The CF-Tracker Study
This is a study to help us understand what causes “exacerbations” in people with CF.
Exacerbations are when people with CF experience more chest symptoms, like cough, breathlessness and wheezing. They might also have fevers, feel more tired, and sometimes have other symptoms such as weight loss, chest pain, or sinus congestion.
Many people with CF experience more than one exacerbation per year, which can cause a lot of disruption to their work and family life.
Each year, around 1 in 4 people with CF end up needing intravenous antibiotics (i.e. given through a vein, usually in hospital) because of an exacerbation. Unfortunately, around 1 in 3 people with CF do not fully recover their lung function after an exacerbation.
If we can understand what causes exacerbations, and what makes someone with CF more at risk of an exacerbation, we can plan how to prevent them. This is something that people with CF have highlighted as needing to be a priority to improve their care and wellbeing.
What do we need to know to better understand the causes of exacerbations?
There are a lot of different factors to consider when it comes to exacerbations. In this study, we’ll be exploring:
Why some people experience more exacerbations than others
The impact of viruses on people with CF and which viruses cause the most symptoms
Ways of picking up lung infections that might be better or easier to measure than sputum
What happens when an exacerbation starts and what factors lead to recovery
The role does air pollution, including whether it make exacerbations more likely
What does the study involve?
The Tracker study has been designed to be easy for people to do, without placing too many demands on their time. That is why it involves only a single clinic visit and then posting in samples from home. In some centres we are also running a version of the Tracker study with three clinic visits, but the study is otherwise the same, and the clinic visits are the same each time.
At the clinic visit we will collect samples of sputum and blood, as well as saliva, nasal swab and nasal liquid, and a sweat test. We will get you to carry out lung function tests and collect information about your CF.
You will then be given a supply of home sampling kits. We will ask you to complete one of these every 2 weeks for 6 months (a total of 13 times). Home sampling includes:
A nasal and throat swab (provided in the kit), which you will do on yourself and post back to us
A saliva sample
A short questionnaire about your symptoms
Lung function (blowing tests) using your own home spirometer.
If you are unwell, or starting antibiotics for an exacerbation, we will ask you to send back an EXTRA kit, consisting of the same samples (swab and saliva), same questionnaire, and an extra spirometry. In these kits, there is also equipment to perform a finger prick blood sample.
For those at Group B centres (Manchester, Leeds, Newcastle, Cardiff) there are some additional sleep monitoring assessments offered that are described within the information sheet.
1. Clinic Visit
At a research visit in clinic, we will collect a:
Sputum sample
Blood sample
Finger-prick blood sample
Saliva sample
Nasal swab and nasal liquid
Sweat test
Urine sample
And we will get you to complete
Spirometry
Questionnaires
We will also collect information on your CF from your records
2. Home Sampling
You will complete and post back a home sampling kit every two weeks for six months (13 in total).
This includes a
Nasal and throat swab
Saliva sample
Finger-prick blood sample (just the first two times)
These are posted back in a pre-paid box
And also involves
Home spirometry
A short questionnaire
The optional study app will help remind you when to do this
3. If you are unwell
If you are unwell, you will complete an EXTRA home assessment
This includes a
Nasal and throat swab
Saliva sample
A finger-prick blood sample
These are posted back in a pre-paid box
And also involves
Home spirometry
A short questionnaire, with a few extra questions about your new symptoms
If you want more details about the study you can download the Participant Information Sheets from the link below.
There are different Information Sheets for Manchester, Leeds, Liverpool, Cardiff and Newcastle participants as these sites offer more detailed assessments at the in-clinic visits; the home monitoring is the same at all sites though.
Frequently Asked Questions
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At the clinic visit we will carry out a number of tests to understand what is happening in your lungs and your body as a result of CF, and to help us identify what changes during an exacerbation. To do this we would like to carry out the following tests, which are described in more detail in the Patient Information Sheet→.
Blood tests
Finger prick blood test (like having a blood glucose measurement)
Sputum sample. If you struggle with this we can help you by getting you to breathe in a salt-water spray called “hypertonic saline sputum induction”. It will help loosen sputum in the airways so that it can be coughed up.
Blowing tests (spirometry)
Sweat chloride
Throat and nasal swabs
Saliva samples
Questionnaires
For those at Group B centres (Manchester, Leeds, Newcastle, Cardiff) there are some additional lung function, breathing tests that are described in the Patient Information Sheet
Apart from this, the study is all done from home!
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Everyone taking part will have the option of using the CF-Tracker study app. This can be downloaded from Apple→ or Android→ stores. The app will:
have all the study information, so you can access it easily
show you a diary of reminders and notifications for when samples need to be posted
provide a link to the questionnaire for that week.
If you prefer not to use the app, we can provide paper questionnaires or we can email the link every fortnight. We can also send text reminders if this is easier for you.
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There is no direct benefit to you personally. However, the information we learn may help in caring for other patients in the future.
Importantly, you will not be disadvantaged in any way. We will act on any test results that require follow-up so that you receive the care you need. Most commonly this will be informing you, your CF care team, or your GP of a particular test result. Otherwise, you and your CF team will not receive the outcome of any test or assessment. The exception to this is your lung function (spirometry) test. As you will be using your own device, supplied by your CF clinic, this information will be visible to those in the CF clinic.
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Being a part of this study means that more blood or sputum samples will be taken than are needed for normal care. Whenever possible these samples will be taken at the same time as your routine samples to reduce the extra procedures. There is a risk of pain or discomfort when samples are taken, and these are detailed in the ‘tests and procedures’ section of this information sheet.
If you take part in the study and we collect data from your records, there is minimal risk to you. All information will be used anonymously so no one will know that this information relates to you.
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Absolutely! If you are already enrolled in another research study, this will not affect your ability to take part in this study. Similarly, if you wish to take part in another research study you can stay in this one too. We may ask your permission to link your information from other studies to the information collected for this study so that we can build a bigger picture around the causes of exacerbations.
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You will not receive any payment or reimbursement for participating in this study. If you have any research specific visits to the research team / your local centre, then car parking reimbursement or other reimbursement for travel can be provided. We also cover the cost of posting back each of the home sample kits back to us (these are pre-paid).
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Yes, if you sign up and then change your mind, you are free to withdraw from the study at any time and without giving a reason. This will not affect your care in any way and all that we ask is that you complete a withdrawal form. This is so we are clear as to whether we can continue to access your electronic healthcare records. We would like to continue to access your records for up to 15 years to understand how your CF changes over time. If you do not want this to happen, you can tell us on the withdrawal form.
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If you do decide to withdraw then any information and samples already collected will remain and be used in the study. These will all be anonymised. No further samples or data collection will be performed and we will not contact you again about this study.
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In order to participate in this research project we will need to collect information that could identify you, called “personal identifiable information”. Specifically we will need to collect name, address, contact details, date of birth, ethnicity, details about your CF, details about the treatment you receive, record of consent, blood and sputum samples.
You have a number of rights under data protection law regarding your personal information. For example you can request a copy of the information we hold about you. Sometimes your rights would be limited if it would prevent or delay the research. If this happens, you will be informed by the research team.
If you would like to know more about your different rights or the way we use your personal information to ensure we follow the law, please consult our Privacy Notice for Research, available at https://documents.manchester.ac.uk/display.aspx?DocID=37095→.
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This is a research study organised by the NIHR Manchester Biomedical Research Centre→ and sponsored by the University of Manchester. The study is being funded by the Cystic Fibrosis Trust→ and LifeArc→, as part of a CF Innovation Hub award to the University of Manchester. None of the doctors will be paid themselves for including you in the study.