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

Not Applicable

Recruiting

• Conditions: Eosinophilic Esophagitis

• Registration Number: NCT05730933
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-16
• Study Start: 2023-04-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment adherence at 12 weeks	12 weeks	Treatment adherence, defined as the proportion of subjects in both groups that meet a desired adherence rate of \> 80%, calculated by pill count adherence rate

Secondary Outcome Measures

Name	Time	Method
Differences in self-reported treatment adherence measured by brief-IPQ	12 weeks, 6 months and 12 months.	Differences in self-reported treatment adherence measured by brief-IPQ, a 9 item questionnaire where every item is assessed individually (0 to 10 response scale) except for 1 open-ended response item
Treatment adherence at 6 months	6 months	Treatment adherence, defined as the proportion of subjects in both groups that meet a desired adherence rate of \> 80%, calculated by pill count adherence rate
Treatment adherence at 12 months	12 months	Treatment adherence, defined as the proportion of subjects in both groups that meet a desired adherence rate of \> 80%, calculated by pill count adherence rate
Differences in self-reported treatment adherence measured by BMQ	12 weeks, 6 months and 12 months.	Differences in self-reported treatment adherence measured by BMQ, questionnaire with 2 subscales. Necessity subscale ranges from 5-20, where lower scores indicate low necessity beliefs. Concern scale ranges from 5-20 where lower scores indicate higher confidence in positive effects of medication.
Differences in self-reported treatment adherence measured by 8-point MMAS	12 weeks, 6 months and 12 months.	Differences in self-reported treatment adherence measured by 8-point MMAS. Total scores range between 0 to 8, where a higher score indicates higher treatment adherence
Differences in self-reported treatment adherence measured by MARS questionnaire	12 weeks, 6 months and 12 months.	Differences in self-reported treatment adherence measured by MARS questionnaire 5. Scores range between 1-25, where a higher score indicates higher reported treatment adherence
Change in clinical symptoms measured by DSQ questionnaire	12 weeks, 6 months and 12 months	Change in clinical symptoms measured by DSQ questionnaire. Total score range from 0 to 84, where higher scores indicate more symptoms
Change in clinical symptoms measured by SDI questionnaire	12 weeks, 6 months and 12 months	Change in clinical symptoms measured by SDI questionnaire. Total scores of the SDI ranges between 0 to 9, where higher scores indicate more symptoms.

Trial Locations

Locations (1)

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands