Idiopathic Pulmonary FibrosisREACTNCT06445686
Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.
An observational study of Idiopathic Pulmonary Fibrosis, run by Biosency at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2024to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chru Pontchaillou
Rennes, 35000
Stéphane Jouneau, MD, 0299282478 ext. +33
About this study
Official title: 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.
Read the 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
- Keywords
- Idiopathic pulmonary fibrosis, Remote monitoring, Exacerbation, Prevention
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Assess side effects related to the Bora Care® device.
Number and nature of Bora Care® adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start17 Jun 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosency
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rennes University Hospital, Air de Bretagne, Association Fibroses Pulmonaires France
- Responsible party
- Sponsor
- Investigators
- Stéphane JOUNEAU, MD, Principal investigator, CHRU PONTCHAILLOU Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445686
- Sponsor's protocol ID
- 2023-A02063-42
- Acronym
- REACT
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. Data are not intended to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)
- ClinicalTrials.gov ID
- NCT06445686
- Acronym / sponsor ID
- REACT / 2023-A02063-42
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic pulmonary fibrosis, Remote monitoring, Exacerbation, Prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BiosencyIndustry (pharma, biotech, devices)
- Collaborators
- Rennes University Hospital, Air de Bretagne, Association Fibroses Pulmonaires France
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution.
Time frame: 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.
5 secondary outcomes
Identify relevant metrics in the signals collected by the Bora Care® solution for early detection of medical events.
Time frame: 1 year
Assess compliance with the use of the Bora Care® bracelet by patients.
Time frame: 1 year
Assess patient satisfaction and reassurance provided by the remote monitoring solution
Time frame: 1 year
Assess the satisfaction and adherence of healthcare professionals to the remote monitoring solution.
Time frame: 1 year
Assess side effects related to the Bora Care® device.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: No. Not applicable. Data are not intended to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane JOUNEAU, MD principal investigator
CHRU PONTCHAILLOU Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Biosency at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis TOULLEC (02 21 65 70 01 ext. +33, clinical@biosency.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.