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NCT Number: NCT06780501

Neuropsychiatric Research Databases for People With Intellectual Disabilities and Epilepsy (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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cornwall Partnership NHS Foundation Trust, Bodmin, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: End of study (May 2025)

    De-identified database

  2. 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.

    Time frame: End of study (May 2025)

    Research register

Secondary outcomes

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

    Time frame: End of study (May 2025)

    Feasibility objective

  2. Completeness of clinical data collected (De-identified database)

    Time frame: End of study (May 2025)

    Feasibility objective

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

    Time frame: End of study (May 2025)

    Feasibility objective

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

    Time frame: End of study (May 2025)

    Feasibility objective

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

    Time frame: End of study (May 2025)

    Feasibility objective

  6. Set up of a formal process including the REFINE Study Oversight Committee to review requests for access to the participant register (Research register).

    Time frame: End of study (May 2025)

    Feasibility objective

  7. Completeness of clinical data collected (Research register).

    Time frame: End of study (May 2025)

    Feasibility objective

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Stanyard

CONTACT

[email protected]

+44 (0) 1752 439831

Rohit Shankar

CONTACT

[email protected]

+44 (0) 1752 439831

Sponsors and collaborators

Lead sponsor

University of Plymouth

Other

Registry information

Acronym: REFINE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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