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

NCT05653609 | Completed

• 1 other identifier: CTC-2022-11-A
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Specificity

  Between the 1st of October 2019 and the 30th of September 2022

Study Arms (1)

Telemonitoring

Patients monitored by the Cureety digital platform

Device: Cureety TechCare

Interventions

Cureety TechCare DEVICE

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

Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be randomly selected from all 1530 patients that used the Cureety telemonitoring platform between the 1st of October 2019 and the 30th of September 2022.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Cureety: lead

Study Sites (1)

Cureety

Dinan, Brittany Region, 22100, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 16, 2022
• Study Start: November 15, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: February 9, 2023

Record last verified: 2022-12

Locations

FR (1)