Management of COPD Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Boracare remote monitoring solution.
- Кому может быть актуально
- Состояния в реестре: COPD. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Management of Chronic Obstructive Pulmonary Disease (COPD) Patients With BoraCare® Remote Monitoring Solution Including BVS3 Early Detection Score for COPD Exacerbations
Обзор
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.
Подробное описание
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).
Вмешательства
- Устройство 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
Первичные конечные точки
- Demonstrate the superiority of remote monitoring with the Bora Care solution in patients with COPD and frequent exacerbations compared to conventional follow-up. [Срок оценки: 1 year]
Вторичные конечные точки (12)
- Evaluate the effect of the device on the number of hospitalizations per patient. [Срок оценки: 1 year]
- Evaluate the effect of the device on the average length of stay. [Срок оценки: 1 year]
- Assess the overall quality of life of patients at baseline and at the end of the trial. (1) [Срок оценки: 1 year]
- Assess the overall quality of life of patients at baseline and at the end of the trial. (2) [Срок оценки: 1 year]
- Assess the overall quality of life of patients at baseline and at the end of the trial. (3) [Срок оценки: 1 year]
- Assess the conformity of use of the Bora Care device. [Срок оценки: 3 years]
- Assess the impact of the device on the organisation of care. (1) [Срок оценки: 3 years]
- Assess the impact of the device on the organisation of care. (2) [Срок оценки: 3 years]
- Assess the impact of the device on the organisation of care. (3) [Срок оценки: 3 years]
- Assess the impact of the device on the quality of support. (1) [Срок оценки: 3 years]
- Assess the impact of the device on the quality of support. (3) [Срок оценки: 3 years]
- Assess patient and caregiver satisfaction with the device. (1) [Срок оценки: 1 year]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Франция · 10 центров
- 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
- … и ещё 2 центра
Идентификаторы
NCT: NCT06523140 · 2023-A02454-41