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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT05730933

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis	Behavioral: Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Behavioral: Intervention Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Intervention

Behavioral: Intervention

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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