NCT04204421

ESM in Functional Dyspepsia

The Experience Sampling Method (ESM): Validation of a Newly Developed Real-time Patient-Reported Outcome Measure (PROM) and Its Evaluation of Triggers for Functional Dyspepsia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Background: Reliable patient reported outcome measures (PROM's) for symptom assessment in functional dyspepsia (FD) are essential in order to evaluate dyspeptic symptoms, identify potential symptom triggers and optimize therapeutic strategies, since biological markers are unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia. Objective: The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia. In order to measure this, internal consistency, test-retest reliability, concurrent validity and the accuracy to differentiate between dyspeptic patients and healthy controls of the developed ePRO will be assessed. In addition, to objectify specific triggers for the onset of gastrointestinal symptoms in dyspepsia, using the FD-specific ESM tool.

Conditions

• Dyspepsia
• Dyspepsia and Other Specified Disorders of Function of Stomach

Interventions

Type	Name	Description
OTHER	Experience Sampling Method (ESM)	Experience Sampling Method (ESM) is a method for real time complaints assessment where people are asked to fill out a questionnaire 10 times per day at random moments. This will be done via a mobile phone application.

Timeline

• Start date: 2020-05-29
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2019-12-19
• Last updated: 2020-10-08

Locations

1 site across 1 country: Netherlands