Validation of the Withings Heart Function Risk Notification (HFRN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Withings
- 入组人数
- 9,000
- 试验地点
- 1
- 主要终点
- Sensitivity (Se) of the HFRN algorithm
研究概览
简要总结
This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)
详细描述
This is a fully decentralized retrospective study.
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
- 45 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Users of commercially purchased, consumer-grade Withings smart scales
- •A source of step counts synced into the Withings ecosystem (a Withings activity tracker, a smartphone, or a third-party activity tracker)
- •Claims linkage available, enabling heart-failure ground-truth ascertainment
- •Age >= 45 years
- •At least one 13-week quarter in which at least one of the three quarterly features (mean BMI, standard deviation of body-water percent, 90th-percentile daily steps) can be computed
排除标准
- •Users for whom heart-failure status cannot be determined from claims (unknown label; e.g. controls with < 2 years of continuous enrollment)
- •Users with no usable measurement after per-reading plausibility screening
- •Users without an individual Withings account (shared accounts excluded to prevent data contamination)
研究组 & 干预措施
HF Cases
Withings smart-scale users
干预措施: Claims-based heart-failure adjudication (reference standard) (Other)
HF Cases
Withings smart-scale users
干预措施: Withings Heart Function Risk Notification (HFRN) (Device)
Control
Withings smart-scale users, control set
干预措施: Withings Heart Function Risk Notification (HFRN) (Device)
Control
Withings smart-scale users, control set
干预措施: Claims-based heart-failure adjudication (reference standard) (Other)
结局指标
主要结局
Sensitivity (Se) of the HFRN algorithm
时间窗: 13 weeks
Specificity (Sp) of the HFRN algorithm
时间窗: 13 weeks
次要结局
未报告次要终点