Eosinophilic Esophagitis
Conditions
Keywords
eosinophilic esophagitis, maintenance treatment, compliance, intervention
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.
Interventions
BEHAVIORALIntervention
Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment adherence at 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment adherence at 12 months | 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 | 12 weeks, 6 months and 12 months. | 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 | 12 weeks, 6 months and 12 months. | 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. |
| Treatment adherence at 6 months | 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 |
| Differences in self-reported treatment adherence measured by MARS questionnaire | 12 weeks, 6 months and 12 months. | Differences in self-reported treatment adherence measured by MARS questionnaire 5. Scores range between 1-25, where a higher score indicates higher reported treatment adherence |
| Change in clinical symptoms measured by DSQ questionnaire | 12 weeks, 6 months and 12 months | Change in clinical symptoms measured by DSQ questionnaire. Total score range from 0 to 84, where higher scores indicate more symptoms |
| Change in clinical symptoms measured by SDI questionnaire | 12 weeks, 6 months and 12 months | Change in clinical symptoms measured by SDI questionnaire. Total scores of the SDI ranges between 0 to 9, where higher scores indicate more symptoms. |
| 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 8-point MMAS. Total scores range between 0 to 8, where a higher score indicates higher treatment adherence |
Countries
Netherlands
Outcome results
None listed