Boracare remote monitoring solution
DeviceBora Band wristband measuring vital signs at home, Bora Connect platform for caregiver visualization and BVS3 early detection of COPD exacerbations
NCT Number: NCT06523140
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
CHU de Brest, Brest, Brittany Region, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bora Band wristband measuring vital signs at home, Bora Connect platform for caregiver visualization and BVS3 early detection of COPD exacerbations
Time frame: 1 year
Number of hospital days for respiratory deterioration per patient over 12 months.
Time frame: 1 year
Number of hospitalizations within 12 months of implementation of Bora Care remote monitoring.
Time frame: 1 year
Average length of stay in hospital within 12 months of the implementation of Bora Care.
Time frame: 1 year
Score from CAT (Chronic Obstructive Pulmonary Disease Assessment Test) questionnaire to assess the quality of life collected at Day 0, M6, M12.
Time frame: 1 year
Score from Short Form 36 (SF36) quality of life assessment questionnaire to assess the quality of life collected at Day 0, M6, M12.
Time frame: 1 year
Score from EXACT E-RS (Evaluating Respiratory Symptoms) symptom assessment questionnaire to assess the quality of life collected at Day 0, M6, M12.
Time frame: 3 years
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.
Time frame: 3 years
Number and nature of emergency, resuscitation, consultations and teleconsultations with the pulmonologist or attending physician.
Time frame: 3 years
Duration of emergency, resuscitation, consultations and teleconsultations with the pulmonologist or attending physician.
Time frame: 3 years
Number and nature of follow-up examinations and new pathologies detected during follow-up.
Time frame: 3 years
Number and nature of prescribed pharmacological treatments and prescribed oxygen therapy.
Time frame: 3 years
Duration of prescribed pharmacological treatments and prescribed oxygen therapy.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 3 years
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.
Time frame: 3 years
Alert performance in detecting exacerbations and other medical events by calculating alert sensitivity and specificity.
Contact information is provided by the study sponsor or research team.
Biosency
Industry
Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Acronym: AUSTRAAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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