About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Intervention
BehavioralSubjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Treatment adherence at 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
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 brief-IPQ
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
Differences in self-reported treatment adherence measured by BMQ
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.
Sponsors and contacts
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