ESM in Functional Dyspepsia

NCT ID: NCT04204421

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-29
• Study Completion Date: 2020-10-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experience Sampling Method (ESM)

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.

Group Type: EXPERIMENTAL

Experience Sampling Method (ESM)

Intervention Type: 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.

Interventions

Experience Sampling Method (ESM)

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.

Intervention Type: OTHER

Other Intervention Names

ESM

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Masclee, Prof.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 34524263 (View on PubMed)

Other Identifiers

METC 19-077 / NL71810.068.19

Identifier Type: -

Identifier Source: org_study_id