Management of COPD Patients with BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations

Last updated: January 2, 2025
Sponsor: Biosency
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Boracare remote monitoring solution

Clinical Study ID

NCT06523140
2023-A02454-41
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations (experimental group) compared to conventional follow-up alone (control group) on the total number of hospital days per patient for respiratory deterioration over 12 months of follow-up.

The main question it aims to answer is: Does remote monitoring of COPD patients reduce the average annual length of hospitalization for exacerbations of COPD patients?

All participants will benefit a conventional clinical follow-up.

Participants in experimental group will also benefit from the Bora care remote monitoring system.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient over 18 years of age with COPD defined according to the recommendations ofthe SPLF, whose level of respiratory function in a stable state is known (measuredless than 12 months), recruited in pulmonology

  • Patient who has been hospitalized for COPD exacerbation in the previous 12 months

  • Informed patient who has signed consent,

  • Patient enrolled in a social security scheme (Art L1121-11 of the CSP)

Exclusion

Exclusion Criteria:

  • Presence of a comorbidity considered unstable or very severe by the investigator.

  • Patient with psychological frailties,

  • Patient already included in another interventional trial,

  • Patient who does not speak French and is unable to use the Bora Band tool andwithout access to a caregiver,

  • Patient protected under guardianship or unable to give free and informed consent.

  • Pregnant or nursing woman

Study Design

Total Participants: 360
Treatment Group(s): 1
Primary Treatment: Boracare remote monitoring solution
Phase:
Study Start date:
November 20, 2024
Estimated Completion Date:
December 31, 2027

Study Description

Control group (control): conventional follow-up For the target population (frequent exacerbating COPD patients), the usual follow-up includes two consultations with the general practitioner and one consultation with the pulmonologist per year. The inclusion and follow-up visit at 12 months by a pulmonologist are consistent with the follow-up of COPD patients in current practice and the recommendations of HAS (National Authority for Health) and SPLF (French-Language Society of Pneumology).

Experimental group (conventional monitoring + remote monitoring):

The patients will be subject to conventional clinical follow-up and at the same time benefit from the Bora care remote monitoring system. The Bora care remote monitoring system includes a BoraBand wristband measuring vital signs at home, the Bora Connect platform for caregiver visualization of data and the BVS3 score for early detection of COPD exacerbations. Patients are monitored daily remotely by Case Managers (nurses trained in Bora Care solution), who, when the BVS3 > 3 alert is triggered on Bora Connect, call the patient to inform the patient about his symptoms, then alert the pulmonologist by transmitting the information from Bora Connect and the minutes of the phone call, who, according to conventional management, decides whether or not to hospitalize the patient, or to generate an unscheduled consultation in order to prescribe drug treatment, and/or to prescribe additional examinations, and/or to adapt the patient's oxygen therapy prescription.

The Case Manager re-evaluates the situation after 48 hours and 96 hours if necessary and forwards the information to the pulmonologist. The nature of the transmission of information (telephone or email) between the Case Manager and the pulmonologist in case of an alert is defined when the patient is included by the pulmonologist. If desired, remotely monitored patients will be able to access the Bora Connect interface provided for patients (restricted viewing of data).

Connect with a study center

  • Hôpital Cochin - AP-HP

    Paris, 75014
    France

    Active - Recruiting

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