THE UNIFIED-CF Study
This is a study to help us understand how people respond to treatment for exacerbations during illness and recovery.
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.
Each year, around 1 in 4 adults with CF end up needing intravenous antibiotics (i.e. given through a vein, usually in hospital) because of an exacerbation. Many people with CF experience more than one exacerbation per year, which can cause a lot of disruption to work and family life. Unfortunately, around 1 in 3 people with CF do not fully recover their lung function after an exacerbation.
If we can understand how the body responds to infection, how this differs between different people, and how antibiotics affect bugs and the body’s response to bugs, then we can identify why treatments work, and why sometimes they don’t work so well. This is something that people with CF have highlighted as being a priority to improve their care and wellbeing.
What do we need to know to better understand how people respond to treatment for exacerbations?
There are a lot of different factors to consider when it comes to exacerbations. In this study, we’ll be exploring:
· How different bacteria, viruses and signal markers found in the lung affect response to antibiotics.
· Different ways of detecting lung infection and inflammation.
· How the development of antibiotic resistance in bugs affects response to treatment.
· Whether we can predict outcomes to different treatments in advance.
· How exacerbations impact on everyday life for people living with CF.
What does the study involve?
The UNIFIED 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 to provide a sputum sample, some blood, a lung function test in a stable state and complete questionnaires. If you are also taking part in the CF-Tracker study, or have done so previously (within the last year) you can consent to allow us to use the tests we took then, so that you do not need to actually do anything at all for this visit.
After that, nothing will happen in the study unless you are admitted to hospital for treatment of an exacerbation. If you are admitted to hospital, then before you start treatment, we will collect samples including sputum, blood, swabs to look for infection and a breath test. We will also ask you to do questionnaires and a lung function test. You may also be asked to wear an activity tracking wristband to look at your sleep patterns.
As part of the study, you will receive standard exacerbation treatment, and the types of treatment and length of treatment will be chosen by your usual CF team in discussion with you. We will collect samples and symptom questionnaires at various points during your stay in hospital. You will not be asked to stay in hospital any longer than usual by taking part in this study and the decision about when treatment is finished is up to your usual clinical care team and you.
After you have been discharged, we will see you twice more. Firstly, after 2 weeks we will follow you up to get spirometry from you. This could be in clinic or from a home spirometry device if you have one. Then we will see you for a more detailed visit 6-14 weeks after end of treatment. This visit will likely coincide with you attending a routine clinic appointment, so you don’t make a special trip back to hospital. Here we will repeat most samples and assessments. This visit is important and at will give us vital information as to what things have changed vs. remain stable during your recovery from an exacerbation.
Frequently Asked Questions
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At the clinic visits 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.
1. Blood tests
2. 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.
3. Blowing tests (eg spirometry)
4. Breath samples
5. Nasal swab
6. Urine samples
7. Questionnaires
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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.
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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 2 years to understand how many exacerbations you have during the follow-up period. 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 and we will delete any records which link your personal details to the samples. No further samples 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.