RecruitingOBSERVATIONAL

Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (REFINE)

This study, called REFINE, has two main parts. The first part involves creating a secure database using anonymous medical information from people with intellectual disabilities and epilepsy across three NHS sites. This helps researchers see if they can easily gather the right information. The second part creates a register of people who agree to share their personal and medical details so they can be contacted for future research studies. The goal is to make it easier for scientists to work together, share information, and ultimately improve care for people living with these conditions. It's about laying the groundwork for more important research in the future.

At a glance

Status

Recruiting

Sponsor

University of Plymouth

Enrolment target

600

Start

12 Sep 2024

Estimated completion

31 May 2025

Epilepsy Intellectual Disability Learning Disability

What is this study about?

This study, called REFINE, is looking into how we can do better research for people in the UK who have both an intellectual disability and epilepsy. It's a really important step because these conditions can be complex, and good research needs good information to start with.

There are two main parts to the REFINE study. The first part is about building a secure database of medical information from people with intellectual disabilities and epilepsy. Don't worry, all personal details that could identify someone are removed from this data, so it's completely anonymous. Researchers will look at existing medical records from three NHS hospitals in England and Wales to gather details about people's epilepsy and the medicines they take. This helps them learn if it's possible to collect all the necessary information and spot any difficulties so they can plan bigger studies in the future.

The second part of REFINE is creating a research register. This is for people with intellectual disabilities and epilepsy who are happy to be contacted about future research studies. If you agree to be on this register, researchers will collect some of your personal and medical details from your health records. This register will make it much easier for different research teams across the country to find people who might be suitable for their studies, helping to speed up medical discoveries and improve care. Your information will only ever be shared for ethically approved research projects.

Key takeaways

This study aims to improve research for people with intellectual disabilities and epilepsy.
It collects anonymous information from medical records for a database.
It also creates a register for people who agree to be contacted for future studies.
No new treatments or tests are involved in this study.
Your privacy is protected, and you can withdraw from the register at any time.
Your involvement helps pave the way for better understanding and care.

Who may be eligible?

For the anonymous database part of the study, you would be included if you are over 18, have a diagnosis of both intellectual disability and epilepsy in your medical records, and are currently being cared for by a specialist team at one of the three participating NHS hospitals. You would not be included if you have other brain-related conditions without an intellectual disability, or if you have previously said you don't want your NHS data used for research.

For the research register part, you need to be between 18 and 30 years old, with diagnoses of intellectual disability and epilepsy, and cared for by a specialist team at one of the three NHS hospitals. You would also need to be able to understand and give your own permission to join, or have a family member or friend who can speak for you. Being able to communicate in English (or Welsh if at a Welsh site) is also important.

It's important to know that this study is not looking for people with other developmental conditions if they don't also have an intellectual disability.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a diagnosis of intellectual disability?
Do you also have a diagnosis of epilepsy?
Are you currently cared for by an NHS specialist team for these conditions?
Are you between the ages of 18 and 30? (For the register part only)
Can you or a family member/friend who knows your wishes give permission?
Do you communicate in English (or Welsh if in Wales)?

Answer every question to see your result.

What does participation involve?

If you are included in the first part (the anonymous database), you won't need to do anything yourself. Researchers will simply use de-identified information from your existing medical records. This means they will remove all details that could identify you, like your name or address, before they use it for the study. There are no visits, assessments, or changes to your medication involved for you.

If you agree to be part of the second part (the research register), a researcher will speak with you (or your close family member/friend if you need support with decisions) to get your permission. They will then collect relevant personal and medical details from your health records. You won't have extra appointments or tests for this part either. The main involvement is giving your consent and agreeing to be contacted by researchers about other potential studies in the future. The total duration of your participation in the register would be ongoing, for as long as you wish to be included.

Potential risks and benefits

There are no direct medical benefits or risks to you for taking part in this study, as it primarily involves using existing information. The main benefit is knowing you are helping to improve research and understanding of intellectual disabilities and epilepsy, which could lead to better care for people in the future. For the anonymous database, your privacy is protected as all identifying details are removed. For the research register, your personal data will be collected, but it will only be used for approved research projects, and your consent is essential. You are always free to change your mind and withdraw your permission from the register at any time without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cornwall Partnership NHS Foundation Trust
Verified postcode
Bodmin, United Kingdom· Recruiting
Royal Free London Hospitals NHS Trust
Verified postcode
London, United Kingdom· Not yet recruiting
Swansea Bay University Health Board
Verified postcode
Swansea, United Kingdom· Recruiting

Common questions

What is an 'intellectual disability'?

An intellectual disability means a person has some difficulty with their learning and understanding. This might mean they need more support with daily tasks than others of their age.

What does 'de-identified' mean?

This means that all your personal information, like your name, address, and date of birth, is removed from your data so no one can tell who it belongs to. It's made anonymous.

Will I have to take new medicines or have extra tests?

No, this study does not involve any new medicines, treatments, or extra medical tests. It only uses information already in your medical records.

If I join the register, do I have to join every future study?

No, definitely not. Joining the register simply means researchers can contact you about future studies. You can always say 'no' to any study, and it will not affect your care.

Who will see my information?

For the anonymous database, researchers will see your medical details but without anything that identifies you. For the register, approved researchers will see your relevant information, but only if you have consented for it to be used for research.

How to find out more

Rohit Shankar

rohit.shankar@plymouth.ac.uk +44 (0) 1752 439831 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.