Participant information sheet

After reading the eligibility criteria information about the research, if you are considering participating in this study, please read the below information before making a decision.

Are you interested in taking part of this study?

Thank you for showing an interest in this project. Please take time to read this information sheet carefully before deciding whether or not to participate. Feel free to discuss this information with friends, relatives and your GP if you wish.

Please tell us if you wish to take part of the study. Our contact details are given at the end of this information sheet. If you decide not to take part there will be no disadvantage to you of any kind and we thank you for considering our request.

Please ask us if there is anything that it is not clear or if you would like more information.

1. What is the purpose of the study?

Diabetes is a major medical problem in which the body loses control of blood sugar levels. As a result, people with diabetes need long-term treatment to help bring the blood sugars under control. Diabetes can also lead to complications such as heart and kidney disease.

Diabetes in particularly common amongst people of South Asian ancestry, with diabetes affecting almost one-quarter of South Asian men and women. Understanding how to prevent diabetes in South Asians is therefore of great importance.

Diabetes can be prevented or delayed by adopting a healthier lifestyle.  Although this is good news, it is not clear which people benefit most from lifestyle change, or the best way to improve healthy living amongst South Asians.

We will be comparing differing approaches to screening South Asian people for risk of developing diabetes (we will be comparing blood tests with measures of fatness). We will also be assessing the effectiveness of established, alternative approaches to promoting healthy living (we will be comparing extended, intensive approaches with conventional, brief approaches).

2. Why have I been invited?

You recently attended a screening visit for assessment of your risk of developing diabetes. Your results suggest that you may be at high risk of developing diabetes in the future.

3. Do I have to take part?

Not if you don’t want to. It is up to you to decide. We will describe the study and go through this information sheet, a copy of which will be yours to keep. If you agree to take part, we will ask you to sign a consent form. You are free to withdraw at any time, without giving a reason. This would not affect the medical care you receive.

4. What will happen to me if I take part?

You will be asked to attend Ealing Hospital for one visit lasting about one hour. This visit will be similar to the screening visit that you recently attended.

We will go through this information sheet and explain the study to you. You will receive a copy of this information sheet, which you can keep. We will answer any questions you may ask about the study. If you agree to take part, you will be asked to sign a consent form, a copy of which will be yours to keep.

After you have signed the consent form, we will ask you to complete a questionnaire about yourself and your health. This will ask questions about things like medical problems you may have had and medications that you may be taking. A member of the research team will be available to help you answer these questions. As part of the research we may need to review your medical notes so that we can confirm the medical details of any suspected health problems that you tell us about. We would like your permission to do this.

Next we will take some measurements from you. These will be measurements of your height, weight, blood pressure and waist size. After that we will take a small blood sample (30mls, approximately 2 tablespoons) This will be sent for measurement of blood sugar and blood fats to diagnose diabetes, and for high blood fats which are a risk factor for heart disease. Some of the blood will be stored for future testing, including tests for genetic factors that may lead to diabetes and other major medical problems. The goal of this aspect of the research is to find new ways of predicting and preventing diabetes. More information on this is given in Part 2.

After these tests have been carried out, you will be free to go home. You will get a copy of your test results once they are available (typically within one week).

If your test results confirm that you are at risk of diabetes we will invite you back for healthy living advice to help you prevent or delay diabetes. This will comprise 9 face-face sessions, each lasting for about one hour, delivered by a trained health educator. The health educator will review your eating and exercise habits and give you advice on how to improve these for the future. The 9 face-face meetings will be spread out over the course of one year and are designed to give you intensive help with lifestyle change. Some of the face-face meetings will involve group activities. In addition, there will be ~12 phone-calls at intervals over the year to reinforce the advice given in the face to face meetings. . Face to face meetings take place twice in the first month, then once a month until month 6, then in months 9 & 12. The telephone calls are interspersed with these visits.

After the healthy living advice session is complete we will ask you to come back for annual monitoring for the duration of 3 years, so that we can assess the impact of the lifestyle advice. This will include testing you for development of diabetes so that you detect early whether your condition has progressed.

Your future treatment will not be affected by participating (or not participating) in this study.

5. Expenses and Payments

We are happy to reimburse your travel expenses to and from Ealing hospital.

6. What will I have to do?

First we will ask you to come to Ealing Hospital for an appointment lasting about one hour. You will need to come fasting (nothing to eat or drink except water for 8 hours prior to the appointment).

At the visit we shall ask you to do the following:

  • Read this information sheet, ask us any questions you like, and sign a consent form
  • Complete a questionnaire about your health and lifestyle
  • Allow us to measure your height, weight and blood pressure
  • Allow us to take a small blood sample

If your test results confirm that you are at risk of diabetes we will invite you back for healthy living advice to help you prevent or delay diabetes. This will comprise 9 face-face sessions, each lasting for about one hour, delivered by a trained health educator. The health educator will review your eating and exercise habits and give you advice on how to improve these for the future. The 9 face-face meetings will be spread out over the course of one year and are designed to give you intensive help with lifestyle change. Some of the face-face meetings will involve group activities. In addition, there will be ~12 phone-calls at intervals over the year to reinforce the advice given in the face to face meetings. The timetable for the face-face meetings and telephone calls is shown above.

