Eosinophilic EsophagitisNCT05730933
An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
A study testing Intervention in people with Eosinophilic Esophagitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam
Arjan Bredenoord, MD, PhD, +31207328382, a.j.bredenoord@amsterdamumc.nl
About this study
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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Intervention
- Keywords
- eosinophilic esophagitis, maintenance treatment, compliance, intervention
- Medical subject headings
- Eosinophilic Esophagitis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Subjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start12 Apr 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. A.J. (Arjan) Bredenoord, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730933
- Sponsor's protocol ID
- NL82384.018.22
- Status last verified
- May 2025
- First submitted
- 7 Feb 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
- ClinicalTrials.gov ID
- NCT05730933
- Acronym / sponsor ID
- NL82384.018.22
- Conditions
- Eosinophilic Esophagitis
- Keywords
- eosinophilic esophagitis, maintenance treatment, compliance, intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionSubjects will receive a behavioral intervention with additional education in combination with more frequent follow up and patient reminders | Behavioural | Intervention |
Primary outcome
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
8 secondary outcomes
Treatment adherence at 6 months
Time frame: 6 months
Treatment adherence at 12 months
Time frame: 12 months
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 BMQ
Time frame: 12 weeks, 6 months and 12 months.
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 MARS questionnaire
Time frame: 12 weeks, 6 months and 12 months.
Change in clinical symptoms measured by DSQ questionnaire
Time frame: 12 weeks, 6 months and 12 months
Change in clinical symptoms measured by SDI questionnaire
Time frame: 12 weeks, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Eosinophilic Esophagitis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.