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NCT Number: NCT05759247

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pneumology Department - Hôpital Cochin

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BORA Band (wristband)

Device

Wristband collecting patient vital signs and activity

Primary outcomes

  1. 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

  1. Relation between AECOPD and measured parameters

    Time frame: 12 months

    Correlation between measured parameters and observed AECOPD events

  2. Compliance

    Time frame: 12 months

    Wristband wearing duration during the follow-up period

  3. Description of AECOPD

    Time frame: 12 months

    Number, duration, severity of AECOPD events observed during the study

  4. Quality of Life CAT

    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)

  5. Quality of Life EQ5D5L

    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)

  6. Satisfaction

    Time frame: 12 months

    meCUE questionnaire after 12 months

  7. Symptoms - EXASCORE questionnaire

    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)

  8. Symptoms - EXACT E-RS questionnaire

    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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Biosency
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: BOREAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Apr 23, 2026

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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