Observational Study of Reducing 30-day Admissions in Post-discharge Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Percentage of Participants With Health Care Utilizations
研究概览
简要总结
The purpose of this observational study is to collect and characterize multiple physiologic data from a broad subset of subjects with acute heart failure (HF)
Changes in physiologic data are expected to correlate with 30-day readmission rates in this population
详细描述
This is a multi-center, non-randomized feasibility study aimed at obtaining data from systolic and diastolic HF subjects in the hospital, with continued monitoring using an external wearable monitor for up to 4 weeks post-hospital-discharge. Data will be collected during the hospital stay and at in office follow-up visits at 1 week and 1 month post-hospital discharge
The data will help generate hypotheses and aid in determining whether development of a detection algorithm for acute heart failure decompensation is feasible. Due to the feasibility nature of this study there is no minimum required sample size but it is anticipated that the study will enroll up to 100 subjects from seven (7) study sites in the United States and one (1) study site in Australia
The study objectives are:
- Collect and characterize physiologic data from subjects with acute decompensated heart failure.
- Characterization of data related to health care utilizations within 30-days Post-discharge
- Correlation between patch monitor collected data and inpatient clinical data
- Correlation between patch monitor data and other clinical data collected after patient discharge (30-60 days)
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
- •Subject with acute decompensated heart failure
- •Subject (or legal guardian) willing to give consent for their participation
- •Subject ≥18 years of age
排除标准
- •Subject who is expected to receive a heart transplant or a ventricular assist device within 6 months
- •Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG Lead II orientation)
- •Subject with known allergies or hypersensitivities to adhesives or hydrogels
- •Subject with implantable devices with active minute ventilation sensors.
- •Subject who will not comply to study protocol requirements. This includes completing required data collection, and attending required follow up study visits.
结局指标
主要结局
Percentage of Participants With Health Care Utilizations
时间窗: 30 days post-discharge
Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.
次要结局
- Change in Body Weight Per Unit Change in Thoracic Impedance(Discharge to 30 days post discharge)