At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 8 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2024-09-12
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for epilepsy
- • Clinical study - 600 participants
- • This study consists of two parts: Part One: De-identified Database The goal of this part is to establish a research database containing de-identified data about People with Intellectual Disabilities (PwID) and epilepsy, collected from three NHS sites across England and Wales
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with epilepsy
Where?
- • Bodmin - Cornwall Partnership NHS Foundation Trust
- • London - Royal Free London Hospitals NHS Trust
- • Swansea - Swansea Bay University Health Board
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study consists of two parts: Part One: De-identified Database The goal of this part is to establish a research database containing de-identified data about People with Intellectual Disabilities (PwID) and epilepsy, collected from three NHS sites across England and Wales. Researchers will gather information from participants' medical records, including clinical details, epilepsy history, and medications, and will enter this data into a secure database where all identifying details are removed. This part of the study aims to determine whether it's possible to identify eligible participants, collect complete datasets for each participant, and identify any issues that may affect the quantity and quality of data. These findings will help inform a potential future study that could involve 20 or more sites. Part Two: Research Register The goal of this part is to create a research register of individuals with PwID and epilepsy. Participants will be approached and asked for their consent to collect their personal and clinical data, which will help identify those willing to take part in future ethically approved research projects. As in Part One, researchers will collect data from medical records. Participants who consent to be included in the register may be contacted by external researchers for future studies. The aim is to facilitate national collaboration by enabling data sharing between research projects, thereby improving the ability to answer more questions and enhance patient care. This part of the study will test whether it's possible to determine screening and recruitment rates at each site, develop and evaluate recruitment processes, and assess how researchers leading other approved studies can obtain permission to use the register. Additionally, it will evaluate whether it's possible to collect a complete dataset for each participant.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Clinical diagnosis of ID in medical records.
- ✓Clinical diagnosis of epilepsy in medical records.
- ✓Patient is over the age of 18 years old.
- ✓Under the current care of specialist ID or epilepsy services at one of the three participating NHS Trusts.
Who cannot take part
- ✗Other neurodevelopmental disorders without ID.
- ✗Patient is recorded on the National Data Opt-out as not wishing their data to be used for research/audit.
- ✗The research register:
- ✗Inclusion Criteria:
- ✗Clinical diagnosis of ID in medical records.
See the full criteria
Where Is This Study? (3 UK sites)
Cornwall Partnership NHS Foundation Trust
Bodmin, United Kingdom
Royal Free London Hospitals NHS Trust
London, United Kingdom
Swansea Bay University Health Board
Swansea, United Kingdom
How to Get in Touch
Rohit Shankar
Sponsor contactCONTACT
Emily Stanyard
Sponsor contactCONTACT