Clinical trial NCT04204421: ESM in Functional Dyspepsia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Dyspepsia and Other Specified Disorders of Function of Stomach
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in experience sampling method (ESM) scores
timeFrame: 10 times daily, during 1 week
measure: 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
Secondary outcomes:
measure: Questionnaire for demographic characteristics
timeFrame: On day 7
measure: PAGI-SYM questionnaire
timeFrame: On day 7
measure: NDI questionnaire
timeFrame: On day 7
measure: GSRS questionnaire
timeFrame: On day 7
measure: PHQ-9 questionnaire
timeFrame: On day 7
measure: GAD-7 questionnaire
timeFrame: On day 7
measure: PHQ-15 questionnaire
timeFrame: On day 7
measure: SF-36 questionnaire
timeFrame: On day 7
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Adrian Masclee, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.