Randomized, Cross-over, Open, Unicentric Trial Evaluating Satisfaction With the Use of a Medical Device for the Epinephrine Auto-injector in Patients With Anaphylaxis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient satisfaction through a questionnaire in the use of the medical device
研究概览
简要总结
Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients 18 years old or above
- •Patients diagnosed with Anaphylaxis and an epinephrine auto-injector prescribed
- •Patients with a smartphone
- •Patients who signed the informed consent
排除标准
- •Patients who have not signed the informed consent
- •Patients with some limitations for understanding or following correctly the trial procedures
- •Pregnant or nursing women
研究组 & 干预措施
epinephrine auto-injector
3 months using the epinephrine auto-injector alone, and after that 3 more months using the epinephrine auto-injector + medical device
epinephrine auto-injector + medical device
Device: Anapphylaxis is a medical device with a case for an epinephrine autoinjector that connects via Bluetooth to a mobile application
3 months using the epinephrine auto-injector + medical device , and after that 3 more months using the epinephrine auto-injector alone
干预措施: Device: Anapphylaxis (Behavioral)
结局指标
主要结局
Patient satisfaction through a questionnaire in the use of the medical device
时间窗: 3 months
次要结局
- Medical device safety(3 months)
- Patient Adherence to the medical device through a questionnaire(3 months)