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

Neoplasms Clinical Trial

— POSITEA-VA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05653609
• Other study ID #: CTC-2022-11-A
• Status: Completed
• Start date: November 15, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: December 2022
• Source: Cureety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Neoplasms

Intervention

Device:
• Cureety TechCare
Weekly adverse event questionnaires completed by the patients using a digital tool called Cureety

Locations

Country	Name	City	State
France	Cureety	Dinan	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Cureety

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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