Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
NCT Number: NCT06523140
Acronym: AUSTRAAL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: COPD
Interventions: DEVICE: Boracare remote monitoring solution
Sponsor: Biosency
Collaborators: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2027-12
Locations: Hôpital Cochin - AP-HP, Paris, 75014, France

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.

Primary Outcome Measures: 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: 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