Why are you doing this research?

We want to help people with mild cognitive impairment. We don’t yet know the best way to show and measure the usefulness of a new treatment or way of supporting someone with mild cognitive impairment. We would like to create a list of things that people agree are important to collect and measure in research that aims to help people with mild cognitive impairment.   

Do I have to join in?

No, you do not have to join in. Please feel free to talk to your family or friends about the research to help you decide. If you say no, you will continue to receive the same healthcare for your mild cognitive impairment. If you say yes, you can change your mind later. You can drop out at any time.

What will it involve?

If you say yes, we will start by asking when you were diagnosed with mild cognitive impairment and if anything has changed since your diagnosis.

If we think it is OK for you to take part, we will ask you to complete a consent form (online or on a paper form) to say that:

• You understand what the study involves and would like to take part.
• You are happy for us to access your medical records to confirm you received a formal diagnosis of MCI in the past year.
• You agree for your data to be used in another study and that you can be contacted to hear about future research opportunities (optional). 

We will then ask you some brief questions about yourself such as how old you are and where you’re from.

We will ask you to talk with a researcher about what things you think are important to measure in mild cognitive impairment research. This can be done in person or by video call (online) and will take 30-45 minutes. 

This interview will be audio-recorded, so we have a record of what you’ve told us. Once we’ve transcribed (written down) what you said in the recording, we will delete the audio recording. As a thank you for completing the interview, we will offer you a £10 voucher.

After other people in the study have completed their interviews, you will be asked to complete two surveys. These surveys are to see if people agree on what they think are the most important things to measure in mild cognitive impairment research. You can complete these surveys online or on a paper form. As a thank you, people who complete both surveys will be offered a £10 voucher.

You may be asked to take part in a meeting (online or in person) a few weeks or months later. In this meeting we will talk about anything that people seemed to disagree about in the surveys. We will decide together what the most important things we should measure in research. As a thank you, people who take part in this meeting will be offered a £10 voucher.

Do I need someone to be with me or help me during the surveys and/or interview?

No. You can complete the study without a ‘study partner’. If you would like someone to sit with you whilst you complete the study tasks, they can.

We will ask anyone who accompanies you to try not to influence what you tell us or the decisions you make. 

What are the good things about being on the study?

The research will help us to improve research and healthcare to better support and treat people with mild cognitive impairment.

The study can be completed remotely from your own home. We can reimburse you for reasonable travel expenses (if you prefer to attend the clinic for an in-person interview) and can provide audio equipment for video calls.

What are the bad things about joining in?

Taking part will take up some of your time.

Will you tell my GP I’m involved in the study?

At the start of the study, we will ask if you think there has been any changes to your thinking and memory since your diagnosis. If you think things have become more difficult, we will ask if you would like us to contact your GP about your symptoms.

We will only let your GP know if you are taking part in the study if you agree to this and want us to contact your GP on your behalf.

We will also ask you if you would like us to put a copy of your consent form for this study on your medical records, but this is also optional.

How will we use information about you?

We will need to use information from you and your medical records for this research project.

This information will include your name, NHS number, contact details, and information such as your age, sex, details of your MCI diagnosis, and ethnicity. People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

We will keep all information about you safe and secure.

We will share what we learn from the study with others, but no one will be able to identify you from this data. When the research is finished, we will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. 
• We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you. 
• If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

• at hra.nhs.uk/information-about-patients/
• by asking one of the research team
• by sending an email to gabb@bristol.ac.uk
• by ringing us on 0117 456 0700
• by sending contacting our Data Protection Officer by emailing data-protection@bristol.ac.uk or by calling 0117 394 1824.

What if something goes wrong or I want to complain?

If you wish to complain about the study, please contact the research team (details at the end of this information sheet) or the Sponsor of the study, University of Bristol, by emailing research-governance@bristol.ac.uk or by calling 0117 428 3065. 

What should I do now?

If you would like to ask a question or think you would like to take part, please contact the research team:

Victoria Gabb (MCI Core Outcomes Study)

victoria.gabb@bristol.ac.uk

0117 456 0700