RecruitingNot ApplicableNCT06523140

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

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


Sponsor

Biosency

Enrollment

380 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

Interventions

DEVICEBoracare remote monitoring solution

Bora Band wristband measuring vital signs at home, Bora Connect platform for caregiver visualization and BVS3 early detection of COPD exacerbations


Locations(10)

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

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NCT06523140


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