Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2022-05-01

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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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IBS patients

IBS according to Rome IV criteria.

No interventions assigned to this group

Healthy control group

Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS.

No interventions assigned to this group

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes