NCT06523140Recruiting
Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 8 Jul 2024
- Start date
- 20 Nov 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Biosency
- Diseases
- COPD
- NCT number
- NCT06523140
What you commit to
- Study type: Interventional
- Planned participants: 380
- From 20 Nov 2024 to the primary completion date, Dec 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Hospitalier de Chartres Coordinator of this site? Confirm its status | Le Coudray | France | Not yet recruiting |
| Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Clinique du Millenaire Coordinator of this site? Confirm its status | Montpellier | France | Not yet recruiting |
| Hôpital Cochin AP-HP Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital de la Pitié Salpêtrière - AP-HP Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Centre Hospitalier Bretagne Atlantique Coordinator of this site? Confirm its status | Vannes | France | Recruiting |
| Centre Hospitalier Verdun Coordinator of this site? Confirm its status | Verdun | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.