The 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. The objectives, therefore, are to establish the validity and…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome comprehends the psychometric properties (i.e. content
validity, cross-cultural adaptation, concurrent validity, internal consistency
and test-retest reliability) of the PROM for symptom assessment of abdominal
pain.
Secondary outcome
Secondary outcomes are associations between the presence of psychosocial and
environmental factors (e.g. as measured by the PROM) and an increase in ESM
score for gastrointestinal symptoms from one time point (t-1) to the next (t).
Background 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 characterised by random and repeated, momentary assessments in the
subject*s current state and environment, might overcome these limitations.
Study objective
The 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. The objectives, therefore, are
to establish the validity and reliability, i.e. psychometric properties, of the
developed PROM for the assessment of abdominal pain and other gastrointestinal
symptoms, i.e. bloating, flatulence, abdominal rumbling, in IBS patients. An
additional objective is to determine specific triggers for the onset of
abdominal complaints in irritable bowel syndrome, using the IBS specific ESM
tool.
Study design
This is a multicenter, prospective, cross-sectional study, in which five
secondary and tertiary referral centers for gastrointestinal diseases are
participating.
Study burden and risks
The burden that is associated with participation in this study comprises
completing the PROM questionnaire several times a day, which interrupts daily
life due to its random character. Furthermore, the burden is limited to
completing an end-of-day symptom diary and end-of-week questionnaires. However,
participating does not bring along important risks. No direct benefits are
expected, since the study does not contain any interventions.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of IBS according to Rome IV criteria, age 18-70, ability to understand and speak the concerning language, ability to understand how to use the ESM.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnotyetassigned |
| CCMO | NL57473.068.16 |