The Nori Health App: (Pilot) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient Activation Measure (PAM)
研究概览
简要总结
A multicenter, randomized controlled trial with an embedded pilot and qualitative component to investigate the effects of the Nori Health app.
详细描述
RATIONALE Inflammatory bowel disease (IBD) is an umbrella term used to describe diseases that involve chronic inflammation of the gastrointestinal tract. Although progress in treatment has been made over the past two decades, IBD continues to profoundly affect patients' quality of life. Since patients with IBD have to deal with their disease's complex and unpredictable nature 24 hours a day, it is important that they have access to self-management support outside the hospital. Nori Health aims to provide this support with an app that consists of an artificial intelligence-driven chatbot and 6-week education program.
OBJECTIVES
The primary objective is to investigate whether use of the Nori Health app improves the level of patient activation for self-management in patients with IBD by comparing an intervention and (waiting-list) control group at 6 weeks after randomization. Secondary objectives are:
- To investigate whether there are any differences between the intervention and control group in the level of patient activation for self-management at 12 and 20 weeks after randomization;
- To investigate whether there are any differences between the intervention and control group in the level of disease control at 6, 12 and 20 weeks after randomization;
- To investigate whether there are any differences between the intervention and control group in quality of life at 6, 12 and 20 weeks after randomization;
- To investigate whether there are any differences between the intervention and control group in healthcare utilization at 6, 12 and 20 weeks after randomization;
- To investigate intervention fidelity at 6, 12 and 20 weeks after randomization;
- To explore the experiences of patients with IBD with use of the Nori Health app and their views on its pros and cons.
STUDY DESIGN A multicenter, randomized controlled trial with an embedded pilot and qualitative component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient Activation Measure (PAM)
时间窗: 6 weeks follow-up
Measure of patient activation for self-management. Scale from 0 to 100, higher scores mean a higher level of patient activation for self-management (=better outcome).
次要结局
- Patient Activation Measure (PAM)(12 and 20 weeks follow-up)
- Healthcare utilization(6, 12 and 20 weeks follow-up)
- Inflammatory Bowel Disease (IBD)-control questionnaire(6, 12 and 20 weeks follow-up)
- EuroQol-5 dimension questionnaire (EQ-5D)(6, 12 and 20 weeks follow-up)
研究者
Elke Mathijssen
Principal investigator
UMC Utrecht