Observational Pilot Study on the Use of the HERO Health Monitoring System for the Detection of Vital Signs, Emotional States, and Body Postures
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Level of agreement between heart rate (measured as beats per minute) collected via HHM (Home Health Monitoring) system and those obtained from standard telemetry monitoring, measured using Intraclass Correlation Coefficient
研究概览
简要总结
New technologies offer significant opportunities to enhance the quality and intensity of care services, amplifying the ability to respond to patient needs through contactless solutions that also contribute to the humanization of care. Their application in patient monitoring can enable continuous observation, even in the absence of physically present staff, for a larger number of non-critical patients (thus reducing the risk of adverse events), and facilitate timely interventions when needed-aligned with the logic of Anglo-Saxon models based on Early Warning Systems.
The general objective of this study is to conduct a pilot clinical trial of a specific solution based on Artificial Intelligence and Computer Vision, the HERO Health Monitoring (HHM) system, capable of detecting vital signs (heart rate, respiratory rate, blood oxygen saturation, and blood pressure), body posture, movements, and patients' emotional states-such as expressions of pain-using simple video devices.
The study aims, in particular, to measure the concordance of the system's vital sign measurements with standard (telemetric) systems, and to assess the added value of combining these measurements with the additional information provided by HHM regarding posture, movement, and emotional state analysis-once their agreement has been verified against patient-reported outcomes collected via self-assessment questionnaires.
This is an observational study involving the HERO Health Monitoring medical device, for which the certification process is expected to be completed through the present study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
Level of agreement between heart rate (measured as beats per minute) collected via HHM (Home Health Monitoring) system and those obtained from standard telemetry monitoring, measured using Intraclass Correlation Coefficient
时间窗: 6 months
This measure evaluates the level of concordance between heart rate (measured as beats per minute) collected by the HHM (Home Health Monitoring) system and those obtained from standard clinical telemetric monitoring systems. The agreement will be assessed using statistical methods such as Bland-Altman analysis, Intraclass Correlation Coefficient (ICC), and/or paired t-tests depending on the distribution and type of data. Measurements will be reported as mean values with standard deviations, and limits of agreement where appropriate.
次要结局
未报告次要终点
研究者
TINELLI GIOVANNI
Head Endovascular Unit at Fondazione Policlinico Gemelli IRCCS in Rome; Associate Professor of Vascular Surgery at Università Cattolica del Sacro Cuore in Rome, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
