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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Device: Boracare remote monitoring solution

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 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 HAS (National Authority for Health) and SPLF (French-Language Society of Pneumology).

Experimental group (conventional monitoring + remote monitoring):

The patients will be subject to conventional clinical follow-up and at the same time benefit from the Bora care remote monitoring system. The Bora care remote monitoring system includes a BoraBand wristband measuring vital signs at home, the Bora Connect platform for caregiver visualization of data and the BVS3 score for early detection of COPD exacerbations. Patients are monitored daily remotely by Case Managers (nurses trained in Bora Care solution), who, when the BVS3 > 3 alert is triggered on Bora Connect, call the patient to inform the patient about his symptoms, then alert 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 after 48 hours and 96 hours if necessary and forwards the information to the pulmonologist. The nature of the transmission of information (telephone or email) between the Case Manager and the pulmonologist in case of an alert is defined when the patient is included by the pulmonologist. If desired, remotely monitored patients will be able to access the Bora Connect interface provided for patients (restricted viewing of data).

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexis TOULLEC; Phone Number: +33 02 21 65 70 01; Email: clinical@biosency.com

Study Locations

• France
  • Bretagne
    • Brest, Bretagne, France, 29200
      • Recruiting
      • CHU de Brest
      • Contact: Phone Number: +33 02 98 22 33 33
      • Principal Investigator: Christophe GUT GOBERT, MD
    • Vannes, Bretagne, France, 56000
      • Recruiting
      • Centre Hospitalier Bretagne Atlantique
      • Contact: Phone Number: +33 02 97 01 41 41
      • Principal Investigator: Tiphaine GUY, MD
  • Centre-Val de Loire
    • Le Coudray, Centre-Val de Loire, France, 28630
      • Not yet recruiting
      • Centre Hospitalier de Chartres
      • Contact: Phone Number: +33 02 37 30 30 30
      • Principal Investigator: Anissa BERRAIES, MD
  • Grand Est
    • Verdun, Grand Est, France, 55100
      • Not yet recruiting
      • Centre Hospitalier Verdun
      • Contact: Phone Number: +33 03 29 83 84 85
      • Principal Investigator: Jean Claude CORNU, MD
  • Hauts-de-France
    • Lille, Hauts-de-France, France, 59000
      • Not yet recruiting
      • Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
      • Principal Investigator: Arnaud CHAMBELLAN, MD
      • Contact: Phone Number: +33 03 20 22 50 54
  • Ile-de-France
    • Paris, Ile-de-France, France, 75013
      • Not yet recruiting
      • Hôpital de la Pitié Salpêtrière - AP-HP
      • Principal Investigator: Jesus GONZALEZ, MD
      • Contact: Phone Number: +33 01 42 16 00 00
    • Paris, Ile-de-France, France, 75014
      • Recruiting
      • Hôpital Cochin - AP-HP
      • Principal Investigator: Nicolas Roche, MD
      • Contact: Phone Number: +33 01 58 41 21 53
  • Occitanie
    • Montpellier, Occitanie, France, 34000
      • Not yet recruiting
      • Clinique du Millénaire
      • Principal Investigator: François Bughin, MD
      • Contact: Phone Number: +33 04 99 53 60 00
    • Toulouse, Occitanie, France, 31300
      • Not yet recruiting
      • Centre Hospitalier Universitaire de Toulouse
      • Contact: Phone Number: +33 05 61 77 22 33
      • Principal Investigator: Sandrine PONTIER, MD
  • Provence-Alpes-Côte d'Azur
    • Marseille, Provence-Alpes-Côte d'Azur, France, 13003
      • Not yet recruiting
      • Hôpital Européen Marseille
      • Contact: Phone Number: +33 04 13 427 000
      • Principal Investigator: Hervé PEGLIASCO, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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: 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 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; Bora Band wristband measuring vital signs at home, Bora Connect platform for caregiver visualization and BVS3 early detection of COPD exacerbations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect of the device on the number of hospitalizations per patient.	Number of hospitalizations within 12 months of implementation of Bora Care remote monitoring.	1 year
Evaluate the effect of the device on the average length of stay.	Average length of stay in hospital within 12 months of the implementation of Bora Care.	1 year
Assess the overall quality of life of patients at baseline and at the end of the trial. (1)	Score from CAT (Chronic Obstructive Pulmonary Disease Assessment Test) questionnaire to assess the quality of life collected at Day 0, M6, M12.	1 year
Assess the overall quality of life of patients at baseline and at the end of the trial. (2)	Score from Short Form 36 (SF36) quality of life assessment questionnaire to assess the quality of life collected at Day 0, M6, M12.	1 year
Assess the overall quality of life of patients at baseline and at the end of the trial. (3)	Score from EXACT E-RS (Evaluating Respiratory Symptoms) symptom assessment questionnaire to assess the quality of life collected at Day 0, M6, M12.	1 year
Assess the conformity of use of the Bora Care device.	Number of hours spent wearing the Bora Connect bracelet normalized by the total number of hours spent in the remote monitoring session, information collected via the Bora Care tool.	3 years
Assess the impact of the device on the organisation of care. (1)	Number and nature of emergency, resuscitation, consultations and teleconsultations with the pulmonologist or attending physician.	3 years
Assess the impact of the device on the organisation of care. (2)	Duration of emergency, resuscitation, consultations and teleconsultations with the pulmonologist or attending physician.	3 years
Assess the impact of the device on the organisation of care. (3)	Number and nature of follow-up examinations and new pathologies detected during follow-up.	3 years
Assess the impact of the device on the quality of support. (1)	Number and nature of prescribed pharmacological treatments and prescribed oxygen therapy.	3 years
Assess the impact of the device on the quality of support. (3)	Duration of prescribed pharmacological treatments and prescribed oxygen therapy.	3 years
Assess patient and caregiver satisfaction with the device. (1)	Subjective assessment by the patient of the device, the reassurance provided by the device, the assistance to resume physical activity provided by the device, obtained using satisfaction questionnaires at M6 and M12.	1 year
Assess patient and caregiver satisfaction with the device. (2)	Subjective assessment by the patient of the overall quality of follow-up obtained using a detailed questionnaire (Likert scale) and an open-ended question about possible improvements at M6 and M12.	1 year
Assess patient and caregiver satisfaction with the device. (3)	Subjective assessment by caregivers of the Bora Care solution's impact on patient care using questions about organizational impacts and improved quality of care provided by the device, obtained using a satisfaction questionnaire at M6 and M12.	1 year
Evaluate the performance of the warning device in the early detection of exacerbations.	The number and nature of the alerts issued by the Bora Care solution, the number and nature of the actions taken following the alert specified in the alert management tool in the Bora Connect tool.	3 years
Identify new markers of exacerbations or other clinical events.	Alert performance in detecting exacerbations and other medical events by calculating alert sensitivity and specificity.	3 years

Collaborators and Investigators

• Sponsor: Biosency
• Collaborators: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nicolas ROCHE, MD, Hôpital Cochin, AP-HP

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Prevention; Exacerbations; Remote monitoring; Patient quality of life
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2023-A02454-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not applicable. Data are not intended to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No