Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Tool (POSITEA-VA)

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Device: Cureety TechCare

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Dinan, Bretagne, France, 22100
      • Cureety

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Telemonitoring; Patients monitored by the Cureety digital platform	Device: Cureety TechCare; Weekly adverse event questionnaires completed by the patients using a digital tool called Cureety

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

Collaborators and Investigators

• Sponsor: Cureety

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2022
• Primary Completion (ACTUAL): December 16, 2022
• Study Completion (ACTUAL): December 16, 2022

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (ACTUAL): December 16, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: CTC-2022-11-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No