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

NCT05759247 | Active Not Recruiting

• 2 other identifiers: APHP2110982021-A02146-35
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; acute exacerbation; prevention; early detection

Outcome Measures

Primary Outcomes (1)

• Performance of the device for early detection of AECOPD

  Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study

  12 months

Secondary Outcomes (8)

• Relation between AECOPD and measured parameters

  12 months

• Compliance

  12 months

• Description of AECOPD

  12 months

• Quality of Life CAT

  12 months

• Quality of Life EQ5D5L

  12 months

Interventions

BORA Band (wristband) DEVICE

Wristband collecting patient vital signs and activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Biosency: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Pneumology Department - Hôpital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas ROCHE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: March 8, 2023
• Study Start: June 19, 2023
• Primary Completion: January 29, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)