregistratie Personen' (BRP).
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Age 18 - 75 years
Exclusion Criteria:
- Unable to provide informed consent for any reason;
- Unable to fill out the digital survey for any reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6525GA
Country:
Netherlands
Start date:
December 7, 2022
Completion date:
May 7, 2023
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05689918
