Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)
Sponsor study identifier
observational
184
1 country
1
Study Start
October 2016
Actual (reported)Primary Completion
May 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 28, 2016
Actual (reported)August 26, 2016
Actual (reported)October 2016
Actual (reported)May 2022
Actual (reported)May 1, 2022
Actual (reported)Abdominal pain scores as measured by the ESM tool.
Momentary measurements.
7 days
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
IBS according to Rome IV criteria.
Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS.
IBS patients.
Maastricht University Medical Center
Maastricht, 6229ER, Netherlands
Ad A.M. Masclee, MD, PhD
Maastricht University Medical Center
184 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2016
First Posted
August 26, 2016
Study Start
October 2016
Actual (reported)Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)
Contact the study team to confirm eligibility.
Primary Completion
May 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)Last Updated
May 19, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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