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

April 4, 2022 updated by: dr. L.J.J. (Luc) Derijks, Maxima Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: 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. The aim of this study is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623EJ
        • Not yet recruiting
        • Catharina hospital
        • Contact:
        • Contact:
          • Inge GPT Sauvé-van Gorp
        • Principal Investigator:
          • Janneke M Stapelbroek, MD, PhD
        • Sub-Investigator:
          • Inge GPT Sauvé-van Gorp
      • Heerlen, Noord-Brabant, Netherlands, 6419PC
        • Not yet recruiting
        • Zuyderland Medisch Centrum
        • Contact:
        • Principal Investigator:
          • Nanja Bevers, MD
      • Veldhoven, Noord-Brabant, Netherlands, 5500VB
        • Recruiting
        • Maxima Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luc JJ Derijks, PharmD, PhD
        • Sub-Investigator:
          • Kaylee Stabel, BSc
        • Sub-Investigator:
          • Coby Mesman, MSc
        • Sub-Investigator:
          • Imke A Bertrams-Maartens, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 12 up to and including 17 years old
  • Condition: IBD (Crohn's Disease and Ulcerative Colitis)
  • Treatment: azathioprine

Exclusion Criteria:

- Inability to use MedicijnWijs due to either low cognitive skills or the unavailability of a phone or other technical device to use the app on

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MedicijnWijs
All participants will undergo the same intervention of using MedicijnWijs, and they will serve as their own control.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in adherence to azathioprine therapy
Time Frame: 6 weeks
Measured as the change in Medication Adherence Report Scale-5 (MARS-5) score compared to baseline. The MARS-5 score at the start and end of the study can range from 5 to 25 points. The higher the score, the better the adherence to azathioprine therapy. The difference in MARS-5 score compared to baseline will be assessed.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knowledge about IBD
Time Frame: 6 weeks
Measured as the change in Inflammatory Bowel Disease-Knowledge Inventory Device 2 (IBD-KID2) score compared to baseline. The IBD-KID2 score at the start and end of the study can range from 0 to 15 points. The higher the score, the higher the knowledge about IBD. The difference in IBD-KID2 score compared to baseline will be assessed.
6 weeks
Ease of use of MedicijnWijs assessed by a questionnaire
Time Frame: At the end of 6 weeks
Assessed by separate questions
At the end of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maxima Medical Center

Investigators

  • Principal Investigator: Luc JJ Derijks, PharmD, PhD, Maxima Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Anticipated)

September 16, 2022

Study Completion (Anticipated)

September 16, 2022

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-MMC-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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