Status:
RECRUITING
Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Lead Sponsor:
Biosency
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
COPD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 con...
Detailed 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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT06523140
Start Date
November 20 2024
End Date
December 1 2027
Last Update
August 22 2025
Active Locations (10)
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1
CHU de Brest
Brest, Brittany Region, France, 29200
2
Centre Hospitalier Bretagne Atlantique
Vannes, Brittany Region, France, 56000
3
Centre Hospitalier de Chartres
Le Coudray, Centre-Val de Loire, France, 28630
4
Centre Hospitalier Verdun
Verdun, Grand Est, France, 55100