Clinical trial NCT02880722: Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome
Official title: Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome (IBS)
Experience Sampling Method (ESM)
Ecological Momentary Assessment (EMA)
Abdominal pain
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Grünenthal GmbH
First posted: 2016-08-26
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBS patients.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Abdominal pain scores as measured by the ESM tool.
timeFrame: 7 days
Secondary outcomes:
measure: Abdominal pain scores as measured by the end-of-day diary.
timeFrame: 7 days
measure: Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.
timeFrame: 7 days
measure: Symptom scores (other than abdominal pain) as measured using the ESM-tool.
timeFrame: 7 days
measure: Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.
timeFrame: 7 days
measure: Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.
timeFrame: 7 days
measure: Psychological symptom scores as measured using the PHQ-9.
timeFrame: 7 days
measure: Psychological symptom scores as measured using the GAD-7.
timeFrame: 7 days
measure: Quality of life scores as measured using SF-36.
timeFrame: 7 days
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Ad A.M. Masclee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: