Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Recruiting · NCT06523140 · Interventional (participants receive a specific treatment) · Lead sponsor: Biosency
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
10 locations listed.
- CHU de Brest - Brest, Brittany Region, France
- Centre Hospitalier Bretagne Atlantique - Vannes, Brittany Region, France
- Centre Hospitalier de Chartres - Le Coudray, Centre-Val de Loire, France
- Centre Hospitalier Verdun - Verdun, Grand Est, France
- Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - Lille, Hauts-de-France, France
- Clinique du Millénaire - Montpellier, Occitanie, France
- Centre Hospitalier Universitaire de Toulouse - Toulouse, Occitanie, France
- Hôpital Européen Marseille - Marseille, Provence-Alpes-Côte d'Azur Region, France
- Hôpital de la Pitié Salpêtrière - AP-HP - Paris, Île-de-France Region, France
- Hôpital Cochin - AP-HP - Paris, Île-de-France Region, France