An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.

NCT ID: NCT05730933

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-12

Study Completion Date

2025-12-31

Brief Summary

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In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.

Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention

Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Prof.dr. A.J. (Arjan) Bredenoord

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Arjan Bredenoord, MD, PhD

Role: primary

+31207328382

Other Identifiers

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NL82384.018.22

Identifier Type: -

Identifier Source: org_study_id

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