A Study Evaluating the Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Platform: a Database Study to Validate the Cureety TechCare Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cureety
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
Cureety is a digital telemonitoring platform specifically designed to monitor cancer patients through self-reporting of adverse events, accompany patients and their medical teams and complement existing healthcare practices. The platform aims to detect signs and symptoms of health deterioration and disease progression, allowing the medical team to intervene earlier than usual compared to conventional care.
The patients are asked to respond to an electronic patient-reported outcome (ePRO) questionnaire. The digital tool is configured for each patient that generates specific questions that allow grading of adverse events relevant to their specific treatment and disease profile.
At the core of the platform is the medical device "Cureety TechCare", an algorithm that outputs a "clinical classification" based on the adverse events reported by the patients. There are four levels that correspond to the patients' health states, either "critical" ("red"), "to be monitored" ("orange"), "compromised" ("yellow"), or "correct" ("green"). In the case of a red or orange classification, the patients are asked to contact their medical team. In addition, the medical team can monitor the patient classifications from a distance including receiving notifications when patients are classified red and orange.
The present study was designed to retrospectively evaluate the performance of the "Cureety TechCare" medical device in real-life using data collected in the Cureety database.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or older.
- •Patients that have completed at least one questionnaire in Cureety
- •Patients that have not exercised their right to oppose to the use of their data for clinical research.
排除标准
- 未提供
结局指标
主要结局
Sensitivity
时间窗: Between the 1st of October 2019 and the 30th of September 2022
Sensitivity of the medical device to correctly identify patients who are flagged for medical attention
次要结局
- Specificity(Between the 1st of October 2019 and the 30th of September 2022)
