Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- adherence and utilization of end-to-end system in 30 subjects with stable New York Heart Association class I-III Heart Failure for 2 weeks
研究概览
简要总结
We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system
详细描述
The overall objective of our research is to test, adapt, refine and validate the BodyGuardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. An important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Stable New York Heart Association Class I-III HF (defined as no admissions for > 1 year)
- •Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women
- •Age > 50 years
- •Reside in Olmsted County
排除标准
- •Hospital admission for HF within past year
- •Overall life expectancy < 2 months
- •Blindness
- •Pregnancy or women able to become pregnant
- •Skin allergy to adhesives
- •Inadequate cell phone coverage (international patients or international travel during study period)
- •Documented Ejection Fraction of >40%
结局指标
主要结局
adherence and utilization of end-to-end system in 30 subjects with stable New York Heart Association class I-III Heart Failure for 2 weeks
时间窗: 12 months
To evaluate subject adherence, data transfer, clinical utilization and work-flow as well as perceptions and experiences of HF outpatients (n=30) and providers of the end-to-end remote monitoring system.
次要结局
- effect of end-to-end system on life quality(12 months)