What is the purpose of the study?

Delirium is a medical word used to describe a change in brain function which makes a person become suddenly confused. Their behaviour and concentration may also be affected. It can make people feel frightened, restless and suspicious. The symptoms can come on quickly and change from hour to hour. Delirium is usually caused by an illness such as an infection. It is very common, particularly among people with dementia, older people and those in hospital. People who have delirium while they are in hospital often stay longer in hospital.

 

Delirium usually gets better within a few days to weeks but it can sometimes take several months for people to recover fully. Importantly, there is some evidence that delirium may cause permanent damage to the brain. It may make people more likely to develop dementia in the future. For those who already have dementia, delirium may make their dementia get worse. Unfortunately, we do not understand these effects of delirium very well. This is because all of the previous studies were of people whom the researchers had not seen until they developed delirium. The researchers couldn’t be sure whether the people they studied were already showing signs of dementia before they got the delirium.

 

Previous work on this problem has shown that there are ways we can prevent some cases of delirium or make the problem get better faster. It is important to understand the effect of delirium on the brain because it may be a cause of dementia we can reduce or prevent.

 

Why have I been invited?

We have invited you to take part in this study because you are resident in Camden. We aim to offer a representative sample of Camden residents the opportunity to participate, following you up for health problems and hospitalisations over the course of two years.

 

Do I have to take part?

It is up to you to decide to join the study. If you agree to take part, we will describe the study and go through this information sheet. We will then ask you to sign a consent form. You are free to leave the study at any time, without giving a reason. This would not affect the standard of care you receive.

 

What will happen to me if I take part?

We will first arrange a telephone call from one of our team to gather information about you. We will ask you some questions about your health and social circumstances. We will also test your memory. Afterwards, we will see you in the event you are hospitalised at University College or Royal Free Hospitals and we will see you every weekday you are an inpatient.

 

If you are admitted to hospital over the course of the next two years that we are studying, a member of the study team will come to talk to you.

 

This is an observational study which means there are no experiments or trials or new drugs. If you agree to take part in the study, you will be tested for delirium. This is done by asking you some questions particularly about your memory, asking your next of kin some questions and also by observing you. The research team will also write down important information including why you are in hospital, how unwell you are, blood test results, age and gender.

 

During your hospital admission, you will be seen every day during the week. The same assessments will be done on each day. This will continue for the duration of your hospital stay.

 

Two years after your first telephone call, we will contact you again for a repeat telephone interview. You will have the same memory test, which means we can see whether your memory has got worse.

 

Expenses and payments

Taking part in this study will not cost you anything so we will not need to offer expenses. We will not pay you to take part in this research project.

 

What will I have to do?

If you take part in the study, you and your family will have a conversation with a member of the research team lasting up to20 minutes on the ward. This will not affect your medical care at all and can be arranged at a convenient time. We will ask simple questions to testyour memory. If you are not able to answer, this does not matter. We will come to see you regularly while you are on the ward to repeat these assessments.

 

We will contact you again in two years’ time to repeat the telephone interview. These usually take up to40 minutes.

 

What are the possible disadvantages and risks of taking part?

There are no risks of taking part as the study simply involves observing and will not in any way affect your care. The main burden is on your time. We will spend up to20 minutes talking to you when you first come into hospital. We will repeat these assessments daily except at weekends. The telephone assessments (when you first take part and after two years) will take up to 40 minutes.

 

What are the possible benefits of taking part?

The study will not benefit you directly. However, the information we get from this study may help improve the care of people with delirium and dementia.

 

What will happen if I don’t want to carry on with the study?

You are able to leave the study at any time. We would be grateful if you could give us a reason for leaving but you are not obliged to do so. We will need to use the information collected up to your withdrawal.

 

Will my taking part in this study be kept confidential?

Yes. The study is strictly confidential.Any information about you will be stored safely on a dedicated database using a code number to identify you rather than your name.

 

The only people who will have access to this information are those directly involved in the study and people involved in ensuring the high standards of research in the hospital and university.

 

Involvement of the General Practitioner/family doctor (GP)

Your GP will be informed that you are taking part in the study.

 

What will happen to the results of the research study?

We want to publish the results of this study so that other people can learn from us. We may also present our results at national and international conferences. You will not be identified.We will write to you to let you know the results of the study once they are available.

 

Who is organising and funding the research?

The study is being funded by the Wellcome Trust.

 

Who has reviewed the study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by the London Camden and King’s Cross National Research Ethics Committee.

 

Further information and contact details

For more information about research, you may find the following website useful:

 

http://www.nhs.uk/Conditions/Clinical-trials/Pages/Introduction.aspx

 

What if there is a problem?

Any complaint about the way you have been dealt with during the study will be addressed. To report a problem, or for specific information about this research project, please contact the project lead:

 

Dr Daniel Davis (in charge of the study)

MRC Unit for Lifelong Health and Ageing at UCL

33 Bedford Place

London, WC1B 5JU

Tel: 020 7670 5707

Email: linkage-camden@ucl.ac.uk

 

Please also contact Dr Davis if you would like advice as to whether you should participate or if you are unhappy with the study.

 

For more information, you may find the following websites helpful:

 

http://www.nhs.uk/Conditions/dementia-guide/Pages/about-dementia.aspx

http://www.alzheimers.org.uk/site/scripts/documents.php?categoryID=200120

http://www.nhs.uk/ipgmedia/national/Royal%20College%20of%20Psychiatrists/Assets/Delirium.pdf

 

For independent advice regarding participating in research studies you can contact the Patient Advice and Liaison Service (PALS).

[PALS contact details for Camden CCG, UCH and RFH]

 

 

Long-term Information and Knowledge for Ageing - Camden