An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Intervention
Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders
Primary outcome measures
- Treatment adherence at 12 weeks [Time frame: 12 weeks]
Secondary outcome measures (8)
- Treatment adherence at 6 months [Time frame: 6 months]
- Treatment adherence at 12 months [Time frame: 12 months]
- Differences in self-reported treatment adherence measured by brief-IPQ [Time frame: 12 weeks, 6 months and 12 months.]
- Differences in self-reported treatment adherence measured by BMQ [Time frame: 12 weeks, 6 months and 12 months.]
- Differences in self-reported treatment adherence measured by 8-point MMAS [Time frame: 12 weeks, 6 months and 12 months.]
- Differences in self-reported treatment adherence measured by MARS questionnaire [Time frame: 12 weeks, 6 months and 12 months.]
- Change in clinical symptoms measured by DSQ questionnaire [Time frame: 12 weeks, 6 months and 12 months]
- Change in clinical symptoms measured by SDI questionnaire [Time frame: 12 weeks, 6 months and 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Amsterdam UMC, location AMC — Amsterdam
Identifiers
NCT: NCT05730933 · NL82384.018.22