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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Change in experience sampling method (ESM) scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
- •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
Arms & Interventions
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.
Intervention: Experience Sampling Method (ESM) (Other)
Outcomes
Primary Outcomes
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.
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
- 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)
- GAD-7 questionnaire(On day 7)
- PHQ-15 questionnaire(On day 7)
- SF-36 questionnaire(On day 7)