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

NCT ID: NCT06445686

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2026-02-28

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.)

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: collaborator

Air de Bretagne

UNKNOWN

Sponsor Role: collaborator

Association Fibroses Pulmonaires France

UNKNOWN

Sponsor Role: collaborator

Biosency

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane JOUNEAU, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU PONTCHAILLOU Rennes

Locations

Chru Pontchaillou

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alexis TOULLEC

Role: CONTACT

clinical@biosency.com

02 21 65 70 01 ext. +33

Facility Contacts

Stéphane Jouneau, MD

Role: primary

0299282478 ext. +33

Other Identifiers

2023-A02063-42

Identifier Type: -

Identifier Source: org_study_id