Menu
Recruiting NCT06523140

Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations

No phase Interventional COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Boracare remote monitoring solution.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations

Overview

The goal of this clinical trial is to demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations (experimental group) compared to conventional follow-up alone (control group) on the total number of hospital days per patient for respiratory deterioration over 12 months of follow-up. The main question it aims to answer is: Does remote monitoring of COPD patients reduce the average annual length of hospitalization for exacerbations of COPD patients? All participants will benefit a conventional clinical follow-up. Participants in experimental group will also benefit from the Bora care remote monitoring system.

Detailed description

Control group (control): conventional follow-up For the target population (frequent exacerbating COPD patients), the usual follow-up includes two consultations with the general practitioner and one consultation with the pulmonologist per year. The inclusion and follow-up visit at 12 months by a pulmonologist are consistent with the follow-up of COPD patients in current practice and the recommendations of HAS (National Authority for Health) and SPLF (French-Language Society of Pneumology).

Experimental group (conventional monitoring + remote monitoring):

The patients will be subject to conventional clinical follow-up and at the same time benefit from the Bora care remote monitoring system. The Bora care remote monitoring system includes a BoraBand wristband measuring vital signs at home, the Bora Connect platform for caregiver visualization of data and the BVS3 score for early detection of COPD exacerbations. Patients are monitored daily remotely by Case Managers (nurses trained in Bora Care solution), who, when the BVS3 \> 3 alert is triggered on Bora Connect, call the patient to inform the patient about his symptoms, then alert the pulmonologist by transmitting the information from Bora Connect and the minutes of the phone call, who, according to conventional management, decides whether or not to hospitalize the patient, or to generate an unscheduled consultation in order to prescribe drug treatment, and/or to prescribe additional examinations, and/or to adapt the patient's oxygen therapy prescription.

The Case Manager re-evaluates the situation after 48 hours and 96 hours if necessary and forwards the information to the pulmonologist. The nature of the transmission of information (telephone or email) between the Case Manager and the pulmonologist in case of an alert is defined when the patient is included by the pulmonologist. If desired, remotely monitored patients will be able to access the Bora Connect interface provided for patients (restricted viewing of data).

Interventions

  • Device Boracare remote monitoring solution
    Bora Band wristband measuring vital signs at home, Bora Connect platform for caregiver visualization and BVS3 early detection of COPD exacerbations

Primary outcome measures

  • Demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations compared to conventional follow-up. [Time frame: 1 year]
Secondary outcome measures (12)
  • Evaluate the effect of the device on the number of hospitalizations per patient. [Time frame: 1 year]
  • Evaluate the effect of the device on the average length of stay. [Time frame: 1 year]
  • Assess the overall quality of life of patients at baseline and at the end of the trial. (1) [Time frame: 1 year]
  • Assess the overall quality of life of patients at baseline and at the end of the trial. (2) [Time frame: 1 year]
  • Assess the overall quality of life of patients at baseline and at the end of the trial. (3) [Time frame: 1 year]
  • Assess the conformity of use of the Bora Care device. [Time frame: 3 years]
  • Assess the impact of the device on the organisation of care. (1) [Time frame: 3 years]
  • Assess the impact of the device on the organisation of care. (2) [Time frame: 3 years]
  • Assess the impact of the device on the organisation of care. (3) [Time frame: 3 years]
  • Assess the impact of the device on the quality of support. (1) [Time frame: 3 years]
  • Assess the impact of the device on the quality of support. (3) [Time frame: 3 years]
  • Assess patient and caregiver satisfaction with the device. (1) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Patient over 18 years of age with COPD defined according to the recommendations of the SPLF, whose level of respiratory function in a stable state is known (measured less than 12 months), recruited in pulmonology
  • Patient who has been hospitalized for COPD exacerbation in the previous 12 months
  • Informed patient who has signed consent,
  • Patient enrolled in a social security scheme (Art L1121-11 of the CSP)

Exclusion criteria

  • Presence of a comorbidity considered unstable or very severe by the investigator.
  • Patient with psychological frailties,
  • Patient already included in another interventional trial,
  • Patient who does not speak French and is unable to use the Bora Band tool and without access to a caregiver,
  • Patient protected under guardianship or unable to give free and informed consent.
  • Pregnant or nursing woman

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 10 centers
  • CHU de Brest — Brest
  • Centre Hospitalier Bretagne Atlantique — Vannes
  • Centre Hospitalier de Chartres — Le Coudray
  • Centre Hospitalier Verdun — Verdun
  • Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) — Lille
  • Clinique du Millénaire — Montpellier
  • Centre Hospitalier Universitaire de Toulouse — Toulouse
  • Hôpital Européen Marseille — Marseille
  • … and 2 more centers

Identifiers

NCT: NCT06523140 · 2023-A02454-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