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L'essai clinique NCT06523140 (AUSTRAAL) pour BPCO est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations (AUSTRAAL)
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L'étude clinique NCT06523140 (AUSTRAAL) est un essai interventionnel pour BPCO. Son statut actuel est : en recrutement. L'étude a débuté le 20 novembre 2024 et vise à recruter 380 participants. Dirigé par Biosency, l'essai devrait être terminé d'ici le 1 décembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 22 août 2025.
Résumé succinct
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.
Description détaillée
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).
Titre officiel
Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Conditions
BPCOAutres identifiants de l'essai
- AUSTRAAL
- 2023-A02454-41
Numéro NCT
Date de début (réel)
2024-11-20
Dernière mise à jour publiée
2025-08-22
Date de fin (estimée)
2027-12
Inscription (estimée)
380
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Remote monitoring
COPD
Prevention
Exacerbations
Patient quality of life
COPD
Prevention
Exacerbations
Patient quality of life
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Aucune interventionControl 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. | N/A |
ExpérimentalExperimental 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. | 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 |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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)
- 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
BiosencyAssistance publique - Hôpitaux de ParisContact central de l'essai
Contact: Alexis TOULLEC, 02 21 65 70 01, [email protected]
10 Centres de l'essai dans 1 pays
Brittany Region
CHU de Brest, Brest, Brittany Region, 29200, France
Contact, 02 98 22 33 33
Christophe GUT GOBERT, MD, Investigateur principal
En recrutement
Centre Hospitalier Bretagne Atlantique, Vannes, Brittany Region, 56000, France
Contact, 02 97 01 41 41
Tiphaine GUY, MD, Investigateur principal
En recrutement
Centre-Val de Loire
Centre Hospitalier de Chartres, Le Coudray, Centre-Val de Loire, 28630, France
Contact, 02 37 30 30 30
Anissa BERRAIES, MD, Investigateur principal
Pas encore en recrutement
Grand Est
Centre Hospitalier Verdun, Verdun, Grand Est, 55100, France
Contact, 03 29 83 84 85
Jean Claude CORNU, MD, Investigateur principal
Pas encore en recrutement
Hauts-de-France
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL), Lille, Hauts-de-France, 59000, France
Contact, 03 20 22 50 54
Arnaud CHAMBELLAN, MD, Investigateur principal
Pas encore en recrutement
Occitanie
Clinique du Millénaire, Montpellier, Occitanie, 34000, France
Contact, 04 99 53 60 00
François BUGHIN, MD, Investigateur principal
Pas encore en recrutement
Centre Hospitalier Universitaire de Toulouse, Toulouse, Occitanie, 31300, France
Contact, 05 61 77 22 33
Sandrine PONTIER, MD, Investigateur principal
Pas encore en recrutement
Provence-Alpes-Côte d'Azur Region
Hôpital Européen Marseille, Marseille, Provence-Alpes-Côte d'Azur Region, 13003, France
Contact, 04 13 427 000
Hervé PEGLIASCO, MD, Investigateur principal
Pas encore en recrutement
Île-de-France Region
Hôpital de la Pitié Salpêtrière - AP-HP, Paris, Île-de-France Region, 75013, France
Contact, 01 42 16 00 00
Jesus GONZALEZ, MD, Investigateur principal
Pas encore en recrutement
Hôpital Cochin - AP-HP, Paris, Île-de-France Region, 75014, France
Contact, 01 58 41 21 53
Nicolas ROCHE, MD, Investigateur principal
En recrutement