Clinical trial NCT06445686: Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.
Official title: Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic pulmonary fibrosis
Remote monitoring
Exacerbation
Prevention
Lead sponsor: Biosency
Sponsor class: INDUSTRY
Collaborators: name: Rennes University Hospital
name: Air de Bretagne
name: Association Fibroses Pulmonaires France
First posted: 2024-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Idiopathic Pulmonary Fibrosis with indication for ambulatory oxygen therapy (Sp02 (peripheral oxygen saturation) ≤ 88% in ambient air during 6-minute walk test)

Brief summary: 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.

Detailed description: 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:

* Inclusion Visit : 6-minute walk test and prescription of oxygen therapy
* Home Installation Visit: installation of oxygen therapy by Air de Bretagne and setup of the Bora Connect® bracelet and Bora Box® Gateway
* Follow-up Visit with the Pulmonologist at 6 months (M6): routine examinations, satisfaction questionnaire, and quality of life questionnaire
* End of Study Visit with the Pulmonologist at 12 months (M12): routine examinations, satisfaction questionnaire, and quality of life questionnaire.

(In case of exacerbation, the follow-up will be extended by 3 months to collect post-exacerbation data.)

Eligibility criteria: 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

Primary outcomes:
measure: Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution.
timeFrame: 1 year
Secondary outcomes:
measure: Identify relevant metrics in the signals collected by the Bora Care® solution for early detection of medical events.
timeFrame: 1 year
measure: Assess compliance with the use of the Bora Care® bracelet by patients.
timeFrame: 1 year
measure: Assess patient satisfaction and reassurance provided by the remote monitoring solution
timeFrame: 1 year
measure: Assess the satisfaction and adherence of healthcare professionals to the remote monitoring solution.
timeFrame: 1 year
measure: Assess side effects related to the Bora Care® device.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: Chru Pontchaillou
Study officials:
affiliation: CHRU PONTCHAILLOU Rennes
name: Stéphane JOUNEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: