1 - What is the study title
Models of care for diabetes in the community (MODCOM)
2 - Invitation
You are being invited to take part in a research study led by the University of Leicester. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Talk to others about the study if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
3 - What is the purpose of the study?
There is now very good evidence that controlling blood sugar and other risk factors such as blood pressure improves the quality of life for people with diabetes as well as reducing the risk of complications such as heart attack and stroke.
In this study we are comparing two different ways of organising health care for people with diabetes. One method is for GPs and practice nurses to work with colleagues in hospital. Another is to provide community based clinics for diabetes (sometimes known as intermediate care clinics) which act as a 'bridge' between practices and the hospital. The aim of this study is to find out which method of care is more effective in helping patients with diabetes achieve the best control possible of their disease
4 - Why have I been chosen?
Your practice is taking part in this study and will soon be allocated by chance to one of the two methods of care we are comparing. The practice is inviting its adult patients with type 2 diabetes to take part.
5 - Do I have to take part?
No. It is up to you to decide whether or not to take part. If you do, you are still free to withdraw at any time and without giving a reason.
6 - What will happen to me if I do not take part?
A decision not to take part will not affect the care you receive or whether your doctor suggests referral to a community clinic or hospital.
7 - What will happen to me if I take part?
After the study has started you will be asked to attend for two assessments, the first at the beginning of the study and the second 18-24 months later. The first assessments will take place within the next few weeks and at that time a research nurse will explain the study to you in more detail and ask you to confirm your consent in writing. At both assessments the research nurse will check your weight, blood pressure and waist circumference and ask you to complete some questionnaires. You will also be asked to provide a sample of 10 ml blood (2 teaspoons) and a similar amount of urine to assess how well controlled your diabetes is. Both assessments will take place in your general practice or at your home if you are housebound. It is very important that as many people as possible who attend the first assessment also attend the second, otherwise we may not be able to tell which method of care is more effective. We will also ask you for permission to look at your medical notes to find out, for example, how many times you saw your doctor or nurse. Each assessment will take up to an hour.
At the end of the study you may be invited to participate in a more detailed interview about what you think about the care you have received. If you are selected you will receive more detailed information at the time and be asked to complete a further consent form.
8 - What will happen if I don't want to carry on with the study?
You can withdraw from the study at any time, and this will not affect the care you receive. If you decide not to attend the second assessment we will ask you whether you are still prepared to allow us to look at your health records and complete a questionnaire.
9 - What are the possible disadvantages and risks of taking part?
The only disadvantage is the time you have given up to attend the assessments, and the slight pain you may feel when giving blood.
10 - What are the possible benefits of taking part?
We cannot promise the study will help you but the information we get might help improve the organisation of care of people with diabetes.
11 - What happens when the research study stops?
There will be no immediate change in the way your practice organises its care for people with diabetes after the trial has stopped. In the longer term results may influence how care is organised.
12 - Expenses and payments
You will be able to claim for any additional expenses incurred through attending the assessments.
13 - Will my taking part in the study be kept confidential?
Yes. All information which is collected about you during the course of the research will be kept strictly confidential. Any information about you which leaves the practice will have your name and address removed so that you cannot be recognised from it.
14 - Complaints
If you have a concern about any aspect of this study, you should ask to speak with the researchers who will do their best to answer your questions. If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure.
15 - Harm
In the event that something does go wrong and you are harmed during the research study there are no special compensation arrangements. If you are harmed and this is due to someone's negligence then you may have grounds for a legal action for compensation against the University of Leicester but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you. NHS and University Indemnity do not offer no-fault compensation i.e. for non-negligent harm, and NHS bodies are unable to agree in advance to pay compensation for non-negligent harm.
16 - What will happen to any samples I give?
The blood samples taken as part of the research will be treated in the same way as those taken by the practice. Results from your blood and urine tests, your blood pressure, height and weight measurements will be made available to your doctor, to contribute to your ongoing care. Samples will be destroyed after analysis, according to the laboratory's usual practice.
17 - What will happen to the results of the research study?
Results will be presented to NHS managers to help them decide how to arrange care. Findings will also be written for publication in scientific journals and presented at conferences. If you are interested in knowing the results you will be able to see them on the study's website.
18 - Who is organising and funding the research?
The study if funded by the NHS Service Delivery and Organisation research and development programme. Your doctor will be paid only for the additional costs incurred by participating in the study
19 - Contact Details
If you are interested in taking part and would like to ask a question, please contact Miss Ainsley Hardy, Department of Health Sciences, University of Leicester, 22-28 Princess Rd West, Leicester LE1 6TP
Telephone: +44 (0)116 252 5473 or contact by e-mail