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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BORA Band (wristband)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, acute exacerbation, prevention, early detection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pneumology Department - Hôpital Cochin

Outcomes

Primary Outcome Measures

Performance of the device for early detection of AECOPD
Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study

Secondary Outcome Measures

Relation between AECOPD and measured parameters
Correlation between measured parameters and observed AECOPD events
Compliance
Wristband wearing duration during the follow-up period
Description of AECOPD
Number, duration, severity of AECOPD events observed during the study
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)
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)
Satisfaction
meCUE questionnaire after 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)
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)

Full Information

First Posted
January 19, 2023
Last Updated
March 6, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Biosency
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1. Study Identification

Unique Protocol Identification Number
NCT05759247
Brief Title
Evaluation of the Use of a Remote Monitoring and Follow-up Option for Patients With Chronic Obstructive Pulmonary Disease (BOREAL)
Acronym
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Biosency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, acute exacerbation, prevention, early detection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
BORA Band (wristband)
Intervention Description
Wristband collecting patient vital signs and activity
Primary Outcome Measure Information:
Title
Performance of the device for early detection of AECOPD
Description
Sensibility and specificity of the alerts computed for all AECOPD event recorded in the study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Relation between AECOPD and measured parameters
Description
Correlation between measured parameters and observed AECOPD events
Time Frame
12 months
Title
Compliance
Description
Wristband wearing duration during the follow-up period
Time Frame
12 months
Title
Description of AECOPD
Description
Number, duration, severity of AECOPD events observed during the study
Time Frame
12 months
Title
Quality of Life CAT
Description
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
Title
Quality of Life EQ5D5L
Description
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
Title
Satisfaction
Description
meCUE questionnaire after 12 months
Time Frame
12 months
Title
Symptoms - EXASCORE questionnaire
Description
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
Title
Symptoms - EXACT E-RS questionnaire
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas ROCHE, MD, PhD
Phone
01 58 41 21 53
Email
nicolas.roche@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle AUGER
Phone
01 58 41 11 86
Email
christelle.auger@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas ROCHE, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pneumology Department - Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas ROCHE, MD, PhD
Phone
01 58 41 21 53
Email
nicolas.roche@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christelle AUGER
Phone
01 58 41 11 86
Email
christelle.auger@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nicolas ROCHE, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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