CompletedNot Applicable

ESM in Functional Dyspepsia

Netherlands72 participantsStarted 2020-05-29

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 b…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in experience sampling method (ESM) scores

Timeframe: 10 times daily, during 1 week

Patient complaint diary

Timeframe: End of day 1, end of day 2, end of day 3, end of day 4, end of day 5, end of day 6, end of day 7

Trial details

NCT IDNCT04204421

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-01

View on ClinicalTrials.gov More Dyspepsia trials