Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome
Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)
1 other identifier
observational
184
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 26, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMay 19, 2022
May 1, 2022
5.6 years
July 28, 2016
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abdominal pain scores as measured by the ESM tool.
Momentary measurements.
7 days
Secondary Outcomes (8)
Abdominal pain scores as measured by the end-of-day diary.
7 days
Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.
7 days
Symptom scores (other than abdominal pain) as measured using the ESM-tool.
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
- +3 more secondary outcomes
Study Arms (2)
IBS patients
IBS according to Rome IV criteria.
Healthy control group
Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS.
Eligibility Criteria
IBS patients.
You may qualify if:
- 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.
You may not qualify if:
- Any organic explanation for the abdominal complaints.
- A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Grünenthal GmbHcollaborator
Study Sites (1)
Maastricht University Medical Center
Maastricht, 6229ER, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ad A.M. Masclee, MD, PhD
Maastricht University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 26, 2016
Study Start
October 1, 2016
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
May 19, 2022
Record last verified: 2022-05