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ESM in Functional Dyspepsia — MEASuRE-D  

Dyspepsia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Dyspepsia
  • Dyspepsia and Other Specified Disorders of Function of Stomach
Clinical Trial Details
NCT number NCT04204421
Study type Interventional
Source Maastricht University Medical Center
Contact
Status Completed
Phase N/A
Start date May 29, 2020
Completion date October 1, 2020
View Details
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