NCT04204421: MEASuRE-D

ESM in Functional Dyspepsia

Completed NA Last updated 8 October 2020

What this trial tests

NA trial testing Experience Sampling Method (ESM) in Dyspepsia in 72 participants. Completed in 1 October 2020.

Timeline

29 May 2020

Primary endpoint
1 October 2020

1 October 2020

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	72
Start date	29 May 2020
Primary completion	1 October 2020
Estimated completion	1 October 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Experience Sampling Method (ESM)

Conditions studied

• Dyspepsia — all drugs for Dyspepsia →
• Dyspepsia and Other Specified Disorders of Function of Stomach — all drugs for Dyspepsia and Other Specified Disorders of Function of Stomach →

Sponsor

Maastricht University Medical Center

Who can join

Adults 18 to 75, any sex, with Dyspepsia or Dyspepsia and Other Specified Disorders of Function of Stomach. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychometric evaluation of an experience sampling method-based patient-reported outcome measure in functional dyspepsia.
   Klaassen T, Smeets FGM, Vork L, Tack J, et al · · 2021 · cited 9× · PMID 33934444 · DOI 10.1111/nmo.14136
2. The Interplay Between Stress and Fullness in Patients With Functional Dyspepsia and Healthy Controls: An Exploratory Experience Sampling Method Study.
   Klaassen T, Vork L, Smeets FGM, Troost FJ, et al · · 2022 · cited 8× · PMID 34524263 · DOI 10.1097/psy.0000000000001012
3. Digital Instruments for Reporting of Gastrointestinal Symptoms in Clinical Trials: Comparison of End-of-Day Diaries Versus the Experience Sampling Method.
   Beckers AB, Snijkers JTW, Weerts ZZRM, Vork L, et al · · 2021 · cited 2× · PMID 34821561 · DOI 10.2196/31678