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

NCT06523140 | Recruiting

• 1 other identifier: 2023-A02454-41
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 10

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 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

COPD

Keywords

Remote monitoring; COPD; Prevention; Exacerbations; Patient quality of life

Outcome Measures

Primary Outcomes (1)

• Demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations compared to conventional follow-up.

  Number of hospital days for respiratory deterioration per patient over 12 months.

  1 year

Secondary Outcomes (16)

• Evaluate the effect of the device on the number of hospitalizations per patient.

  1 year

• Evaluate the effect of the device on the average length of stay.

  1 year

• Assess the overall quality of life of patients at baseline and at the end of the trial. (1)

  1 year

• Assess the overall quality of life of patients at baseline and at the end of the trial. (2)

  1 year

• Assess the overall quality of life of patients at baseline and at the end of the trial. (3)

  1 year

Study Arms (2)

Control group

NO INTERVENTION

Conventional follow-up: two consultations with the general practitioner and one consultation with the pulmonologist per year. The inclusion and follow-up visit at 12 months by a pulmonologist are consistent with the follow-up of COPD patients in current practice and the recommendations of SAH and SPLF.

Experimental group

EXPERIMENTAL

Patients will receive conventional clinical follow-up and at the same time benefit from the Bora care remote monitoring system. Patients are monitored daily remotely by Case Managers, who, when the BVS3-3 alarm is triggered on Bora Connect, call the patient to inform the patient about his symptoms, then notify the pulmonologist by transmitting the information from Bora Connect and the minutes of the phone call, who, according to conventional management, decides whether or not to hospitalize the patient, or to generate an unscheduled consultation in order to prescribe drug treatment, and/or to prescribe additional examinations, and/or to adapt the patient's oxygen therapy prescription. The Case Manager re-evaluates the situation at 48h and 96h if necessary and forwards the information to the pulmonologist.

Device: Boracare remote monitoring solution

Interventions

Boracare remote monitoring solution DEVICE

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosency: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (10)

CHU de Brest

Brest, Brittany Region, 29200, France

RECRUITING

Centre Hospitalier Bretagne Atlantique

Vannes, Brittany Region, 56000, France

RECRUITING

Centre Hospitalier de Chartres

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

NOT YET RECRUITING

Centre Hospitalier Verdun

Verdun, Grand Est, 55100, France

NOT YET RECRUITING

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

Lille, Hauts-de-France, 59000, France

NOT YET RECRUITING

Clinique du Millénaire

Montpellier, Occitanie, 34000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, Occitanie, 31300, France

NOT YET RECRUITING

Hôpital Européen Marseille

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

NOT YET RECRUITING

Hôpital de la Pitié Salpêtrière - AP-HP

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

NOT YET RECRUITING

Hôpital Cochin - AP-HP

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

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas ROCHE, MD

  Hôpital Cochin, AP-HP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis TOULLEC

CONTACT

02 21 65 70 01; clinical@biosency.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Comparative, superior, randomised, multicentre, two-arm study (experimental group, control group, 1:1 ratio) in open-label, with a pilot phase Control group: Conventional follow-up: two consultations with the general practitioner and one consultation with the pulmonologist per year. The inclusion and follow-up visit at 12 months by a pulmonologist are consistent with the follow-up of COPD patients in current practice and the recommendations of SAH and SPLF. Experimental group: Patients will receive conventional clinical follow-up and at the same time benefit from the Bora care remote monitoring system. Patients are monitored daily remotely by Case Managers, who, when the BVS3-3 alarm is triggered on Bora Connect, call the patient to inform the patient about his symptoms, then notify the pulmonologist by transmitting the information from Bora Connect. The Case Manager re-evaluates the situation at 48h and 96h if necessary and forwards the information to the pulmonologist.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 26, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)