FFG PREMEDICAL (Clinical Investigation of a Medical Device According to MDR Article 82, Para.1 and Austrian Law §13 Para. 3 MPG, BGBI. I No. 122/2021 - Study Without Influence on Diagnostics/Therapy)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- XUND Symptom Checker
研究概览
简要总结
The goal of this clinical investigation is to create a new type of data basis that can be used to enrich information collected in the course of the classic patient journey, such as medical history forms and discharge letters. Therefore, it is planned to collect new, patient-related and symptom-oriented data on site and directly from patients in the emergency department (female/male; at least 18 years old).
The main question it aims to answer is:
- Can a detailed medical history with additional enriched information from XUND improve the quality of outpatient care?
Selected patients in the waiting area of the emergency department will record their symptoms on a tablet and answer the questions asked about their symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •a signed informed consent form;
- •signed consent and admission to the emergency department of the emergency medicine clinic
- •Triage category 3, 4 or 5 based on the triage procedure according to the Manchester triage system used in Austria
- •the physical and mental ability to operate the tablet and answer the questions
- •18 years of age or older;
- •knowledge of the German language.
排除标准
- •not meeting all inclusion criteria
结局指标
主要结局
XUND Symptom Checker
时间窗: through investigation completion, an average of 1 year
The fundamental element of the proposed project is the aggregation of novel, patient-related and symptom-oriented data on-site and directly from patients in the emergency department. The objective of this study is to establish a novel type of data basis, with the potential to enhance the information collected during the conventional patient journey, including medical history forms and discharge letters. XUND's Symptom Check, which has been certified as a class IIa medical device, will be used to collect the data. Selected patients in the emergency waiting area record their symptoms on a tablet and answer the questions asked. The Symptom Check is powered by an AI-driven medical knowledge base of 520+ conditions and 21,000+ symptom variants.
次要结局
未报告次要终点