跳至主要内容
临床试验/NCT04550052
NCT04550052终止不适用

A-SPIRE Heart Failure: Utilizing Physiologic Information From Spire Health Tags to Identify Heart Failure Patients At-Risk for Hospital Readmission: A Pilot Feasibility Study

University of Rochester1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
36
试验地点
1
主要终点
To ascertain the feasibility of capturing appropriate signals of sleep patterns for > 80% of the time in patients following HF hospitalization for a 30-day period.

研究概览

简要总结

To evaluate the use of the Spire Health Tags in heart failure patients to determine the feasibility of capturing signals of respiration, pulse rate, activity, sleep patterns, and stress levels following HF hospitalization.

详细描述

Over 5 million Americans suffer from heart failure (HF), and treating HF as a chronic condition is associated with significant costs. In addition, about 24% of the patients discharged with a primary diagnosis of HF are readmitted to the hospital within 30 days, representing a significant public health burden. While there have been efforts to predict and reduce 30-day hospital readmission initiated by the Centers for Medicare and Medicaid Services (CMS), no studies utilized daily physiologic data from wearables to identify at-risk patients.

The overall goal of this proposed pilot feasibility study is to utilize the Spire Health Tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration, pulse rate, activity, sleep patterns, and stress levels (calm/focused/tense during the day) for > 80% of the time in patients following HF hospitalization for a 30-day period. The investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following HF hospitalization to identify risk markers that could predict 30-day readmission.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •Men and women 18 years of age or older;
  • •Admitted for acute heart failure;
  • •Expected to be discharged from hospitalization;
  • •Able to give consent;
  • •Willing to use the Spire Health Tags for 30 days continuously.

排除标准

  • •Unable or unwilling to participate in the study.

结局指标

主要结局

To ascertain the feasibility of capturing appropriate signals of sleep patterns for > 80% of the time in patients following HF hospitalization for a 30-day period.

时间窗: 30 Days

We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

To ascertain the feasibility of capturing appropriate signals of pulse rate for > 80% of the time in patients following HF hospitalization for a 30-day period.

时间窗: 30 Days

We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

To ascertain the feasibility of capturing appropriate signals of activity for > 80% of the time in patients following HF hospitalization for a 30-day period.

时间窗: 30 Days

We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

To ascertain the feasibility of capturing appropriate signals of stress levels (calm/focused/tense during the day) for > 80% of the time in patients following HF hospitalization for a 30-day period.

时间窗: 30 Days

We will evaluate capturing data in at least 80% of the time (24 days of the 30 days) using the Spire Health Tags during a 30 day period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Kutyifa

Associate Professor of Medicine (Cardiology)

University of Rochester

研究点 (1)

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