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临床试验/NCT04254614
NCT04254614已完成不适用

A Mobile Application Guiding Patients With Inflammatory Bowel Disease During Biologic Treatment

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Adherence

研究概览

简要总结

Monitoring of biologic treatment in patients with inflammatory bowel disease (IBD) is important given the increased risk of infections. In this study we aim to evaluate the use of a mobile application to guide IBD patients and facilitate the monitoring of biologic treatment.

详细描述

Biologic treatment can induce and maintain remission in patients with inflammatory bowel disease (IBD). However, biologics are associated with increased risk of infections. Therefore, it is important to regularly monitor patients during the course of therapy. This process can be time consuming for patients as well as clinicians. Mobile applications, have the potential to guide patients and facilitate monitoring of biologic treatment. In this study we aim to evaluate the use of a mobile application to guide IBD patients during biologic treatment. Adult patients with diagnosis of IBD treated with biologics will be included. The mobile application with personalised content will give patients information about their treatment, reminders for example when blood tests and questionnaires to check for adverse events.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of inflammatory bowel disease
  • Treatment with infliximab or vedolizumab
  • Ability to read and understand Dutch language

排除标准

  • Patients recently started with biologic treatment

结局指标

主要结局

Adherence

时间窗: 6 months

The adherence of patients to reminders will be evaluated by checking time of blood tests as recorded in the electronic medical record and log data from administered questionnaires.

Patient satisfaction

时间窗: 6 months

All patients will be asked to complete questions about satisfaction with the mobile application, the information in the app and the user-friendliness of the app. This will be measured with a 7-point likert scale after using the application for ± 6 months. We will also ask patients about their overall satisfaction of care before and after implementation of the application using a visual analogue scale (VAS) scale 0 - 10.

Actual use - frequency

时间窗: 6 months

Use will be monitored with log data of the application. We will look at frequency of use of the application.

次要结局

  • Satisfaction of care providers(6 months)
  • Overall satisfaction of care providers(6 months)
  • Number of telephone contacts(6 months)
  • Number of outpatient visits(6 months)
  • Disease and treatment knowledge(6 months)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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