Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome

Study Overview
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Brief Summary
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Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently 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. Aim of this study is to validate an IBS-specific electronic patient-reported outcome measure, based on the Experience Sampling Method-principle, for symptom assessment in IBS.

Official Title
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Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)

Conditions
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Irritable Bowel Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of irritable bowel syndrome according to Rome IV criteria. Ability to understand and speak the national language of the concerning center. Ability to understand how to utilize the ESM-tool. Exclusion Criteria: Any organic explanation for the abdominal complaints. A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy. Start up of regularly used medication from one month before inclusion until the end of study participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBS patients<br>IBS according to Rome IV criteria. | |
| Healthy control group<br>Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain scores as measured by the ESM tool. | Momentary measurements. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain scores as measured by the end-of-day diary. | Retrospective measurements with a recall period of one day. | 7 days | 
| Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS. | Retrospective measurements with a recall period of one week. | 7 days | 
| Symptom scores (other than abdominal pain) as measured using the ESM-tool. | Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment. | 7 days | 
| Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary. |  | 7 days | 
| Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS. |  | 7 days | 
| Psychological symptom scores as measured using the PHQ-9. |  | 7 days | 
| Psychological symptom scores as measured using the GAD-7. |  | 7 days | 
| Quality of life scores as measured using SF-36. |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome (IBS), Experience Sampling Method (ESM), Ecological Momentary Assessment (EMA), Abdominal pain