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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05653609
Acronym
POSITEA-VA
Enrollment
400
Registered
2022-12-16
Start date
2022-11-15
Completion date
2022-12-16
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

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.

Interventions

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

Sponsors

Cureety
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SensitivityBetween the 1st of October 2019 and the 30th of September 2022Sensitivity of the medical device to correctly identify patients who are flagged for medical attention

Secondary

MeasureTime frameDescription
SpecificityBetween the 1st of October 2019 and the 30th of September 2022Specificity of the medical device to correctly identify patients who are not flagged for medical attention.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026