COPDAUSTRAALNCT06523140
Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
A study testing Boracare remote monitoring solution in people with COPD, run by Biosency at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Boracare remote monitoring solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 10 sitesFrance
- Study dates
- 20 Nov 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU de Brest
Brest, Brittany Region, 29200
02 98 22 33 33 ext. +33
Christophe GUT GOBERT, MD
- Not yet recruiting
Centre Hospitalier de Chartres
Le Coudray, Centre-Val de Loire, 28630
02 37 30 30 30 ext. +33
Anissa BERRAIES, MD
- Not yet recruiting
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Lille, Hauts-de-France, 59000
03 20 22 50 54 ext. +33
Arnaud CHAMBELLAN, MD
- Not yet recruiting
Hôpital Européen Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, 13003
04 13 427 000 ext. +33
Hervé PEGLIASCO, MD
- Not yet recruiting
Clinique du Millénaire
Montpellier, Occitanie, 34000
04 99 53 60 00 ext. +33
François BUGHIN, MD
- Not yet recruiting
Hôpital de la Pitié Salpêtrière - AP-HP
Paris, Île-de-France Region, 75013
01 42 16 00 00 ext. +33
Jesus GONZALEZ, MD
- Recruiting
Hôpital Cochin - AP-HP
Paris, Île-de-France Region, 75014
01 58 41 21 53 ext. +33
Nicolas ROCHE, MD
- Not yet recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse, Occitanie, 31300
05 61 77 22 33 ext. +33
Sandrine PONTIER, MD
- Recruiting
Centre Hospitalier Bretagne Atlantique
Vannes, Brittany Region, 56000
02 97 01 41 41 ext. +33
Tiphaine GUY, MD
- Not yet recruiting
Centre Hospitalier Verdun
Verdun, Grand Est, 55100
03 29 83 84 85 ext. +33
Jean Claude CORNU, MD
About this study
Official title: 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.
Read the 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).
- Conditions
- COPD
- Being tested
- Boracare remote monitoring solution
- Keywords
- Remote monitoring, COPD, Prevention, Exacerbations, Patient quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boracare remote monitoring solutionDevice
Bora Band wristband measuring vital signs at home, Bora Connect platform for caregiver visualization and BVS3 early detection of COPD exacerbations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Boracare remote monitoring solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Assess the impact of the device on the quality of support. (3)
Duration of prescribed pharmacological treatments and prescribed oxygen therapy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start20 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosency
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MD, Principal investigator, Hôpital Cochin, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523140
- Sponsor's protocol ID
- 2023-A02454-41
- Acronym
- AUSTRAAL
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. Data are not intended to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
- ClinicalTrials.gov ID
- NCT06523140
- Acronym / sponsor ID
- AUSTRAAL / 2023-A02454-41
- Conditions
- COPD
- Keywords
- Remote monitoring, COPD, Prevention, Exacerbations, Patient quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- BiosencyIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Boracare remote monitoring solutionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boracare remote monitoring solutionBora Band wristband measuring vital signs at home, Bora Connect platform for caregiver visualization and BVS3 early detection of COPD exacerbations | Device | Experimental group |
Primary outcome
Demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations compared to conventional follow-up.
Time frame: 1 year
Number of hospital days for respiratory deterioration per patient over 12 months.
16 secondary outcomes
Evaluate the effect of the device on the number of hospitalizations per patient.
Time frame: 1 year
Evaluate the effect of the device on the average length of stay.
Time frame: 1 year
Assess the overall quality of life of patients at baseline and at the end of the trial. (1)
Time frame: 1 year
Assess the overall quality of life of patients at baseline and at the end of the trial. (2)
Time frame: 1 year
Assess the overall quality of life of patients at baseline and at the end of the trial. (3)
Time frame: 1 year
Assess the conformity of use of the Bora Care device.
Time frame: 3 years
Assess the impact of the device on the organisation of care. (1)
Time frame: 3 years
Assess the impact of the device on the organisation of care. (2)
Time frame: 3 years
Assess the impact of the device on the organisation of care. (3)
Time frame: 3 years
Assess the impact of the device on the quality of support. (1)
Time frame: 3 years
Assess the impact of the device on the quality of support. (3)
Time frame: 3 years
Assess patient and caregiver satisfaction with the device. (1)
Time frame: 1 year
Assess patient and caregiver satisfaction with the device. (2)
Time frame: 1 year
Assess patient and caregiver satisfaction with the device. (3)
Time frame: 1 year
Evaluate the performance of the warning device in the early detection of exacerbations.
Time frame: 3 years
Identify new markers of exacerbations or other clinical events.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No. Not applicable. Data are not intended to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas ROCHE, MD principal investigator
Hôpital Cochin, AP-HP
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boracare remote monitoring solution in people with COPD, run by Biosency at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis TOULLEC (02 21 65 70 01 ext. +33, clinical@biosency.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations compared to conventional follow-up. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.