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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Intellectual Disability; Learning Disability

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Emily Stanyard; Phone Number: +44 (0) 1752 439831; Email: emily.stanyard@plymouth.ac.uk
• Study Contact Backup: Name: Rohit Shankar; Phone Number: +44 (0) 1752 439831; Email: rohit.shankar@plymouth.ac.uk

Study Locations

• United Kingdom
  • Bodmin, United Kingdom
    • Recruiting
    • Cornwall Partnership NHS Foundation Trust
    • Contact: Sarah Lennard
    • Principal Investigator: Sarah Lennard
  • London, United Kingdom
    • Not yet recruiting
    • Royal Free London Hospitals NHS Trust
    • Contact: Heather Angus-Leppan
    • Principal Investigator: Heather Angus-Leppan
  • Swansea, United Kingdom
    • Recruiting
    • Swansea Bay University Health Board
    • Principal Investigator: Lance Watkins
    • Contact: Lance Watkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

The de-identified database:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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).

Exclusion Criteria:

- Other neurodevelopmental disorders without ID.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of eligible patients identified at each site for data collection (De-identified database).	Feasibility objective	End of study (May 2025)
Completeness of clinical data collected (De-identified database)	Feasibility objective	End of study (May 2025)
Feedback collected from sites about any issues around identifying patients and locating the data required (De-identified database).	Feasibility objective	End of study (May 2025)
Screening and recruitment rates at each site (Research register).	Feasibility objective	End of study (May 2025)
Successful recruitment process in place at each site (Research register).	Feasibility objective	End of study (May 2025)
Set up of a formal process including the REFINE Study Oversight Committee to review requests for access to the participant register (Research register).	Feasibility objective	End of study (May 2025)
Completeness of clinical data collected (Research register).	Feasibility objective	End of study (May 2025)

Collaborators and Investigators

• Sponsor: University of Plymouth
• Collaborators: Peninsula Clinical Trials Unit
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Intellectual Disability; Epilepsy; Learning Disabilities
• Other Study ID Numbers: 5284

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No