RECRUITINGOBSERVATIONAL
Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.
Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Locations (1)
Chru Pontchaillou
Rennes, France