Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880722
• Other study ID #: NL57473.068.16
• Status: Completed
• Start date: October 2016
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 1, 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Grünenthal GmbH

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain scores as measured by the ESM tool.	Momentary measurements.	7 days
Secondary	Abdominal pain scores as measured by the end-of-day diary.	Retrospective measurements with a recall period of one day.	7 days
Secondary	Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.	Retrospective measurements with a recall period of one week.	7 days
Secondary	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
Secondary	Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.		7 days
Secondary	Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.		7 days
Secondary	Psychological symptom scores as measured using the PHQ-9.		7 days
Secondary	Psychological symptom scores as measured using the GAD-7.		7 days
Secondary	Quality of life scores as measured using SF-36.		7 days