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NCT Number: NCT05730933

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

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.

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Key information

Conditions

Eosinophilic Esophagitis Behavior Digestive System Diseases Eosinophilia Esophageal Diseases Esophagitis Gastroenteritis Gastrointestinal Diseases Health Behavior Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Leukocyte Disorders Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location AMC

Amsterdam, Netherlands

Location status: Recruiting

Location contact

Arjan Bredenoord, MD, PhD

CONTACT

[email protected]

+31207328382

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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

Primary outcomes

  1. Treatment adherence at 12 weeks

    Time frame: 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

  1. Treatment adherence at 6 months

    Time frame: 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

  2. Treatment adherence at 12 months

    Time frame: 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

  3. 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 brief-IPQ, a 9 item questionnaire where every item is assessed individually (0 to 10 response scale) except for 1 open-ended response item

  4. 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 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.

  5. 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 8-point MMAS. Total scores range between 0 to 8, where a higher score indicates higher treatment adherence

  6. Differences in self-reported treatment adherence measured by MARS questionnaire

    Time frame: 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

  7. Change in clinical symptoms measured by DSQ questionnaire

    Time frame: 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

  8. Change in clinical symptoms measured by SDI questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 16, 2023
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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