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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: BORA Band (wristband)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BORA Band (wristband)|Wristband collecting patient vital signs and activity|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between AECOPD and measured parameters | Correlation between measured parameters and observed AECOPD events | 12 months | 
| Compliance | Wristband wearing duration during the follow-up period | 12 months | 
| Description of AECOPD | Number, duration, severity of AECOPD events observed during the study | 12 months | 
| 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 | 
| 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 | 
| Satisfaction | meCUE questionnaire after 12 months | 12 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, acute exacerbation, prevention, early detection