Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)

Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis

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.)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Alexis TOULLEC; Phone Number: +33 02 21 65 70 01; Email: clinical@biosency.com

Study Locations

• France
  • Rennes, France, 35000
    • Recruiting
    • Chru Pontchaillou
    • Contact: Stéphane Jouneau, MD; Phone Number: +33 0299282478

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify relevant metrics in the signals collected by the Bora Care® solution for early detection of medical events.	Evolution of vital signs in patients on days prior to the date of other medical events during follow-up.	1 year
Assess compliance with the use of the Bora Care® bracelet by patients.	Number of hours of wearing the Bora Band® bracelet normalised by the total number of hours of the remote monitoring session, information collected via the Bora Care® too.	1 year
Assess patient satisfaction and reassurance provided by the remote monitoring solution	Subjective assessment by the patient of the device of the reassurance provided by the device, of the help to resume physical activity provided by the device, obtained using satisfaction questionnaires at M6 and M12. SF36 Quality of Life Questionnaire score collected at D0, M6 and M12.	1 year
Assess the satisfaction and adherence of healthcare professionals to the remote monitoring solution.	Subjective assessment of health care professionals' satisfaction with and adherence to the Bora Care® remote monitoring solution, including an organizational impact assessment and an assessment of clinical relevance using a questionnaire at the end of the study.	1 year
Assess side effects related to the Bora Care® device.	Number and nature of Bora Care® adverse events	1 year

Collaborators and Investigators

• Sponsor: Biosency
• Collaborators: Rennes University Hospital; Air de Bretagne; Association Fibroses Pulmonaires France
• Investigators: Principal Investigator: Stéphane JOUNEAU, MD, CHRU PONTCHAILLOU Rennes

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Exacerbation; Idiopathic pulmonary fibrosis; Remote monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 2023-A02063-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not applicable. Data are not intended to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No