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

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730933
• Other study ID #: NL82384.018.22
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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