Heart@Home: Advancing the Science of Pediatric Interstage Home Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Physiologic measurements
研究概览
简要总结
The overall goal of this study is to understand the feasibility of using a wireless sensor device (instead of a wired device) to collect information used to monitor children with heart conditions at home.
详细描述
The goal of this study is to examine how well continuous sensor-based monitoring performs at detecting physiologic data in infants with single ventricle physiology at home compared to existing approaches, in manner that is feasible and acceptable to patients' families. Performance features of interest include how the data compares to family measurements, whether it correlates with parents' observable symptoms, and how this approach may be integrated into home life and health system workflows. The investigators will also explore whether the collected data can be used to develop predictive analytics for acute deterioration and/or advanced chronic cardiopulmonary management compared to what is currently being done in remote patient monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving active remote patient monitoring (RPM) in Lurie's Tele-Interstage Home Monitoring Program.
- •Age 0-2 years of age at enrollment.
- •In the opinion of the investigator, parent or legally authorized guardian, and participant, the participant and (when relevant) family can follow study procedures.
排除标准
- •Is going to discontinue RPM before their enrollment would end (i.e., within 14 days).
- •Skin breakdown or severe rash at the site of sensor placement.
- •Patient without a parental guardian to consent.
- •The patient is in active hospice or similar end-of-life care.
- •The patient will be living in a long-term institution or transitional facility.
结局指标
主要结局
Physiologic measurements
时间窗: up to 14 days per patient of data collection
Physiologic data waveform morphology
次要结局
- Systems Usability Score(up to 14 days per patient of data collection)
- Utilization(up to 14 days per patient of data collection)
研究者
Carolyn Foster
Assistant Professor of Pediatrics
Northwestern University