What is Awake Prone?

Awake Prone is a research study. We are inviting people to take part who are in hospital and who are currently receiving a moderate or high amount of oxygen. The study is aiming to find out if lying on your front (awake prone positioning) or standard care (sitting up in bed) reduces the chance that someone will go on a ventilator. If you take part, which of these two groups you are in will be decided by chance.

Individuals in the awake prone positioning group will lie on their tummy for at least 8 hours a day for up to five days.

Doctors and other healthcare professional know that lying on your tummy is helpful if you have COVID-19, but do not currently know if awake prone positioning is helpful when you need oxygen for other conditions.

What will I need to do if I take part?

If you agree to take part, we will ask you to provide consent and you will be assigned by chance to one of two groups: awake prone positioning or standard care. You, the research team, or the medical care team will not be able to choose which group you are in. This will be decided by a computer at random, just like tossing a coin or drawing lots. This type of study is called a randomised controlled study and provides the best way for researchers and healthcare professionals to know if a treatment works.

What is the standard care group?

If you are in the standard care group, you will continue to receive standard NHS care. This means that you will normally sit upright in bed. You will receive all other appropriate treatments for your respiratory failure, such as antibiotics or other ways of giving you oxygen.

What is the awake prone positioning group?

If you are in the awake prone positioning group, the healthcare professionals looking after you will help you to move so that you are lying on your tummy. We ask that you lie on your tummy for at least 8 hours each day for a maximum of five days. You may be able to stop sooner if you recover more quickly. You may choose to lie on your tummy for a continuous period of 8 hours or to split this up into smaller periods of time. If you find lying on your tummy uncomfortable, the healthcare professionals looking after you will help you find ways to make it more comfortable. For the rest of the time, you may choose your position. You will receive all other appropriate treatments for your respiratory failure, such as antibiotics or other ways of giving you oxygen.

Will you collect information about me?

We will collect information about everyone in both groups to see how well and how quickly they recover. We will also record whether you need to go on a ventilator. The information that we collect will include your age, sex, ethnicity and your medical information. We describe how we will use your data in our second information leaflet.

After leaving hospital, we will also ask you to complete a questionnaire about your recovery at 2 and 6 month timepoints. They will each take you 5-10 minutes to complete. If needed, someone can complete them on your behalf. We will share your name, email address, and phone number with a third-party company in order to send you the questionnaires by text message or email. We will also get in touch by text message or email if we have any queries about your questionnaire or if we have any updates related to the study.

Are there are studies available?

The University of Warwick is currently leading several studies looking at how we treat patients with respiratory failure. This group of studies is called the ‘Confederation of Respiratory Critical Care Trials’ or ‘CoReCCT’. Awake Prone is one of these studies. If you do need to go on a ventilator, we may approach you or your family about other studies within the CoReCCT family that you might be able to take part in. You do not have to take part in any of these other studies.

Will my taking part in the study be kept confidential?

The University of Warwick is the study Sponsor and data controller. They will use information about you to undertake this study. This means that they are responsible for looking after your information and using it properly. Please read the data information leaflet, which explains how we will use and keep data safe and what you can do if something goes wrong.

Who is organising and funding the research?

This study is being sponsored and carried out by the University of Warwick, in partnership with NHS hospitals across the United Kingdom. The study is being coordinated by Warwick Clinical Trials Unit. The study is funded by the National Institute for Health Research, Health Technology Assessment (NIHR154796).

Enquiries:

If you have any questions, please contact the study team via email.

Email: awakeprone@warwick.ac.uk

Address:

Awake Prone Study Team
Warwick Clinical Trials Unit,
Warwick Medical School,
University of Warwick,
Coventry.
CV4 7AL