Gastroesophageal Reflux Disease in the Dutch Population (REFLUX)

January 16, 2023 updated by: Radboud University Medical Center

Gastroesophageal Reflux Symptoms and Help-seeking Behavior, Medication Use and Esophageal Cancer Awareness: Dutch Population-based Survey

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.

Study Overview

Status

Active, not recruiting

Conditions

Gastro Esophageal Reflux

Intervention / Treatment

Other: No intervention

Study Type

Observational

Enrollment (Anticipated)

4719

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

Netherlands
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6525GA
    - Radboudumc

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Dutch population registry, 'Basisregistratie Personen' (BRP).

Description

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.

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: Other
Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia) Time Frame: 7 days	The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.	7 days
Level of awareness of esophageal cancer risk factors and alarm symptoms Time Frame: Baseline	The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The alarm symptom module measures whether participants think dysphagia, change in stool pattern, change in appearance of a mole, weightloss and palpable lesions are alarm symptoms of cancer (yes/no/don't know). The risk factor module measures whether participants think alcohol, smoking, obesity, male sex, GERD symptoms, age>50y, familial esophageal cancer, hot drinks and radiation are risk factors for esophageal cancer on a 4 point scale (strongly disagree - strongly agree).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of individuals that sought help for GERD (general practitioner/referral) Time Frame: 20 years	Participants with GERD will be asked whether they discussed their symptoms with their GP, whether they have been referred to a gastroenterologist or internist and what their reasons were for seeking help or not seeking help (answer options were based on qualitative research).	20 years
Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed) Time Frame: 6 months	Participants will be asked to indicate whether they used prescribed Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.	6 months
Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter) Time Frame: 6 months	Participants will be asked to indicate whether they used over-the-counter Omeprazol, Pantoprazol, Esomeprazol, Lansoprazol, Rabeprazol, Cimetidine, Famotidine, Nizatidine, Ranitidine, Sucralfate, Misoprostol, Antagel, Gastilox, Maalox, Gaviscon, Regla-pH, Rennie, Magnesiumhydroxide, Iberogast or A. Vogel Boldocynara in the past 6 months.	6 months
Beliefs about esophageal cancer Time Frame: Baseline	The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The beliefs module measures whether participants think esophageal cancer can be treated, can be cured, is a death sentence, can benefit from early detection and whether they would wish to know about de diagnosis on a 4 point Likerts scale (strongly disagree - strongly agree).	Baseline

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

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)

December 7, 2022

Primary Completion (Anticipated)

March 7, 2023

Study Completion (Anticipated)

May 7, 2023

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)