NCT06752512招募中不适用
Remote Temperature Monitoring of Patients At Risk for Developing Fever
AION Biosystems2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年8月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mean number of inpatient days
研究概览
简要总结
The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are:
- does remote temperature monitoring reduce the number of days spent inpatient
- what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring
- the number of billable CPT codes that will be generated by providing remote temperature monitoring
Researchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient.
Patients will
- wear the thermometer for the duration of their participation in the study
- have their temperature monitored continuously
- receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician
- respond to texts or calls from remote monitors when an alert is triggered
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subject is at risk of a fever post discharge.
- •Subject is ≥ 18 years or older.
- •Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.
- •Subject is willing to install the TempShield app on his/her phone.
- •Subject is willing to allow AION to send text reminders to take temperature or complete surveys.
- •Subject is willing to take an oral temperature as directed by their care plan.
- •Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.
- •Subject or subject caretaker is able and willing to complete subject surveys.
- •Subject is willing and able to provide written informed consent in English.
- •Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires.
- •English speakers
排除标准
- •Unable to provide informed consent
- •Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)
- •Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)
- •Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.
- •Subjects receiving prophylactics that could induce fever.
- •Subjects with a silicon allergy
- •Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device.
- •Subjects who are not willing to take an oral temperature per their care plan.
结局指标
主要结局
Mean number of inpatient days
时间窗: Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment
The number of days the participant was admitted to a hospital while receiving remote patient monitoring
次要结局
- Mean out-of-pocket cost(Day of enrollment)
- Number of CPT codes generated(Day of enrollment to the end of participation in the study, a maximum of 180 days after enrollment)
研究者
研究点 (2)
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