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

NCT06780501 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-01-17

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Plymouth

    lead OTHER

Principal Investigators

  • Lance Watkins · Swansea Bay University Health Board

  • Sarah Lennard · Cornwall Partnership NHS Foundation Trust

  • Heather Angus-Leppan · Royal Free London NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-12
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780501 on ClinicalTrials.gov