Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Biosency
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution.
研究概览
简要总结
The aim of this study is to assess the feasibility of early detection of acute exacerbations of idiopathic pulmonary fibrosis by the remote monitoring of vital signs.
The main question the study aims to answer is: Could a remote monitoring device allow for earlier detection of exacerbations with individualized monitoring and continuous data collection? All patients will receive conventional clinical follow-up based on their health status and clinical recommendations. At the same time, they will benefit from the Bora Care® medical remote monitoring device.
详细描述
All patients will receive conventional clinical follow-up based on their health status and clinical recommendations. At the same time, they will benefit from the Bora Care® medical remote monitoring device.
To do this, they will be equipped with a Bora Band® connected wristband that measures vital signs at home, and the Bora Box® Gateway that ensures connectivity and allows automatic data uploading in real time to the Bora Connect® data visualization platform.
The home healthcare provider Air de Bretagne will be involved in the study to support each patient in the use of the connected wristband.
At the end of the follow-up period, the collected data will be retrospectively analysed to identify the most relevant metrics within the time series of vital signs for early detection of Idiopathic Pulmonary Fibrosis exacerbations, and to assess the feasibility of early detection of Idiopathic Pulmonary Fibrosis exacerbations using a score that could trigger an alert prior to the date the patient reports clinical signs or the date the pulmonologist is consulted for exacerbation of Idiopathic Pulmonary Fibrosis.
Procedure:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age, ideally 50% male and 50% female
- •Patient with IPF with a known level of respiratory function (EFR and blood gas less than 3 months)
- •Stable patient, i.e. without hospitalisation or exacerbation in the last 3 months
- •Patient desaturating at 6MW in ambient air (AA) and requiring ambulatory oxygen therapy (SpO2 AA ⩽ 88%)
- •Patient not receiving walking or permanent oxygen therapy at baseline
- •Informed patient who has signed consent
- •Patient affiliated to a social security scheme
- •Patient not monitored by a home healthcare provider other than Air de Bretagne.
排除标准
- •Vulnerable patient
- •Patient receiving ambulatory or permanent oxygen therapy at baseline
- •Patient already seen with another healthcare provider (e.g. OSAS)
- •Patient unable to use the Bora Band® tool and without access to a caregiver
- •Presence of co-morbidity considered unstable or very severe by the investigator
- •Patient protected, under guardianship or incapable of giving free and informed consent
结局指标
主要结局
Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution.
时间窗: 1 year
Correlation between changes in time series of vital signs (heart rate, respiratory rate) in patients in the days prior to diagnosis of exacerbation of Idiopathic Pulmonary Fibrosis and onset of exacerbation of Idiopathic Pulmonary Fibrosis.
次要结局
- Assess compliance with the use of the Bora Care® bracelet by patients.(1 year)
- Assess patient satisfaction and reassurance provided by the remote monitoring solution(1 year)
- Assess side effects related to the Bora Care® device.(1 year)
- Identify relevant metrics in the signals collected by the Bora Care® solution for early detection of medical events.(1 year)
- Assess the satisfaction and adherence of healthcare professionals to the remote monitoring solution.(1 year)