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

Chronic Obstructive Pulmonary Disease Clinical Trial

— BOREAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759247
• Other study ID #: APHP211098
• Secondary ID: 2021-A02146-35
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nicolas ROCHE, MD, PhD
• Phone: 01 58 41 21 53
• Email: nicolas.roche[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• BORA Band (wristband)
Wristband collecting patient vital signs and activity

Locations

Country	Name	City	State
France	Pneumology Department - Hôpital Cochin	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Biosency

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relation between AECOPD and measured parameters	Correlation between measured parameters and observed AECOPD events	12 months
Secondary	Compliance	Wristband wearing duration during the follow-up period	12 months
Secondary	Description of AECOPD	Number, duration, severity of AECOPD events observed during the study	12 months
Secondary	Quality of Life CAT	Quality of life questionnaire CAT at baseline and after 6 and 12 months - CAT : COPD Assement Test, 8 items, range 0 (no impact of COPD) - 40 (worst impact of COPD)	12 months
Secondary	Quality of Life EQ5D5L	Quality of life questionnaire EQ5D5L at baseline and after 6 and 12 months - EQ5S5L : five dimensions, 5 levels each, final result expressed as a 5-digit number that describes the patient's health state (worsens with increasing score)	12 months
Secondary	Satisfaction	meCUE questionnaire after 12 months	12 months
Secondary	Symptoms - EXASCORE questionnaire	EXASCORE questionnaire at baseline and after 6 and 12 months. EXASCORE: 2 dimensions, 8 items, range 0-32 (the highest the worst)	12 months
Secondary	Symptoms - EXACT E-RS questionnaire	EXACT E-RS questionnaire at baseline and after 6 and 12 months. EXACT E-RS : 4 sections, 14 items, range 0-100 (the highest the worst)	12 months