Active not recruitingOBSERVATIONAL

Analysis of Remote Monitoring/Virtual Clinic Data in Adult Patients With Cystic Fibrosis (Project Breathe)

This study, called 'Project Breathe', is for adults with Cystic Fibrosis (CF) and aims to understand how home monitoring helps manage their condition. Researchers want to know how people find using home monitoring equipment and if it can help detect chest infections earlier than usual care. Participants will use devices such as a handheld lung function tester, weighing scales, a blood oxygen monitor, and an activity tracker. This information is sent to a smartphone app that both the participant and their doctors can see. The study also aims to figure out if home monitoring can save money or if there are extra costs involved, compared to standard care. Around 610 adults from four different UK CF centres will take part.

At a glance

Status

Active not recruiting

Sponsor

Papworth Hospital NHS Foundation Trust

Enrolment target

475

Start

20 Feb 2019

Estimated completion

31 Dec 2030

Cystic Fibrosis

What is this study about?

Imagine being able to keep a closer eye on your health from the comfort of your own home, especially if you have a condition like Cystic Fibrosis (CF). That's exactly what 'Project Breathe' is all about. This study is exploring how home monitoring, using special devices, can help adults with CF. The main idea is to see if regularly checking your health at home can help spot problems like chest infections sooner.

Participants in the study will be given several easy-to-use devices for home monitoring. These include a small machine to check your lung function, a set of weighing scales, a device to measure oxygen levels in your blood, and a monitor for your activity and heart rate. All the information collected from these devices will go to a special app on a smartphone. Both you and your healthcare team will be able to see this information, which could help your doctors understand how you're doing between your clinic visits.

This study is 'observational', meaning researchers are watching and learning from people's experiences with home monitoring, rather than introducing new treatments. It won't change your usual medical care. They also want to understand how people feel about using this technology and to see if using it can give an early warning sign when someone might be getting sick. The study will also look at the financial side, comparing the costs of home monitoring to traditional care. This information will help doctors and healthcare providers decide the best ways to support people with CF in the future.

Key takeaways

Learn about home monitoring for adults with Cystic Fibrosis.
Use easy-to-manage devices at home to track your health.
Information goes to a smartphone app for you and your doctors.
Aims to detect chest infections sooner than usual care.
Your regular medical treatment will not be affected.
Data is kept private and secure.

Who may be eligible?

This study is looking for adults who have been diagnosed with Cystic Fibrosis. You need to be at least 18 years old and able to understand and agree to take part in the study in writing. Importantly, you should already be suitable for home monitoring or currently using it, and feel comfortable managing these devices and recording your information.

There are also some reasons why you might not be able to join. For example, if you're unable to give your written consent, or if you don't want your private health data from home monitoring to be used for research. Also, if you have had a lung transplant, this study might not be suitable for you.

Quick self-check

Do I have a confirmed diagnosis of Cystic Fibrosis?
Am I 18 years old or older?
Am I comfortable giving written agreement to join the study?
Am I suitable for and currently managing home monitoring, or willing to learn?
Have I not had a lung transplant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in 'Project Breathe', you won't need to visit the hospital more often than usual. This study is designed not to interfere with your regular medical appointments or care. The main part of your involvement will be at home, where you will regularly use the provided monitoring equipment several times a week. This equipment includes a small device to check your lung function, weighing scales, a monitor for your blood oxygen, and a device to track your activity and heart rate. The information from these devices will automatically link to a smartphone app that both you and your care team can see. You'll also be asked to fill out an online questionnaire, which should take about 15 minutes, or you can complete a paper version if you prefer. The total duration of your participation in the study is not specified, but it's an ongoing observational study.

Potential risks and benefits

Participating in this study involves using simple monitoring devices at home, which should pose very few risks. The main commitment is your time to use the equipment and complete a questionnaire. A potential benefit is gaining a better understanding of how home monitoring can help manage Cystic Fibrosis, potentially allowing for earlier detection of chest infections. You are entirely free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Royal Papworth Hospital
Cambridge, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom

Common questions

What is the main purpose of this study?

The study wants to see how home monitoring helps adults with Cystic Fibrosis and if it can spot chest infections earlier.

What equipment will I use at home?

You'll use a lung function tester, weighing scales, a blood oxygen monitor, and an activity/heart rate tracker. All connect to a smartphone app.

Will my regular medical care change if I join?

No, this study will not affect your standard care or appointments; it runs alongside your usual treatment.

Is my personal health information kept private?

Yes, all your data will be 'link-anonymised', meaning your personal details are separated from your health information and kept secure.

Can I stop participating if I change my mind?

Absolutely, you can withdraw from the study at any time, and it won't affect your medical care.