MedTrace Logo

The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD

NCT05321485 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-11

No results posted yet for this study

Summary

Medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Previous research has shown education can increase medication adherence. MedicijnWijs is a mobile phone app containing a module concerning a 6-weeks guidance with azathioprine therapy. It provides information about IBD and azathioprine. In this multicenter before-and-after study, the aim is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. This is done using two validated questionnaires that are translated to Dutch: the Medication Adherence Report Scale-5 (MARS-5), which tests the participants' adherence to azathioprine therapy, and the Inflammatory Bowel Disease Knowledge Inventory Device 2 (IBD-KID2), which tests the participants' knowledge about IBD. These questionnaires are filled in at the beginning of the study period and after 6 weeks of using MedicijnWijs. This way a change in both scores can be assessed. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.

Conditions

Interventions

OTHER

MedicijnWijs

The mobile phone app MedicijnWijs will guide the participants with their azathioprine therapy during 6 weeks. Information about azathioprine is given as well as general information about IBD, specified to disease modality (Crohn's Disease and Ulcerative Colitis). Contact details of the patient's pharmacy are listed, questions about the patient's symptoms are asked, and push notifications are added to remind the patients to take their medication. At the beginning of the 6-weeks guidance, two validated questionnaires that are translated and validated in Dutch will have to be filled in: the MARS-5 and the IBD-KID2. After 6 weeks, the participants have to fill out the same questionnaires again to assess potential changes in the scores compared to baseline. Also, a number of questions will be asked to assess the ease of use of MedicijnWijs.

Sponsors & Collaborators

  • Maxima Medical Center

    lead OTHER

Principal Investigators

  • Luc JJ Derijks, PharmD, PhD · Maxima Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2022-09-16
Completion
2022-09-16

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321485 on ClinicalTrials.gov