After the healthy living advice session is complete we will ask you to come back for annual monitoring so that we can assess the impact of the lifestyle advice. This will include testing you for development of diabetes so that you detect early whether your condition has progressed. There annual follow-up appointments will last about an hour and will again be held at Ealing Hospital.

7. What are the possible disadvantages and risks of taking part?

You may experience some mild discomfort from the blood test. No other risks are expected from the appointment.

There is a chance that your results will show a significant abnormality of which you were unaware. In such circumstances you will be referred to the appropriate specialist in consultation with your GP, if that is what you would like. Such detection has the benefit of starting treatment early, but in a small number of cases may have implications for future employment and insurance.

8. What are the side-effects of any treatment received when taking part

If your results show that you may be at risk of developing diabetes, then we will invite you back to offer you lifestyle advice to help you prevent or delay development of diabetes. We do not anticipate any side-effects from healthy lifestyle advice.

9. Ionizing radiation

There is no radiation involved in this study.

10. Harm to the unborn child

Women of child-bearing age may participate in this study without risk, as the study does not involve treatment, invasive procedures or ionizing radiation. Women who are pregnant though should defer their research study appointment until 3 months after the baby is born, as pregnancy has a number of effects on blood pressure, blood sugar and blood fats that make the research results difficult to understand.

11. What are the possible benefits of taking part?

If your results show that you may be at risk of developing diabetes, you will receive lifestyle advice to help you prevent or delay development of diabetes. After this you will get detailed annual monitoring; this will enable early detection and treatment should diabetes develop.

The tests may also reveal health problems about which you were previously unaware, for example high blood cholesterol level, high blood pressure or heart problems. Such detection has the benefit of starting treatment early, which will help you to avoid complications. We cannot promise the study will help you personally, but the information we get from this study will help improve the prevention and treatment of heart attack and stroke in the wider community, in the future.

12. What happens when the research study stops?

We plan to follow your health through NHS and General Register Office records over the long term. This may be 20 or more years. Once the research is completed the data and results will be made fully anonymous (ie all personal information removed), and available for use by other researchers. Any remaining blood samples will be destroyed.

13. What if there is a problem?

Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. The detailed information on this is given in Part 2.

14. Will my taking part in the study be kept confidential?

Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2.

If the information in Part 1 has interested you and you are considering participation, please read the additional information in Part 2 before making any decision.

Part 2

More detail – information you need to know if you still want to take part

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

You are free to withdraw from the study at any time. Please talk to any member of the research team if you wish to withdraw. The research team may ask you why you are leaving the study. Explaining why will help us to design future studies. However, you do not have to give any reasons for your withdrawal if you do not want to.

If you withdraw from the study, we will destroy all your identifiable samples, but we may need to use the data collected up to your withdrawal. For example, where samples and data have been anonymised, we will not know the identity of the person who gave any particular sample. If data has been publicly shared on scientific databases we also will not be able to retrieve it.

2. What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (Professor Kooner and Professor John Chambers can both be contacted on 020 8967 5000). If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from the hospital.

Imperial College London holds insurance policies which apply to this study.  If you experience serious and enduring harm or injury as a result of taking part in this study, you may be eligible to claim compensation without having to prove that Imperial College is at fault.  This does not affect your legal rights to seek compensation.

If you are harmed due to someone’s negligence, then you may have grounds for a legal action.  Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Professor Jaspal S Kooner, Consultant Cardiologist, Ealing Hospital, Uxbridge Road, Middx UB1 3HW).  The normal National Health Service complaints mechanisms are also available to you.  If you are still not satisfied with the response, you may contact the Imperial AHSC Joint Research Compliance Office.

3. Will my taking part in this be kept confidential?

We will keep your information in confidence, and in a way that meets the security criteria set by the Data Protection Act 1988. Professor John Chambers will act as the custodian of the data.

Your research data will be anonymised (all personal information removed). Only your research doctors will have access to the key matching anonymous numbers with personal information. This means we will only tell those who have a need or a right to know (eg authorised persons such as research regulatory authorities). Wherever possible, we will only send out information that has your name and address removed.

The study duration is 5 years, however ate the end of the study we expect to preserve the data and samples for 20 years. Once the research is completed, the data and results will be made fully anonymous (ie the key matching research data and samples to personal information will be destroyed). The fully anonymised data may be available for use by other researchers.

