Remote monitoring for COPD patients using BoraCare
Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
This study is testing if using the BoraCare remote monitoring system can help people with COPD stay out of the hospital longer compared to just regular check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biosency Industry-sponsored |
| Locations | 10 sites (Brest, Brittany Region and 9 other locations) |
| Trial ID | NCT06523140 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the BoraCare remote monitoring solution in managing COPD patients who frequently experience exacerbations. Participants will be divided into two groups: one receiving conventional follow-up care and the other receiving both conventional care and the BoraCare system, which includes a wristband for vital sign monitoring and a platform for data visualization by caregivers. The primary goal is to determine if remote monitoring can reduce the average annual length of hospitalization due to COPD exacerbations over a 12-month period. The study will involve regular consultations with healthcare professionals and daily monitoring by trained case managers.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a history of COPD exacerbations and stable respiratory function.
Not a fit: Patients with unstable comorbidities, psychological frailties, or those who do not speak French may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospitalizations for COPD patients, improving their quality of life.
How similar studies have performed: Other studies have shown promise in using remote monitoring for chronic conditions, suggesting potential success for this approach in COPD management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Brest, Brittany Region and 9 other locations
- CHU de Brest — Brest, Brittany Region, France (Recruiting)
- Centre Hospitalier Bretagne Atlantique — Vannes, Brittany Region, France (Recruiting)
- Centre Hospitalier de Chartres — Le Coudray, Centre-Val de Loire, France (Not_yet_recruiting)
- Centre Hospitalier Verdun — Verdun, Grand Est, France (Not_yet_recruiting)
- Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) — Lille, Hauts-de-France, France (Not_yet_recruiting)
- Clinique du Millénaire — Montpellier, Occitanie, France (Not_yet_recruiting)
- Centre Hospitalier Universitaire de Toulouse — Toulouse, Occitanie, France (Not_yet_recruiting)
- Hôpital Européen Marseille — Marseille, Provence-Alpes-Côte d'Azur Region, France (Not_yet_recruiting)
- Hôpital de la Pitié Salpêtrière - AP-HP — Paris, Île-de-France Region, France (Not_yet_recruiting)
- Hôpital Cochin - AP-HP — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Nicolas ROCHE, MD — Hôpital Cochin, AP-HP
- Study coordinator: Alexis TOULLEC
- Email: clinical@biosency.com
- Phone: 02 21 65 70 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.