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

NCT ID: NCT05653609

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2022-12-16

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.

Conditions

Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Telemonitoring

Patients monitored by the Cureety digital platform

Cureety TechCare

Intervention Type: DEVICE

Weekly adverse event questionnaires completed by the patients using a digital tool called Cureety

Interventions

Cureety TechCare

Weekly adverse event questionnaires completed by the patients using a digital tool called Cureety

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cureety

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cureety

Dinan, Brittany Region, France

Countries

France

Other Identifiers

CTC-2022-11-A

Identifier Type: -

Identifier Source: org_study_id