Detection of respiratory exacerbations in adults with cystic fibrosis using artificial intelligence
| ISRCTN | ISRCTN27664426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27664426 |
| IRAS number | 316930 |
| Secondary identifying numbers | CPMS 55288, AI_AWARD02259, IRAS 316930 |
- Submission date
- 04/07/2023
- Registration date
- 18/07/2023
- Last edited
- 17/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Cystic Fibrosis (CF) is a life limiting, inherited condition that causes a build up of thick, sticky mucus in the lungs and other organs that leads to severe and persistent bacterial infections. CF is characterised by periods of relative stability punctuated abrupt clinical deterioration known as acute pulmonary exacerbations (APEs.) APEs drive pulmonary inflammation, progressive lung damage and premature death. In preliminary studies we have shown that home monitoring empowers patients and can safely reduce routine outpatient hospital attendance by 50%.
Breathe RM Signal is a smartphone app. It uses Bluetooth data from participants monitoring themselves at home with devices such a spirometer, heart rate monitor and weighing scales to see if they are stable or at risk of having an APE. After using their home monitoring equipment participants are able to see an easy-to-understand colour on the app with instructions of what they need to do. The app helps to detect the onset of an APE earlier than symptoms appear, which enables the infection to be treated earlier. This may reduce how much treatment is needed and how long it is needed for. Participants will also be asked to complete quality of life questionnaires during the study. The purpose of this study is to establish if Breathe RM Signal (developed from previous studies where participants monitored physiological parameters at home) improves quality of life, reliably predicts the onset of APEs and is safe to use in clinical practice.
Who can participate?
Adults over 18 years with CF and suitable for home monitoring.
What does the study involve?
All participants will be given an activity monitor, weighing scales, oxygen saturation monitor and spirometer (to measure lung function) to use at home. These devices connect to an app called Breathe RM via Bluetooth. They help to predict if a participant is at risk of an acute pulmonary exacerbation (APE). The results from these devices can then be seen by the participant and by their clinical team (if the participant agrees to this). Participants will be randomly allocated to be in one of two groups. There will be 200 participants in each group.
• Group 1. will see their data from home monitoring as usual (Breathe RM).
• Group 2. will see their data from home monitoring (Breathe RM) plus the Breathe RM Signal feature. Depending on the home monitoring data received the Breathe RM Signal predictor will show the use a colour. –
o green, no sign of impending APE
o amber, health may be deteriorating. Optimise treatments and contact your clinical team if needed.
o red, signs that health is deteriorating and at risk of APE. Contact your CF team within the next 48 hours for review.
o white, not enough data has been entered into the system to provide a safe prediction. Please increase the amount of home monitoring you do.
Participants are advised that Breathe RM Signal is a guide and that if at any point they feel unwell they should contact their clinical team in the usual way.
Participants in both groups will be asked to complete a user acceptability questionnaire 3 monthly and a health-related quality of life questionnaire at the start of the study and then 3 monthly. Each questionnaire can be completed on paper or electronically and they take around 15 minutes to complete. Participants will be asked if they would like to participate in virtual (or one to one) discussions to give feedback regarding how they found using Breathe RM and/or Breathe RM Signal. People with CF have been involved in every stage of the design process and will continue to be involved throughout the study and dissemination of results.
A group of people with CF are involved in testing the user interface for the Breathe RM Signal App and ensuring that it is easy to use and understand.
What are the possible benefits and risks of participating?
Participants may feel empowered to take control of their health through home monitoring. If the Breathe RM Signal predictor detects an impending APE before symptoms start participants would benefit from earlier treatment options and therefore less long-term lung damage. Quality of life may be improved.
No risks.
Where is the study run from?
Papworth Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
October 2021 to April 2026
Who is funding the study?
1. National Institute for Health and Care Research (NIHR) (UK)
2. LifeArc (UK)
Who is the main contact?
