Clinical trial NCT05759247: Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease (BOREAL)
Official title: Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
acute exacerbation
prevention
early detection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Biosency
First posted: 2023-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Performance of the device for early detection of AECOPD
timeFrame: 12 months
Secondary outcomes:
measure: Relation between AECOPD and measured parameters
timeFrame: 12 months
measure: Compliance
timeFrame: 12 months
measure: Description of AECOPD
timeFrame: 12 months
measure: Quality of Life CAT
timeFrame: 12 months
measure: Quality of Life EQ5D5L
timeFrame: 12 months
measure: Satisfaction
timeFrame: 12 months
measure: Symptoms - EXASCORE questionnaire
timeFrame: 12 months
measure: Symptoms - EXACT E-RS questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Pneumology Department - Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas ROCHE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: