RecruitingRecruiting
Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
NCT06523140 · Biosency
In plain English
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Official title
Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
About this study
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).
Eligibility criteria
Inclusion Criteria:
* 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)
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 and without access to a caregiver,
* Patient protected under guardianship or unable to give free and informed consent.
* Pregnant or nursing woman
Study design
Enrollment target: 380 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-20
Estimated completion: 2027-12
Last updated: 2025-08-22
Interventions
Device: Boracare remote monitoring solution
Primary outcomes
- • Demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations compared to conventional follow-up. (1 year)
Sponsor
Biosency · industry
With: Assistance Publique - Hôpitaux de Paris
Contacts & investigators
ContactAlexis TOULLEC · contact · clinical@biosency.com · 02 21 65 70 01
InvestigatorNicolas ROCHE, MD · principal_investigator, Hôpital Cochin, AP-HP
All locations (10)
CHU de BrestRecruiting
Brest, Brittany Region, France
Centre Hospitalier Bretagne AtlantiqueRecruiting
Vannes, Brittany Region, France
Centre Hospitalier de ChartresNot Yet Recruiting
Le Coudray, Centre-Val de Loire, France
Centre Hospitalier VerdunNot Yet Recruiting
Verdun, Grand Est, France
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)Not Yet Recruiting
Lille, Hauts-de-France, France
Clinique du MillénaireNot Yet Recruiting
Montpellier, Occitanie, France
Centre Hospitalier Universitaire de ToulouseNot Yet Recruiting
Toulouse, Occitanie, France
Hôpital Européen MarseilleNot Yet Recruiting
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hôpital de la Pitié Salpêtrière - AP-HPNot Yet Recruiting
Paris, Île-de-France Region, France
Hôpital Cochin - AP-HPRecruiting
Paris, Île-de-France Region, France