Gastroesophageal Reflux Disease in the Dutch Population

Gastro Esophageal Reflux Clinical Trial

— REFLUX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05689918
• Other study ID #: 2022-13720
• Status: Active, not recruiting
• Start date: December 7, 2022
• Est. completion date: May 7, 2023

Study information

• Verified date: November 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4719
• Est. completion date: May 7, 2023
• Est. primary completion date: March 7, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia)	The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.	7 days
Primary	Level of awareness of esophageal cancer risk factors and alarm symptoms	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	Number of individuals that sought help for GERD (general practitioner/referral)	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
Secondary	Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed)	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
Secondary	Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter)	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
Secondary	Beliefs about esophageal cancer	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