The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Change in adherence to azathioprine therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 12 up to and including 17 years old
- •Condition: IBD (Crohn's Disease and Ulcerative Colitis)
- •Treatment: azathioprine
排除标准
- •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
结局指标
主要结局
Change in adherence to azathioprine therapy
时间窗: 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.
次要结局
- Change in knowledge about IBD(6 weeks)
- Ease of use of MedicijnWijs assessed by a questionnaire(At the end of 6 weeks)
研究者
dr. L.J.J. (Luc) Derijks
L.J.J. (Luc) Derijks, PharmD, PhD, hospital pharmacist-clinical pharmacologist
Maxima Medical Center