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

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05759247
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Study Start: 2023-06-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance of the device for early detection of AECOPD	12 months	Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study

Secondary Outcome Measures

Name	Time	Method
Relation between AECOPD and measured parameters	12 months	Correlation between measured parameters and observed AECOPD events
Compliance	12 months	Wristband wearing duration during the follow-up period
Symptoms - EXACT E-RS questionnaire	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)
Description of AECOPD	12 months	Number, duration, severity of AECOPD events observed during the study
Quality of Life CAT	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)
Quality of Life EQ5D5L	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)
Satisfaction	12 months	meCUE questionnaire after 12 months
Symptoms - EXASCORE questionnaire	12 months	EXASCORE questionnaire at baseline and after 6 and 12 months. EXASCORE: 2 dimensions, 8 items, range 0-32 (the highest the worst)

Trial Locations

Locations (1)

Pneumology Department - Hôpital Cochin; 🇫🇷 Paris, France