ESM in Functional Dyspepsia
- Conditions
- DyspepsiaDyspepsia and Other Specified Disorders of Function of Stomach
- Interventions
- Other: Experience Sampling Method (ESM)
- Registration Number
- NCT04204421
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experience Sampling Method (ESM) 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.
- Primary Outcome Measures
Name Time Method Change in experience sampling method (ESM) scores 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 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 Outcome Measures
Name Time Method Questionnaire for demographic characteristics On day 7 A questionnaire for demographic characteristics will be filled in by participants.
PAGI-SYM questionnaire 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.
NDI questionnaire 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.GSRS questionnaire 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.
PHQ-9 questionnaire 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.
GAD-7 questionnaire 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.
PHQ-15 questionnaire 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.
SF-36 questionnaire 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
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands