Pneumology Department - Hôpital Cochin
Paris, 75014, France
NCT Number: NCT05759247
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wristband collecting patient vital signs and activity
Time frame: 12 months
Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study
Time frame: 12 months
Correlation between measured parameters and observed AECOPD events
Time frame: 12 months
Wristband wearing duration during the follow-up period
Time frame: 12 months
Number, duration, severity of AECOPD events observed during the study
Time frame: 12 months
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)
Time frame: 12 months
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)
Time frame: 12 months
meCUE questionnaire after 12 months
Time frame: 12 months
EXASCORE questionnaire at baseline and after 6 and 12 months. EXASCORE: 2 dimensions, 8 items, range 0-32 (the highest the worst)
Time frame: 12 months
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)
Assistance Publique - Hôpitaux de Paris
Other
Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease
Acronym: BOREAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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