Temperature Telemonitoring for Hospital at Home (HaH) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Verify that, under normal conditions of use, the performance of Viture for body temperature measurement is equivalent to the devices used in the standard practice.
研究概览
简要总结
The aim of this cohort study is to validate Viture®, a continuous temperature telemonitoring system, evaluating the level of agreement with a standard commercially available digital axillary thermometer. The study also aims to evaluate the safety and comfort of the system and to evaluate the impact that the introduction of Viture has on the health care practice of a HaH unit. Furthermore, the advantages of Viture compared to the standard method will be evaluated.
详细描述
Body temperature is a key vital sign in the follow-up of patients admitted to Hospital at Home (HaH) units with COVID-19 and other infectious diseases. Continuous telemonitoring of temperature can lead to earlier detection of fever and patient deterioration that facilitates early decision making.
In the first day of the study, the patients will be given a study kit of Viture System with the following content:
- Viture Device.
- Digital reference thermometer for control Spot Temperature Measurements (STMs)
- Smartphone with Viture Mobile App installed.
- Device user manual in quick guide format.
- Home data collection notebook (HDCN)
The HaH team will place Viture Device on the patient and train the patient and/or caregiver. They will ask patients to complete control STMs between 3 and 6 times a day on the same arm where the Viture Device is placed and record the measuring data in the HDCN.
In the case that the bracelet is removed, or the patient experience discomfort, they will be asked to fill in the incident in the HDCN. Mild incidents are considered skin alterations such as redness and chafing and severe incidents are considered hematomas and ulcers.
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
- •be more than 18 years old.
- •to be able to legally give informed consent.
- •not to have limitations to the use of the Viture Device due to their physical conditions or interference with other devices.
排除标准
- •To be monitored for less than 2 days.
- •To have less than 4 valid control Spot Temperature Measurements (STM). A valid control STM is considered a temperature measured with the reference thermometer that has a simultaneous (within 1 minute) Viture Temperature Measurement (VTM)
结局指标
主要结局
Verify that, under normal conditions of use, the performance of Viture for body temperature measurement is equivalent to the devices used in the standard practice.
时间窗: 3 measurements per day
Comparison between the temperatures recorded remotely by Viture and a control digital thermometer used in the follow-up of patients in Hospital at Home, both COVID-19 patients and patients with other diseases who benefit from body temperature monitoring.
次要结局
- Evaluate the safety, usability and comfort of Viture Device(Through study completion, an average of 5 days)