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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Device: Cureety TechCare


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telemonitoring<br>Patients monitored by the Cureety digital platform | Device: Cureety TechCare<br>* Weekly adverse event questionnaires completed by the patients using a digital tool called Cureety<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity of the medical device to correctly identify patients who are flagged for medical attention | Between the 1st of October 2019 and the 30th of September 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | Specificity of the medical device to correctly identify patients who are not flagged for medical attention. | Between the 1st of October 2019 and the 30th of September 2022 |