Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05689918
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-01-19
First Post:
2022-11-30
Brief Title:
Gastroesophageal Reflux Disease in the Dutch Population
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Gastroesophageal Reflux Symptoms and Help-seeking Behavior Medication Use and Esophageal Cancer Awareness Dutch Population-based Survey
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFLUX
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 parametersendpoints The outcome variables are presence of current GERD symptoms number of GERD patients that consulted a doctor number of GERD patients using prescribed andor 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
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 parametersendpoints The outcome variables are presence of current GERD symptoms number of GERD patients that consulted a doctor number of GERD patients using prescribed andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None