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Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome

NCT02880722 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome

Sponsors & Collaborators

  • Grünenthal GmbH

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Ad A.M. Masclee, MD, PhD · Maastricht University Medical Center

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2022-05-31
Completion
2022-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880722 on ClinicalTrials.gov