NCT02659982已完成不适用
Study Protocol for Evaluation of EarlySense Home Care Tele-monitoring Device - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion For Early Detection of Deterioration For Cardiac Patients at Home
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients
研究概览
简要总结
The aim of this study is to evaluate the relevance of the information as provided by the EarlySense Home care Tele-monitoring system can provide relevant flagging information for clinicians to identify the patients at higher risk to proactively assess patients' condition
详细描述
Study objectives include:
- Assess if and to what extent the flags provided by EarlySense Home care tele-monitoring provides relevant clinical information that can help case managers / nurses of home care agency to detect patients who need further assessment and perhaps early intervention to minimize hospitalization (re-admission to hospital).
- Use data to further optimize a decision algorithm utilizing changes in physiological data over time (i.e., hours to days) which may identify patients at higher risk for poor outcomes (flagging algorithm).
- Assess the acceptability of the EarlySense Home care device by clinicians
- Assess the acceptability of the EarlySense Home care device by patients at home and their families, in their own home as determined by a provided questioner
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 and up
- •Any patient hosted in Shelev with geographically resident over 50 km from Sheba Medical Center/ Shelev
- •Patients agrees to sign the consent form and comply with study protocol.
排除标准
- •Patients do not agree to sign the consent form
- •Planned readmission within 30 days of discharge from hospital
- •Going home to hospice care.
- •Patients with cognitive constraints or disabilities
结局指标
主要结局
To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients
时间窗: 30 days
Evaluate the usability of Home Monitoring System activity indication such as number of hours spent in bed during the day in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home
次要结局
未报告次要终点
研究者
研究点 (1)
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