JMIR Publications

ABSTRACT

Background:

Telemedicine is currently being adopted for the management of patients in routine care. However, its use remains limited in the context of clinical trials.

Objective:

The Connectpatienttodoctor study aims to evaluate a connected telemonitoring platform, Haya by Cureety, in cancer patients included in clinical trials.

Methods:

Patients included in an interventional oncology clinical trial were eligible. Patients were registered with a digital tool to respond to a patient reported outcomes (ePRO) questionnaire based on CTCAE v.5.0, personalized to their pathology and treatment. An algorithm evaluates the health status of the patient based on the reported adverse events (AEs), with a classification in four different states (Correct, Compromise, State to be monitored or Critical State). The main objective was to evaluate the feasibility of remote monitoring via a connected platform of patients included in a clinical trial.

Results:

From July 1, 2020, to March 31, 2021, 39 patients were included. The median age was 71 years (range, 41-94), 74% were male, and 59% had metastatic disease. Out of 969 ePRO questionnaires completed over the course of the study, 77% were classified as "correct", 11% as "compromised" and 12% as "to be monitored" or “critical”. The median response time was 7 days (IQR 7-15.5) and 76% of patients (n=25/33) were compliant. Out of the 35 patients who answered a satisfaction questionnaire, 95% (n=33) were satisfied or very satisfied with the tool, 85% (n=30) were satisfied with their relationship with the health care team. There were 5 unscheduled hospitalizations during the study period.

Conclusions:

Remote monitoring in clinical trials is feasible, with a high level of patient participation and satisfaction. It benefits them but also ensures the quality of the trial, through early management of AEs and better knowledge of the tolerance profile of experimental treatments. This e-technology will likely be deployed more widely in our clinical trials.