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

Study Overview
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Brief Summary
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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.

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

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Intervention<br>* Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| 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 | 12 months | 
| 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 | 12 weeks, 6 months and 12 months. | 
| 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. | 12 weeks, 6 months and 12 months. | 
| Differences in self-reported treatment adherence measured by 8-point MMAS | 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 | 12 weeks, 6 months and 12 months. | 
| Differences in self-reported treatment adherence measured by MARS questionnaire | 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 | 12 weeks, 6 months and 12 months. | 
| Change in clinical symptoms measured by DSQ questionnaire | Change in clinical symptoms measured by DSQ questionnaire. Total score range from 0 to 84, where higher scores indicate more symptoms | 12 weeks, 6 months and 12 months | 
| Change in clinical symptoms measured by SDI questionnaire | Change in clinical symptoms measured by SDI questionnaire. Total scores of the SDI ranges between 0 to 9, where higher scores indicate more symptoms. | 12 weeks, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eosinophilic esophagitis, maintenance treatment, compliance, intervention