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Completed

NCT Number: NCT04204421

ESM in Functional Dyspepsia

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.

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Key information

Conditions

Dyspepsia Dyspepsia and Other Specified Disorders of Function of Stomach Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experience Sampling Method (ESM)

Other

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.

Other names: ESM

Primary outcomes

  1. Change in experience sampling method (ESM) scores

    Time frame: 10 times daily, during 1 week

    Using the MEASuRE-D app, the same ESM questionnaire will be filled in 10 times per day at random intervals. This results in a lot of real-time data on patient symptom scores on which changes over the course of the day can be seen.

  2. Patient complaint diary

    Time frame: 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

    Using the MEASuRE-D app, patients will fill out a complaints diary at the end of each day during 7 days

Secondary outcomes

  1. Questionnaire for demographic characteristics

    Time frame: On day 7

    A questionnaire for demographic characteristics will be filled in by participants.

  2. PAGI-SYM questionnaire

    Time frame: On day 7

    the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity index (PAGI-SYM) questionnaire will be filled in by participants. Questions about upper gastrointestinal symptoms are asked on a 6 point likert scale with 0 indicating not at all and 5 indicating very severe.

  3. NDI questionnaire

    Time frame: On day 7

    The Nepean Dyspepsia Index (NDI) questionnaire will be filled in by participants. The NDI questionaire consists of various questions.

    Questions about the effects of upper gastrointestinal symptoms are asked on a 5 point likert scale with 1 indicating not at all/almost never and 5 indicating very severe/always.

  4. GSRS questionnaire

    Time frame: On day 7

    The Gastrointestinal Symptom Rating Scale (GSRS) will be filled in by participants. Questions about gastrointestinal symptoms are asked on a 7 point likert scale with 0 indicating not at all and 6 indicating very severe.

  5. PHQ-9 questionnaire

    Time frame: On day 7

    The Patient Health Questionnaire-9 (PHQ-9) will be filled in by participants. Questions about the severity of depressive symptoms are asked on a scale from 0 - 3, where 0 indicates not at all, 1 indicates some days, 2 indicates more than half of the days, and 3 indicates almost every day.

  6. GAD-7 questionnaire

    Time frame: On day 7

    The Generalized Anxiety Disorder-7 (GAD-7) questionnaire will be filled in by participants. Questions about the severity of anxiety symptoms are asked on a scale from 0 - 3, where 0 indicates not at all, 1 indicates some days, 2 indicates more than half of the days, and 3 indicates almost every day.

  7. PHQ-15 questionnaire

    Time frame: On day 7

    The Patient Health Questionnaire-15 (PHQ-15) will be filled in by participants. Questions about somatization symptoms are asked in the following matter: how often have you been bothered by "..." on a scale from 0 - 2, where 0 indicates not at all, 1 indicates bothered a little, and 2 indicates bothered a lot.

  8. SF-36 questionnaire

    Time frame: On day 7

    The Short Form-36 (SF-36) questionnaire will be filled in by participants and consits of various types of questions.

    Some questions about how their health limits them in certain daily activities are asked on a scale of 1-3, with 1 indicating limits severely, 2 indicating limits a little, and 3 indicating not limited at all Some questions about problems in participants' work or daily activities due to physical health, emotional problems are dichotomous with 1 indicating yes and 2 indicating no Some questions about how participants felt themselves during a period are asked on a 6 point scale with 1 indicating all the time, 2 indicating most of the time, 3 indicating often, 4 indicating sometimes, 5 indicating occasionally, and 6 indicating not at all Participants need to indicate how much a few statements apply to them with 1 indicating completely correct, 2 indicating mostly correct, 3 indicating I don't know, 4 indicating mostly incorrect, and 5 indicating completely correct

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study 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

Acronym: MEASuRE-D

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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