Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Performance of the device for early detection of AECOPD
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Performance of the device for early detection of AECOPD
Time Frame: 12 months
Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study
Secondary Outcomes
- Relation between AECOPD and measured parameters(12 months)
- Compliance(12 months)
- Symptoms - EXACT E-RS questionnaire(12 months)
- Description of AECOPD(12 months)
- Quality of Life CAT(12 months)
- Quality of Life EQ5D5L(12 months)
- Satisfaction(12 months)
- Symptoms - EXASCORE questionnaire(12 months)