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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02880722

Enrollment

184

Registered

2016-08-26

Start date

2016-10-31

Completion date

2022-05-01

Last updated

2022-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome (IBS), Experience Sampling Method (ESM), Ecological Momentary Assessment (EMA), Abdominal pain

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.	7 days	Retrospective measurements with a recall period of one week.
Symptom scores (other than abdominal pain) as measured using the ESM-tool.	7 days	Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment.
Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.	7 days	—
Abdominal pain scores as measured by the end-of-day diary.	7 days	Retrospective measurements with a recall period of one day.
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	—
Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.	7 days	—

Countries

Netherlands

Outcome results