To assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult EoE patients.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in treatment adherence between both groups after 12 weeks, 6 months
and 12 months.
Secondary outcome
- Differences in self-reported treatment adherence (measured by MARS
questionnaire, 8-point MMAS, BMQ, IPQ) after 12 weeks, 6 months and 12 months.
- Change in clinical symptoms (measured by SDI, DSQ) after 12 weeks, 6 months
and 12 months.
Background 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.
Study objective
To assess the effects of additional education in combination with more frequent
follow up and patient reminders on adherence to treatment in adult EoE
patients.
Study design
A single center, prospective, randomized, two-armed, blinded controlled trial.
Intervention
Subjects will be randomized into either the intervention group, in which
subjects will receive additional education in combination with more frequent
follow up and patient reminders, or the control group.
Study burden and risks
The burden of participation will be two additional hospital visits, filling out
questionnaires (not psychologically stressful) and 5 follow-up calls. There are
no risks involved in this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82384.018.22 |