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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention

    Behavioral

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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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

Time frame
12 weeks

Secondary outcomes

1

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

Time frame
6 months
2

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

Time frame
12 months
3

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

Time frame
12 weeks, 6 months and 12 months.
4

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.

Time frame
12 weeks, 6 months and 12 months.

Other outcomes

Sponsors and contacts

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