Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease (BOREAL)

NCT ID: NCT05759247

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-19
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to evaluate the ability of the Bora Care remote monitoring solution to detect early acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

Worldwide, COPD has been increasing for 20 years with nearly 300 million patients, i.e. 4 to 10% of the adult population (7.5% in France). According to the WHO, it is now the fourth leading cause of death in the world.

Acute exacerbations of COPD (worsening of symptoms requiring an increase in treatment) represent frequent events in the course of the disease and the consequences are significant for the patient in terms of vital prognosis, deterioration of respiratory function, impact on quality life and for the health system in terms of cost. Missed diagnosis and delayed treatment are associated with impaired outcomes. The prevention and early treatment of acute exacerbations of COPD therefore have a major role in the management of COPD patients and could be facilitated by telemonitoring tools.

The purpose of the present study is to validate the interest of remote monitoring of various parameters (cardio-respiratory, environmental, symptom questionnaires) to predict and detect early the occurrence of acute exacerbations of COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

BORA Band (wristband)

Wristband collecting patient vital signs and activity

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient with COPD defined according to the SPLF recommendations, whose level of lung function in a stable state is known (measurement less than 12 months old)
• Patient with at least one of the following criteria :

• Hospitalized for a COPD exacerbation at the time of enrolment in the study, and having had at least one other exacerbation in the last 12 months
• Followed-up and part of the active file of the site, having had at least 2 exacerbations during the last 12 months, including one with hospitalization
• COPD patient with at least 2 exacerbations in the last 12 months, including one with hospitalization
• Patient having given written informed consent to participate in the study
• Patient affiliated to the French social security system

Exclusion Criteria

• Vulnerable patient (minor, protected adult, prisoner)
• Patient unable to use the BoraBand tool and without access to a caregiver
• Presence of a comorbidity considered unstable or very severe by the investigator
• Patient already participating in another interventional research study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosency

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas ROCHE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Pneumology Department - Hôpital Cochin

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas ROCHE, MD, PhD

Role: CONTACT

nicolas.roche@aphp.fr

01 58 41 21 53

Christelle AUGER

Role: CONTACT

christelle.auger@aphp.fr

01 58 41 11 86

Facility Contacts

Nicolas ROCHE, MD, PhD

Role: primary

nicolas.roche@aphp.fr

01 58 41 21 53

Christelle AUGER

Role: backup

christelle.auger@aphp.fr

01 58 41 11 86

Other Identifiers

2021-A02146-35

Identifier Type: OTHER

Identifier Source: secondary_id

APHP211098

Identifier Type: -

Identifier Source: org_study_id