Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT02880722
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Study Start: 2016-10
• Status Verified: 2022-05
• Primary Completion: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal pain scores as measured by the ESM tool.	7 days	Momentary measurements.

Secondary Outcome Measures

Name	Time	Method
Abdominal pain scores as measured by the end-of-day diary.	7 days	Retrospective measurements with a recall period of one day.
Symptom scores (other than abdominal pain) as measured using the ESM-tool.	7 days	Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment.
Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.	7 days	Retrospective measurements with a recall period of one week.
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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands