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临床试验/NCT05653609
NCT05653609已完成不适用

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

Cureety1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年11月15日最近更新:
适应症

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

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)

研究者

发起方
Cureety
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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