Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation: A Potential Role for Ambient Sensor Systems in the Patients Home
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Sensitivity and specificity of ambient sensor derived digital biomarkers
研究概览
简要总结
Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.
Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admitted to hospital for worsening HF
- •age ≥ 70 years
- •LVEF < 50% and need of diuretics
- •NYHA II or III
- •living alone
- •willing to participate with informed consent.
排除标准
- •Major depression (PHQ 9-score >9)
- •being on hemodialysis
- •had been admitted to hospital for any reason within 7 days before HF decompensation.
- •patients with a left ventricular assist device
- •coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.
结局指标
主要结局
Sensitivity and specificity of ambient sensor derived digital biomarkers
时间窗: 6 months
Sensitivity and specificity of a combination of ambient sensor derived digital biomarker for the prediction of brain natriuretic peptide (BNP) increase of ≥ 20% compared to baseline value.
次要结局
- Outcome assessment(6 months)
- Quality of life (heart failure symptoms) - KCCQ(6 months)
- System Usability Scale (SUS)(6 months)
研究者
Nisha Arenja
Pinciple Investigator
Kantonsspital Olten