ESM in Functional Dyspepsia (MEASuRE-D)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Dyspepsia and Other Specified Disorders of Function of Stomach; Dyspepsia

Treatments: Other: Experience Sampling Method (ESM)

Study type: Interventional

Funder types: Other

Identifiers

NCT04204421

METC 19-077 / NL71810.068.19

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Both patients with functional dyspepsia (36) as healthy controls (36) will be included

Inclusion Criteria for patients with functional dyspepsia:

• A diagnosis of functional dyspepsia according to ROME IV criteria (2):

• One or more of the following:
• Bothersome postprandial fullness
• Bothersome early satiation
• Bothersome epigastric pain
• Bothersome epigastric burning

AND

• No evidence of structural disease (confirmed by upper endoscopy) that is likely to explain the symptoms.

• Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.

  • Age between 18 and 75 years;
  • Ability to understand and speak the Dutch language;
  • Ability to understand how to utilize the ESM tool.

Inclusion criteria for healthy volunteers:

• Age between 18 and 75 years
• Ability to understand and speak the Dutch language
• Ability to understand how to utilize the ESM tool.

Exclusion Criteria for patients with functional dyspepsia:

• Any organic explanation for the gastrointestinal complaints;
• Initiation of regularly used medication from one month before inclusion until the end of study participation;
• A history of upper digestive surgery influencing end points
• A history of radiation therapy of the abdomen
• Pregnancy

Exclusion Criteria for healthy controls:

• Current diagnosis of any gastrointestinal disorder
• Current gastrointestinal symptoms suiting the ROME IV criteria for FD
• Initiation of regularly used medication from one month before inclusion until the end of study participation
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Experience Sampling Method (ESM)

Experimental group

Description:

Both patients with functional dyspepsia and healthy controls will be asked to fill out ESM questionnaires during 1 week. Moreover, at the end of this week, usual questionnaires for complaints assessment will be filled out.

Treatment:

Other: Experience Sampling Method (ESM)