The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD
NCT ID: NCT05321485
Last Updated: 2022-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-03-16
2022-09-16
Brief Summary
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Detailed Description
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Objective: with this study, the effect of the mobile phone app MedicijnWijs on adherence to azathioprine therapy will be assessed. In addition, the effect on knowledge about IBD and the ease of use of MedicijnWijs will be studied as well.
Study design: this study is a multicenter before-and-after study. Study population: the study population are adolescents aged 12 up to and including 17 years old. All participants are diagnosed with IBD and are treated with azathioprine. This multicenter study will be conducted in Máxima Medical Center in Veldhoven, Catharina Hospital in Eindhoven, and Zuyderland Medical Center in Sittard-Geleen/Heerlen, The Netherlands.
Intervention: the participants will use the mobile phone app MedicijnWijs for 6 weeks. In this app, information about IBD and azathioprine is provided. Participants also receive questions about their symptoms through the app. Moreover, at the beginning of the study the participants have to fill in two validated questionnaires that are translated to Dutch in the app: 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. 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.
Main study parameters/endpoints: the main endpoint is change in adherence to azathioprine therapy measured as a change in MARS-5 score. In addition, the secondary endpoint change in knowledge about IBD measured as a change in IBD-KID2 score will be studied as well. The results of the secondary endpoint ease of use of MedicijnWijs will be presented descriptively.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: there are no risks associated with participation to this study as participants only have to use a mobile phone app and fill in two short questionnaires. MedicijnWijs has to be used for 6 weeks. The time burden per day varies from 0 to 10 minutes. The IBD treatment of the participants will not change, and participants will visit their doctors as frequently as usual. Only an additional introductory talk will be necessary, which will be scheduled during a regular outpatient clinic visit. No physical examinations, blood tests, or other tests will be done during this study apart from routine care of IBD.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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MedicijnWijs
All participants will undergo the same intervention of using MedicijnWijs, and they will serve as their own control.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Condition: IBD (Crohn's Disease and Ulcerative Colitis)
* Treatment: azathioprine
Exclusion Criteria
12 Years
17 Years
ALL
No
Sponsors
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Maxima Medical Center
OTHER
Responsible Party
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dr. L.J.J. (Luc) Derijks
L.J.J. (Luc) Derijks, PharmD, PhD, hospital pharmacist-clinical pharmacologist
Principal Investigators
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Luc JJ Derijks, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maxima Medical Center
Locations
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Catharina Hospital
Eindhoven, North Brabant, Netherlands
Zuyderland Medisch Centrum
Heerlen, North Brabant, Netherlands
Maxima Medical Center
Veldhoven, North Brabant, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Inge GPT Sauvé-van Gorp
Role: backup
Other Identifiers
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2022-MMC-029
Identifier Type: -
Identifier Source: org_study_id
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