Actively Recruiting
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-05-31
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of additional education combined with more frequent follow-up visits and patient reminders on how well adults with eosinophilic esophagitis stick to their long-term treatment plans. This trial focuses on improving treatment adherence, which is often challenging for patients with chronic conditions, including eosinophilic esophagitis. The study is led by the Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Participants are randomly assigned to one of two groups: one group receives a behavioral intervention that includes extra education, frequent follow-ups, and reminders, while the control group receives no additional intervention. The study is single-blind and monitors treatment adherence over several time points, including 12 weeks, 6 months, and 12 months. During the study, participants will be assessed for treatment adherence using various self-report questionnaires and clinical symptom changes evaluated through specific symptom questionnaires. The primary outcome is treatment adherence at 12 weeks. Secondary outcomes include adherence and symptom changes at 6 and 12 months. Participants' involvement includes regular follow-ups and completing questionnaires to track adherence and symptoms throughout the study period, which lasts up to one year.
CONDITIONS
Brief Title
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Male or female patient
- Age >18 years
- Previous diagnosis of eosinophilic esophagitis confirmed by histopathology with >15 eosinophilic granulocytes per high power field in esophageal biopsies
- Current maintenance treatment for eosinophilic esophagitis with a PPI or swallowed topical corticosteroids or about to start these treatments as decided in regular clinical practice
You will not qualify if you...
- Severe and clinically unstable concomitant disease that may interfere with study participation
- Receiving investigational treatment during the study
- Esophagus dilation required
- Insufficient Dutch or English language skills to understand patient information leaflets
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive a behavioral intervention with additional education combined with more frequent follow-up and patient reminders to improve therapeutic compliance.
Weekly visits for up to 12 weeks
Duration - Up to 12 months
Participants are monitored for treatment adherence and clinical symptoms after the intervention period.
Visits at 6 months and 12 months
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location AMC
Amsterdam, Netherlands
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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