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An intervention study to improve therapeutic compliance in adult patients with eosinophilic esophagitis.

An intervention study to improve therapeutic compliance in adult patients with eosinophilic esophagitis. - EoE compliance

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51510
Enrollment
72
Registered
2022-11-08
Start date
2023-04-12
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

allergic esophagitis Eosinophilic esophagitis

Interventions

Subjects will be randomized into either the intervention group, in which subjects will receive additional education in combination with more frequent follow up and patient reminders, or the control

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Differences in treatment adherence between both groups after 12 weeks, 6 months and 12 months.

Secondary

MeasureTime frame
- Differences in self-reported treatment adherence (measured by MARS questionnaire, 8-point MMAS, BMQ, IPQ) after 12 weeks, 6 months and 12 months. - Change in clinical symptoms (measured by SDI, DSQ) after 12 weeks, 6 months and 12 months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)