An intervention study to improve therapeutic compliance in adult patients with eosinophilic esophagitis.
- Conditions
- allergic esophagitisEosinophilic esophagitis10017969
- Registration Number
- NL-OMON51510
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
- Written informed consent
- Male or female patient
- Age >18 years
- Previous diagnosis of EoE, confirmed by histopathology, with the presence of
>15 eosinophilic granulocytes per high power field (hpf) in esophageal biopsies
- Current maintenance treatment for EoE with a PPI or swallowed topical
corticosteroids or about to start with these maintenance medications as decided
during regular clinical practice
- Severe and clinically unstable concomitant disease that may interfere with
the subject*s ability to participate in the study
- Receive investigational treatment during the study
- Dilation of esophagus required
- Insufficient Dutch or English language skills to understand patient
information leaflets
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Differences in treatment adherence between both groups after 12 weeks, 6 months<br /><br>and 12 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Differences in self-reported treatment adherence (measured by MARS<br /><br>questionnaire, 8-point MMAS, BMQ, IPQ) after 12 weeks, 6 months and 12 months.<br /><br>- Change in clinical symptoms (measured by SDI, DSQ) after 12 weeks, 6 months<br /><br>and 12 months.</p><br>