Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol.
Crispin Musicha, Helen Neilens, Emily Stanyard...
https://pubmed.ncbi.nlm.nih.gov/41298255Actively Recruiting
Age: 18Years +
All Genders
ID06780501
Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (REFINE)
Led by University of Plymouth · Updated on 2025-01-17
600
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to develop research databases focused on people with intellectual disabilities (ID) and epilepsy. The study has two parts: first, creating a de-identified database from medical records collected at three NHS sites in England and Wales to assess the feasibility of data collection and quality. Second, establishing a research register of individuals with ID and epilepsy who consent to provide personal and clinical data for future ethically approved research projects, facilitating national collaboration and data sharing. The first part involves gathering clinical details, epilepsy history, and medications from participants' medical records, removing all identifying information before entering the data into a secure database. The second part invites participants to provide consent to be included in a research register, enabling contact about future studies and evaluating recruitment processes, screening rates, and data completeness. Both parts aim to assess feasibility at the participating sites and develop formal procedures for data access and participant identification. Participants will have their medical records reviewed to collect clinical and epilepsy-related data. For the research register, participants or their personal consultees must provide consent and communicate in English or Welsh. Researchers will monitor recruitment and screening efficiency, data completeness, and feedback on challenges with data collection. The study will conclude in May 2025, reviewing the establishment of both the de-identified database and the research register to support future research efforts in this population.
CONDITIONS
Brief Title
Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (REFINE)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of intellectual disability 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 intellectual disability or epilepsy services at one of the three participating NHS Trusts.
- For research register: between the ages of 18 and 30 at the time of consent.
- For research register: participant can provide consent or a personal consultee can provide an opinion.
- For research register: ability to communicate in English or Welsh (in Welsh sites).
You will not qualify if you...
- Other neurodevelopmental disorders without intellectual disability.
- Patient is recorded on the National Data Opt-out as not wishing their data to be used for research or audit.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Diagnostic Evaluation
Duration - Up to the end of the study (May 2025)
Participants consent to the collection of their personal and clinical data for inclusion in research databases and registers focused on intellectual disabilities and epilepsy.
Initial consent visit and periodic data collection through routine care
Long-term Monitoring
Duration - Up to the end of the study (May 2025)
Participants are observed through ongoing data collection to support the development and maintenance of research databases and registers.
Data collection occurs as part of routine healthcare visits without additional participant visits
Trial Site Locations
Total: 3 locations
1
Cornwall Partnership NHS Foundation Trust
Bodmin, United Kingdom
Actively Recruiting
2
Royal Free London Hospitals NHS Trust
London, United Kingdom
Not Yet Recruiting
3
Swansea Bay University Health Board
Swansea, United Kingdom
Actively Recruiting
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Research Team
R
Rohit Shankar
E
Emily Stanyard
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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