Clinical trial NCT05689918: Gastroesophageal Reflux Disease in the Dutch Population
Official title: Gastroesophageal Reflux Symptoms and Help-seeking Behavior, Medication Use and Esophageal Cancer Awareness: Dutch Population-based Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastro Esophageal Reflux
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 4719
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Dutch population registry, 'Basisregistratie Personen' (BRP).

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia)
timeFrame: 7 days
measure: Level of awareness of esophageal cancer risk factors and alarm symptoms
timeFrame: Baseline
Secondary outcomes:
measure: Number of individuals that sought help for GERD (general practitioner/referral)
timeFrame: 20 years
measure: Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed)
timeFrame: 6 months
measure: Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter)
timeFrame: 6 months
measure: Beliefs about esophageal cancer
timeFrame: Baseline
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: