Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06523140

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

Led by Biosency · Updated on 2025-08-22

380

Participants Needed

10

Research Sites

158 weeks

Total Duration

On this page

Sponsors

B

Biosency

Lead Sponsor

A

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years of age with COPD diagnosed following SPLF guidelines and known respiratory function measured within the last 12 months
  • Patient hospitalized for COPD exacerbation in the past 12 months
  • Patient who has given informed consent
  • Patient enrolled in a social security scheme (Art L1121-11 of the CSP)
Not Eligible

You will not qualify if you...

  • Presence of an unstable or very severe comorbidity as judged by the investigator
  • Patient with psychological frailties
  • Patient currently enrolled in another interventional trial
  • Patient who does not speak French and cannot use the Bora Band or lacks a caregiver to assist
  • Patient under guardianship or unable to provide free and informed consent
  • Pregnant or nursing women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

CHU de Brest

Brest, Brittany Region, France, 29200

Actively Recruiting

2

Centre Hospitalier Bretagne Atlantique

Vannes, Brittany Region, France, 56000

Actively Recruiting

3

Centre Hospitalier de Chartres

Le Coudray, Centre-Val de Loire, France, 28630

Not Yet Recruiting

4

Centre Hospitalier Verdun

Verdun, Grand Est, France, 55100

Not Yet Recruiting

5

Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

Lille, Hauts-de-France, France, 59000

Not Yet Recruiting

6

Clinique du Millénaire

Montpellier, Occitanie, France, 34000

Not Yet Recruiting

7

Centre Hospitalier Universitaire de Toulouse

Toulouse, Occitanie, France, 31300

Not Yet Recruiting

8

Hôpital Européen Marseille

Marseille, Provence-Alpes-Côte d'Azur Region, France, 13003

Not Yet Recruiting

9

Hôpital de la Pitié Salpêtrière - AP-HP

Paris, Île-de-France Region, France, 75013

Not Yet Recruiting

10

Hôpital Cochin - AP-HP

Paris, Île-de-France Region, France, 75014

Actively Recruiting

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Research Team

A

Alexis TOULLEC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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