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)

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229ER
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

IBS patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IBS patients; IBS according to Rome IV criteria.
Healthy control group; Healthy volunteers without abdominal complaints fulfilling Rome IV criteria for IBS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal pain scores as measured by the ESM tool.	Momentary measurements.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal pain scores as measured by the end-of-day diary.	Retrospective measurements with a recall period of one day.	7 days
Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.	Retrospective measurements with a recall period of one week.	7 days
Symptom scores (other than abdominal pain) as measured using the ESM-tool.	Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment.	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
Psychological symptom scores as measured using the PHQ-9.		7 days
Psychological symptom scores as measured using the GAD-7.		7 days
Quality of life scores as measured using SF-36.		7 days

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Grünenthal GmbH
• Investigators: Principal Investigator: Ad A.M. Masclee, MD, PhD, Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (ESTIMATE): August 26, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Abdominal pain; Irritable Bowel Syndrome (IBS); Ecological Momentary Assessment (EMA); Experience Sampling Method (ESM)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: NL57473.068.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED