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Completed

NCT Number: NCT02880722

Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Abdominal pain scores as measured by the ESM tool.

    Time frame: 7 days

    Momentary measurements.

Secondary outcomes

  1. Abdominal pain scores as measured by the end-of-day diary.

    Time frame: 7 days

    Retrospective measurements with a recall period of one day.

  2. Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.

    Time frame: 7 days

    Retrospective measurements with a recall period of one week.

  3. Symptom scores (other than abdominal pain) as measured using the ESM-tool.

    Time frame: 7 days

    Gastrointestinal symptoms, psychological symptoms, extra-intestinal symptoms, data on context and environment.

  4. Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.

    Time frame: 7 days

  5. Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.

    Time frame: 7 days

  6. Psychological symptom scores as measured using the PHQ-9.

    Time frame: 7 days

  7. Psychological symptom scores as measured using the GAD-7.

    Time frame: 7 days

  8. Quality of life scores as measured using SF-36.

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Grünenthal GmbH

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2016
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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