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ESM in Functional Dyspepsia

NCT04204421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-10-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Adrian Masclee, Prof. · Maastricht University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204421 on ClinicalTrials.gov