Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523140
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Management of COPD Patients With BoraCare Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Management of Chronic Obstructive Pulmonary Disease COPD Patients With BoraCare Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUSTRAAL
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
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 andor to prescribe additional examinations andor to adapt the patients 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
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 andor to prescribe additional examinations andor to adapt the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None