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Clinical Trials/NCT05653609
NCT05653609
Completed
Not Applicable

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

Cureety1 site in 1 country400 target enrollmentNovember 15, 2022
ConditionsNeoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoplasms
Sponsor
Cureety
Enrollment
400
Locations
1
Primary Endpoint
Sensitivity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
December 16, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Cureety
Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

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

  • Specificity(Between the 1st of October 2019 and the 30th of September 2022)

Study Sites (1)

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