The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in…
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Source
Brief title
Condition
- Gastrointestinal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome comprehends the psychometric properties of the PROM for
symptom assessment in functional dyspepsia.
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
functional dyspepsia (FD) are essential in order to evaluate dyspeptic
symptoms, identify potential symptom triggers and optimize therapeutic
strategies, since biological markers are 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. The aim of this study is to assess the validity and reliability of
an FD-specific electronic patient-reported outcome measure (ePRO), based on the
Experience Sampling Method-principle, for symptom assessment and identification
of symptom triggers in patients with functional dyspepsia.
Study objective
The aim of this study is to assess the validity and reliability of an
FD-specific electronic patient-reported outcome measure (ePRO), based on the
Experience Sampling Method-principle, for symptom assessment and identification
of symptom triggers in patients with functional dyspepsia. In order to measur
this, internal consistency, test-retest reliability, concurrent validity and
the accuracy to differentiate between dyspeptic patients and healthy controls
of the developed ePRO will be assessed. In addition, to objectify specific
triggers for the onset of gastrointestinal symptoms in dyspepsia, using the
FD-specific ESM tool.
Study design
This is a single center, prospective, cross-sectional study performed in the
Maastricht University Medical Center (MUMC+).
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 several 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.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for patients with functional dyspepsia
* A diagnosis of functional dyspepsia according to Rome IV criteria (2):
- One or more of the following:
- Bothersome postprandial fullness
- Bothersome early satiation
- Bothersome epigastric pain
- Bothersome epigastric burning
AND
- No evidence of structural disease (including at upper endoscopy) that is
likely to explain the symptoms.
- Criteria fulfilled for the last 3 months with symptom onset at least 6
months before diagnosis.
* Age between 18 and 75 years;
* Ability to understand and speak the Dutch language;
* Ability to understand how to utilize the ESM tool.
Inclusion criteria for healthy volunteers
* Age between 18 and 75 years
* Ability to understand and speak the Dutch language
* Ability to understand how to utilize the ESM tool.
Exclusion criteria
Exclusion criteria for patients with functional dyspepsia
* Any organic explanation for the gastrointestinal complaints;
* Initiation of regularly used medication from one month before inclusion until
the end of study participation;
* A history of upper digestive surgery influencing end points
* A history of radiation therapy of the abdomen
* Pregnancy
Exclusion criteria for healthy volunteers
* Current diagnosis of any gastrointestinal disorder
* Current gastrointestinal symptoms suiting the ROME IV criteria for FD
* Initiation of regularly used medication from one month before inclusion until
the end of study participation
* Pregnancy
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL71810.068.19 |