NCT05730933RecruitingNot Applicable
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 enrollmentStarted: April 12, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Treatment adherence at 12 weeks
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention
Experimental
Intervention: Intervention (Behavioral)
Control
No Intervention
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)
Investigators
Prof.dr. A.J. (Arjan) Bredenoord
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sites (1)
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