Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient over 18 years of age with COPD defined according to the recommendations of the SPLF, whose level of respiratory function in a stable state is known (measured less 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)

Locations
Other Locations
France
CHU de Brest
RECRUITING
Brest
Centre Hospitalier de Chartres
NOT_YET_RECRUITING
Le Coudray
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
NOT_YET_RECRUITING
Lille
Hôpital Européen Marseille
NOT_YET_RECRUITING
Marseille
Clinique du Millénaire
NOT_YET_RECRUITING
Montpellier
Hôpital Cochin - AP-HP
RECRUITING
Paris
Hôpital de la Pitié Salpêtrière - AP-HP
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Toulouse
NOT_YET_RECRUITING
Toulouse
Centre Hospitalier Bretagne Atlantique
RECRUITING
Vannes
Centre Hospitalier Verdun
NOT_YET_RECRUITING
Verdun
Contact Information
Primary
Alexis TOULLEC
clinical@biosency.com
02 21 65 70 01
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2027-12
Participants
Target number of participants: 380
Treatments
No_intervention: Control group
Conventional follow-up: 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 SAH and SPLF.
Experimental: Experimental group
Patients will receive conventional clinical follow-up and at the same time benefit from the Bora care remote monitoring system. Patients are monitored daily remotely by Case Managers, who, when the BVS3-3 alarm is triggered on Bora Connect, call the patient to inform the patient about his symptoms, then notify 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 at 48h and 96h if necessary and forwards the information to the pulmonologist.
Sponsors
Collaborators: Assistance Publique - Hôpitaux de Paris
Leads: Biosency

This content was sourced from clinicaltrials.gov