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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country72 target enrollmentApril 12, 2023

ConditionsEosinophilic Esophagitis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Eosinophilic Esophagitis
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment: 72
Locations: 1
Primary Endpoint: Treatment adherence at 12 weeks
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 12, 2023

End Date

December 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Principal Investigator

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

Principal Investigator

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

Eligibility 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

•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

Outcomes

Primary Outcomes

Treatment adherence at 12 weeks

Time Frame: 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 Outcomes

Differences in self-reported treatment adherence measured by brief-IPQ(12 weeks, 6 months and 12 months.)
Treatment adherence at 6 months(6 months)
Treatment adherence at 12 months(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.)
Differences in self-reported treatment adherence measured by MARS questionnaire(12 weeks, 6 months and 12 months.)
Change in clinical symptoms measured by DSQ questionnaire(12 weeks, 6 months and 12 months)
Change in clinical symptoms measured by SDI questionnaire(12 weeks, 6 months and 12 months)