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OpenTrials
Completed

NCT Number: NCT05653609

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cureety

Dinan, Brittany Region, 22100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cureety TechCare

Device

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

Primary outcomes

  1. Sensitivity

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

    Sensitivity of the medical device to correctly identify patients who are flagged for medical attention

Secondary outcomes

  1. Specificity

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

    Specificity of the medical device to correctly identify patients who are not flagged for medical attention.

Sponsors and collaborators

Lead sponsor

Cureety

Industry

Registry information

Official study 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

Acronym: POSITEA-VA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2022
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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