AeviceMD for Pediatric Asthma Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the effectiveness of implementing home monitoring technology for asthma patients in delivering care to patients and in extension determine, if Aevice Medical Device can improve home management of Asthma for pediatrics patients.
研究概览
简要总结
A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study. Patients prescribed with AeviceMD should be able to gain better control over their disease during home management. Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic. The AeviceMD should also be used as a remote auscultation device for teleconsultations.
详细描述
Participants are asked to take part in this research study because they have been diagnosed with poorly controlled asthma. As a chronic respiratory disease, management of the disease relies not only on healthcare professionals delivering care at various clinical touch points, but also depends heavily on a participant's own ability to understand, monitor, and manage their conditions when at home. The investigators know that for pediatric patients, like for many other children, self-monitoring is often difficult. This clinical pilot investigates the use of a wearable medical device that can conduct continuous monitoring of vital signs and detect wheezing when worn at home. The continued use of this device (especially during night sleep) gives insight to the course of symptoms, while also providing early warning should a participant's condition worsen. The device can also be used as a digital stethoscope, meaning physicians can examine participants via teleconference and obtain useful data for clinical decision making.
Study participants include: 20 pediatric patients (between 3 to 18 years of age) who have been diagnosed with poorly controlled asthma while presenting at Cedars-Sinai Medical Center Guerin Children's. Participants will be enrolled to use the AeviceMD device during night sleeps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Aged 3 to 18 as of first recruitment
- •Diagnosed with poorly controlled asthma
- •Asthma control test score below
- •Caregiver able operate a mobile application
- •Has access high-speed wireless internet (WiFi) at home
- •Able to read English
- •Agreement to adhere to medical device use regimen throughout the study duration
排除标准
- •Known allergy to silicone, gold, or zinc
- •Abnormal skin conditions on chest
- •Sleep apnea diagnosis
研究组 & 干预措施
AeviceMD
This is a single site, single arm, open label medical device (AeviceMD) pilot where only intervention groups will be recruited.
干预措施: AeviceMD (Device)
结局指标
主要结局
To evaluate the effectiveness of implementing home monitoring technology for asthma patients in delivering care to patients and in extension determine, if Aevice Medical Device can improve home management of Asthma for pediatrics patients.
时间窗: 3 Months
The study primary objectives are met if enrolled patients achieve better manage of their asthma shown by a reduction in admission rate, improvement in patient satisfaction, and quality of life. For this purpose, the Pediatric Asthma Control and Communication Instrument (PACCI) system will be utilized. This is a 12-item questionnaire resulting in a sum score ranging from 0 (best asthma control) to 19 (worst asthma control). A decrease in the sum score indicates an improvement in asthma control.
次要结局
- To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations.(3 Months)
研究者
Irina Dralyuk
Principal Investigator
Cedars-Sinai Medical Center