Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome

Maastricht University Medical Center184 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

184

Conditions

Irritable Bowel Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

Abdominal pain scores as measured by the ESM tool.

Momentary measurements.

Time frame: 7 days

Secondary Outcomes

Abdominal pain scores as measured by the end-of-day diary.

Retrospective measurements with a recall period of one day.

Time frame: 7 days

Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.

Retrospective measurements with a recall period of one week.

Time frame: 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.

Time frame: 7 days

Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.

Time frame: 7 days

Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.

Time frame: 7 days

Psychological symptom scores as measured using the PHQ-9.

Time frame: 7 days

Psychological symptom scores as measured using the GAD-7.

Time frame: 7 days

Quality of life scores as measured using SF-36.

Time frame: 7 days