ESM in Functional Dyspepsia

NCT04204421 | Completed

• 1 other identifier: METC 19-077 / NL71810.068.19
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in experience sampling method (ESM) scores

  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.

  10 times daily, during 1 week

• Patient complaint diary

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

  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

Secondary Outcomes (8)

• Questionnaire for demographic characteristics

  On day 7

• PAGI-SYM questionnaire

  On day 7

• NDI questionnaire

  On day 7

• GSRS questionnaire

  On day 7

• PHQ-9 questionnaire

  On day 7

Study Arms (1)

Experience Sampling Method (ESM)

EXPERIMENTAL

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.

Other: Experience Sampling Method (ESM)

Interventions

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.

Also known as: ESM

Experience Sampling Method (ESM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any organic explanation for the gastrointestinal complaints;
• A history of upper digestive surgery influencing end points
• A history of radiation therapy of the abdomen
• Pregnancy
• Current diagnosis of any gastrointestinal disorder
• Current gastrointestinal symptoms suiting the ROME IV criteria for FD
• Pregnancy

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229HX, Netherlands

Location

Related Publications (1)

• Klaassen T, Vork L, Smeets FGM, Troost FJ, Kruimel JW, Leue C, Masclee AAM, Keszthelyi D. The Interplay Between Stress and Fullness in Patients With Functional Dyspepsia and Healthy Controls: An Exploratory Experience Sampling Method Study. Psychosom Med. 2022 Apr 1;84(3):306-312. doi: 10.1097/PSY.0000000000001012.

  PMID: 34524263 DERIVED

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Masclee, Prof.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 19, 2019
• Study Start: May 29, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)