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

Plain Language Summary

Simplified for easier understanding

This trial is testing a remote monitoring wristband device called BoraCare® (with BVS3 scoring) to detect early signs of COPD flare-ups before they become severe, helping patients manage their condition at home. **You may be eligible if...** - You are over 18 with a confirmed diagnosis of COPD - You have been hospitalized for a COPD exacerbation (flare-up) in the past 12 months - Your baseline lung function test has been done in the past 12 months - You are being seen in a pulmonology clinic - You speak French and are able to use the BoraCare device - You have signed informed consent and are enrolled in French social security **You may NOT be eligible if...** - You have another serious unstable medical condition - You have significant psychological fragility - You are already in another interventional clinical trial - You do not speak French and don't have a caregiver to assist - You are under legal guardianship or unable to give free consent - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT06523140


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