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

NCT05730933 | Recruiting

• 1 other identifier: NL82384.018.22
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

eosinophilic esophagitis; maintenance treatment; compliance; intervention

Outcome Measures

Primary Outcomes (1)

• Treatment adherence at 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

  12 weeks

Secondary Outcomes (8)

• Treatment adherence at 6 months

  6 months

• Treatment adherence at 12 months

  12 months

• 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 BMQ

  12 weeks, 6 months and 12 months.

• Differences in self-reported treatment adherence measured by 8-point MMAS

  12 weeks, 6 months and 12 months.

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Intervention

Control

NO INTERVENTION

Interventions

Intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis; Patient Compliance

Interventions

Methods

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: April 12, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)