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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Plymouth

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Clinical diagnosis of ID in medical records.

Clinical diagnosis of epilepsy in medical records.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators