Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Tool

Completed

• Conditions: Neoplasms
• Interventions: Device: Cureety TechCare

• Registration Number: NCT05653609
• Lead Sponsor: Cureety

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Status Verified: 2022-12
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-14
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Study First Posted: 2022-12-16
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Telemonitoring	Cureety TechCare	Patients monitored by the Cureety digital platform

Primary Outcome Measures

Name	Time	Method
Sensitivity	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

Secondary Outcome Measures

Name	Time	Method
Specificity	Between the 1st of October 2019 and the 30th of September 2022	Specificity of the medical device to correctly identify patients who are not flagged for medical attention.

Trial Locations

Locations (1)

Cureety; 🇫🇷 Dinan, Bretagne, France