Prof Andres Floto, arf27@cam.ac.uk
Lucy Gale, lucy.gale1@nhs.net
Contact information
Scientific
University of Cambridge
Heart and Lung Research Institute
Cambridge Biomedical Campus
Papworth Road
Cambridge
CB2 0BB
United Kingdom
 ORCID ID |
0000-0002-2188-5659 |
|---|---|
| Phone | +44 1223 638000 |
| arf27@cam.ac.uk |
Public
Royal Papworth Hospital
Papworth Road
Cambridge
CB2 0AY
United Kingdom
| ORCID ID |
0000-0002-5697-810X |
|---|---|
| Phone | +44 1223 638480 |
| lucy.gale1@nhs.net |
Study information
| Study design | Randomised; Both; Design type: Process of Care, Device, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Artificial intelligence to control acute pulmonary exacerbations in cystic fibrosis |
| Study acronym | ACE-CF |
| Study hypothesis | Visibility of Breathe RM Signal alongside home monitoring data will improve HRQOL (health related quality of life) and health parameters compared to visibility of home monitoring data alone. |
| Ethics approval(s) |
Approved 13/03/2023, East of England - Cambridge Central Research Ethics Committee (Equinox House City Link, Nottingham, NG2 4LA, United Kingdom; +44 207 104 8089; cambridgecentral.rec@hra.nhs.uk), ref: 23/EE/0031 |
| Condition | Cystic fibrosis |
| Intervention | This is a one year randomised controlled trial. There will be 400 adult participants from 6 CF specialist centres across the UK. Potential participants will be approached regarding the study by the research team during their routine clinic appointments or inpatient stays. Potential participants may also be contacted by telephone, text, email or letter by the study team. All participants will be given an activity monitor, weighing scales, oxygen saturation monitor and spirometer (to measure lung function) to use at home. These devices connect to an app called Breathe RM via Bluetooth. They help to predict if a participant is at risk of an acute pulmonary exacerbation (APE). The results from these devices can then be seen by the participant and by their clinical team (if the participant agrees to this). Participants will be randomly allocated to be in one of two groups. There will be 200 participants in each group. Group 1. will see their data from home monitoring as usual (Breathe RM). Group 2. will see their data from home monitoring (Breathe RM) plus the Breathe RM Signal predictor. Depending on the home monitoring data received the Breathe RM Signal predictor will show the user a colour. - green, no sign of impending APE - amber, health may be deteriorating. Optimise treatments and contact your clinical team if needed. - red, signs that health is deteriorating and at risk of APE. Contact your CF team within the next 48 hours for review. - white, not enough data has been entered into the system to provide a safe prediction. Please increase the amount of home monitoring you do. Participants are advised that Breathe RM Signal is a guide and that if at any point they feel unwell they should contact their clinical team in the usual way. Participants in both groups will be asked to complete a user acceptability questionnaire 3 monthly and a health-related quality of life questionnaire at the start of the study and then 3 monthly. Each questionnaire can be completed on paper or electronically and they take around 15 minutes to complete. Participants will be asked if they would like to participate in virtual (or one to one) discussions to give feedback regarding how they found using Breathe RM and/or Breathe RM Signal. People with CF have been involved in every stage of the design process and will continue to be involved throughout the study and dissemination of results. A group of people with CF are involved in testing the user interface for the Breathe RM Signal App and ensuring that it is easy to use and understand. |
| Intervention type | Other |
| Primary outcome measure | Quality of life using Cystic Fibrosis Revised Questionnaire (CFQR) at baseline and 12 months |
| Secondary outcome measures | 1. Lung function (FEV1 % predicted) at baseline and 12 months 2. Number of days requiring antibiotics for acute pulmonary exacerbation at baseline and 12 months |
| Overall study start date | 01/10/2021 |
| Overall study end date | 14/04/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 400; UK Sample Size: 400 |
| Participant inclusion criteria | 1. Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels 2. Age > = 18 years of age 3. Able to provide written informed consent 4. Patients who are known to be suitable for home monitoring and able to manage the process or those currently undertaking home monitoring |
| Participant exclusion criteria | 1. Patients unable to provide written informed consent 2. Patients unwilling to consent to their link anonymized data from home monitoring being used for research 3. Patients unable to perform regular home monitoring 4. Lung transplant recipients 5. Patients participating in an interventional medicinal research study within the preceding 3 months |
| Recruitment start date | 12/07/2023 |
| Recruitment end date | 28/02/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Cambridge Biomedical Campus
Cambridge
CB2 0AY
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Denmark Hill
London
SE5 9RS
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Southampton
SO16 6YD
United Kingdom
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Hospital/treatment centre
Papworth Road
Cambridge Biomedical Campus
Cambridge
CB2 0AY
England
United Kingdom
| Phone | +44 1223 638000 |
|---|---|
| victoria.hughes1@nhs.net | |
| Website | http://www.papworthhospital.nhs.uk/ |
"ROR" |
https://ror.org/01qbebb31 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 30/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
17/02/2025: Leeds Teaching Hospitals NHS Trust and Nottingham University Hospitals NHS Trust - City Campus were added to the study participating centres.
20/11/2024: The following changes were made:
1. The overall study end date was changed from 30/09/2024 to 14/04/2026.
2. The recruitment end date was changed from 31/03/2024 to 28/02/2025.
3. The study participating centres University Hospital Southampton and the University Hospital of South Manchester NHS Foundation Trust were added.
20/09/2023: A link to the HRA research summary was added.
04/07/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