4. Involvement of your GP.

We would like to inform your GP that you have taken part in the study, but will only do this if you agree. We will also provide you with a copy of your key test results (such as high blood sugar levels requiring treatment) for you to give to your GP if you wish.

5. What will happen to any samples that I give?

As part of this study we wish to store small amounts of blood for future testing. The samples will be used to try to identify new ways of predicting and preventing diabetes and other major medical problems. Professor John Chambers will act as the custodian of the samples.

Your samples will be anonymised (all personal information removed). Only your research doctors will have access to the key matching the anonymous samples with personal information. This means we will only tell those who have a need or a right to know (eg authorised persons such as research regulatory authorities). Your samples will be kept in secure databases freezers. They will only be accessible to authorised researchers.

Because technology and analysis tools develop all the time, it isn’t possible to give you an exact list of everything that might be done with your samples/information in the future. Our aim is always to work towards the benefit of patients and communities.  In doing so, we may feel it is beneficial to work with other hospitals, universities, research institutes, pharmaceutical and bio-technology companies, including organisations in other countries. They may have expertise, technology, and resources unavailable to us, which would be helpful in driving research forward to everyone’s benefit.  However, we won’t share your information with any other organisation unless it is anonymised ie the information can’t be traced back to you.

If we find out information which has implications for your future health or healthcare, or which we believe impacts on your interests, we will feed this back to. If you would rather not know, you have the option not to be told.  If however your samples/information are put into fully anonymised form, you must understand that it will then no longer be possible to feed back specific results to you and any testing/research done will not be available to you.

The role of an individual sample/set of information in any commercial project is likely to be minimal and impossible to quantify.  Therefore it is not possible to trace back any benefit to individual donors and you should regard participation in the project as being for the benefit of the community at large.  No financial benefits from exploiting the results of the study will come back to you.

The study duration is 5 years, however ate the end of the study we expect to preserve the data and samples for 20 years. Once the research is completed, any remaining blood samples will be destroyed.

6. Will any genetic tests be done?

Some of the research and testing on your sample may be genetic in nature as this can be the most powerful way to discover the causes of disease/defects and to treat and deal with these by developing new drugs and treatments. For example we may try to find variants in genes that protect against or increase the risk of heart attack and stroke. This may include “sequencing” the DNA samples to read all the genetic information in it.

Because technology and analysis tools develop all the time, it isn’t possible to give you an exact list of everything that might be done with your samples/information in the future. We will not contact you directly about these individual genetic studies, as this would be impractical given the numbers of persons participating in the research.

As noted above, our aim is always to work towards the benefit of patients and communities.  In doing so, we may feel it is beneficial to work with other hospitals, universities, research institutes, pharmaceutical and bio-technology companies, including organisations in other countries. They may have expertise, technology, and resources unavailable to us, which would be helpful in driving research forward to everyone’s benefit. We will not your information with any other organisation unless it is anonymised ie the information can’t be traced back to you.

There is a small chance that we may find out information from the genetic tests which has implications for your future health or healthcare or which we believe impacts on your interests. Such detection has the benefit of starting treatment early, but in a small number of cases may have implications for future employment and insurance. If you would rather not know the results of these tests, you have the option not to be told. If you would like to know the results, then we will feed them back to, and you will be referred to the appropriate specialist in consultation with your GP, if that is what you would like. If your samples/information have been put into fully anonymised form, you must understand that it will then no longer be possible to feed back specific results to you.

7. What will happen to the results of the research study?

If you wish, you will receive an individual report of medically relevant results from your tests. If you would rather not know, you have the option not to be told.

We plan to publish the overall results of the completed study in medical journals. You will not be identified in any publications. The results of the research may also be shared through open access (public) scientific databases, including internet databases (www.HapMap.org is an example of such an approach). This will enable other researchers to use the data to investigate other important research questions. The results will always be fully anonymised by removing all identifying information (eg name, address, date of birth, NHS numbers).

8. Who is organising and funding the research?

The research is organised by Professor Kooner and Professor Chambers. The research is funded by the European Union. Your doctors will not receive any payment for including you in the study.

9. Who has reviewed the study?

All research in the NHS is looked at by independent group of people, called a Research Ethics Committee to protect your safety, rights, well-being and dignity. This study has been reviewed and given favourable opinion by the Research Ethics Committee.

10. Sponsor

Imperial College London is the main Sponsor for this study. Delegated responsibilities will be assigned to the NHS trusts taking part in this study.

11. What if I have any questions?

For further information about this research project, or if you are unhappy with any aspect of the study, please contact:

Professor Jaspal S Kooner, Consultant Cardiologist, Ealing Hospital, Uxbridge Road, Middx UB1 3HW, telephone 020 8967 5000, fax 020 8967 5007.

Professor John Chambers, Consultant Cardiologist, Ealing Hospital, Uxbridge Road, Middx UB1 3HW, telephone 020 8967 5000, fax 020 8967 5007.