Back to resultsAn Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
Primary Purpose
Eosinophilic Esophagitis
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring eosinophilic esophagitis, maintenance treatment, compliance, intervention
Eligibility Criteria
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
Sites / Locations
- Amsterdam UMC, location AMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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.
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
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
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
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.
Full Information
NCT ID
NCT05730933
First Posted
February 7, 2023
Last Updated
May 1, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT05730933
Brief Title
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
Official Title
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
eosinophilic esophagitis, maintenance treatment, compliance, intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders
Primary Outcome Measure Information:
Title
Treatment adherence at 12 weeks
Description
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 Outcome Measure Information:
Title
Treatment adherence at 6 months
Description
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
Title
Treatment adherence at 12 months
Description
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
Title
Differences in self-reported treatment adherence measured by brief-IPQ
Description
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.
Title
Differences in self-reported treatment adherence measured by BMQ
Description
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.
Title
Differences in self-reported treatment adherence measured by 8-point MMAS
Description
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
Time Frame
12 weeks, 6 months and 12 months.
Title
Differences in self-reported treatment adherence measured by MARS questionnaire
Description
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
Time Frame
12 weeks, 6 months and 12 months.
Title
Change in clinical symptoms measured by DSQ questionnaire
Description
Change in clinical symptoms measured by DSQ questionnaire. Total score range from 0 to 84, where higher scores indicate more symptoms
Time Frame
12 weeks, 6 months and 12 months
Title
Change in clinical symptoms measured by SDI questionnaire
Description
Change in clinical symptoms measured by SDI questionnaire. Total scores of the SDI ranges between 0 to 9, where higher scores indicate more symptoms.
Time Frame
12 weeks, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arjan Bredenoord, MD, PhD
Phone
+31207328382
Email
a.j.bredenoord@amsterdamumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
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