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

NCT06780501 | Recruiting

• 1 other identifier: 5284
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Epilepsy; Intellectual Disability; Learning Disability

Outcome Measures

Primary Outcomes (2)

• The set up of a research database consisting of de-identified data focused on People with Intellectual Disabilities (PwID) and epilepsy at three UK NHS sites across England and Wales.

  De-identified database

  End of study (May 2025)

• The development of a research register of PwID and epilepsy. Participants will consent to the collection of their personal/clinical data, which will enable the identification of patients willing to take part in other ethically approved research projects.

  Research register

  End of study (May 2025)

Secondary Outcomes (7)

• Numbers of eligible patients identified at each site for data collection (De-identified database).

  End of study (May 2025)

• Completeness of clinical data collected (De-identified database)

  End of study (May 2025)

• Feedback collected from sites about any issues around identifying patients and locating the data required (De-identified database).

  End of study (May 2025)

• Screening and recruitment rates at each site (Research register).

  End of study (May 2025)

• Successful recruitment process in place at each site (Research register).

  End of study (May 2025)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a clinical diagnosis of an Intellectual Disability (ID) and epilepsy at participating sites.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Clinical diagnosis of ID in medical records.
• Clinical diagnosis of epilepsy in medical records.
• Under the current care of specialist ID or epilepsy services at one of the three participating NHS Trusts.
• Between the ages of 18 and 30 at the time of consent.
• Participant has the capacity to be able to provide consent for themselves, or a personal consultee is able to provide an opinion on the views and feelings of the potential participant.
• Patients (or personal consultee) must be able to communicate in English (or Welsh in Welsh site).
• \- Other neurodevelopmental disorders without ID.

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (3)

Cornwall Partnership NHS Foundation Trust

Bodmin, United Kingdom

RECRUITING

Royal Free London Hospitals NHS Trust

London, United Kingdom

NOT YET RECRUITING

Swansea Bay University Health Board

Swansea, United Kingdom

RECRUITING

Related Publications (1)

• Musicha C, Neilens H, Stanyard E, Allgar V, Lomax J, Ashford R, Hambly H, Aspinall P, O'Shaughnessy E, Rollinson C, Lennard S, Mclean B, Simpson A, Bowman P, Angus-Leppan H, Watkins L, Laugharne R, Allard J, Shankar R. Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol. BMJ Open. 2025 Nov 26;15(11):e108869. doi: 10.1136/bmjopen-2025-108869.

  PMID: 41298255 DERIVED

MeSH Terms

Conditions

Epilepsy; Intellectual Disability; Learning Disabilities

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders

Study Officials

• Lance Watkins

  Swansea Bay University Health Board

  PRINCIPAL INVESTIGATOR

• Sarah Lennard

  Cornwall Partnership NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Heather Angus-Leppan

  Royal Free London NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohit Shankar

CONTACT

+44 (0) 1752 439831; rohit.shankar@plymouth.ac.uk

Emily Stanyard

CONTACT

+44 (0) 1752 439831; emily.stanyard@plymouth.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Neuropsychiatry

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: January 17, 2025
• Study Start: September 12, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-09

Locations

GB (3)