An observational study in Epilepsy, Intellectual Disability and Learning Disability, sponsored by University of Plymouth. Recruiting at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by University of Plymouth · Observational
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 600 is above the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →University of Plymouth is the lead sponsor of 49 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with a clinical diagnosis of an Intellectual Disability (ID) and epilepsy at participating sites.
The de-identified database:
Inclusion Criteria:
Exclusion Criteria:
The research register:
Inclusion Criteria:
Exclusion Criteria:
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
Time frame: 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
Time frame: End of study (May 2025)
Numbers of eligible patients identified at each site for data collection (De-identified database).
Feasibility objective
Time frame: End of study (May 2025)
Completeness of clinical data collected (De-identified database)
Feasibility objective
Time frame: 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
Time frame: End of study (May 2025)
Screening and recruitment rates at each site (Research register).
Feasibility objective
Time frame: End of study (May 2025)
Successful recruitment process in place at each site (Research register).
Feasibility objective
Time frame: 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
Time frame: End of study (May 2025)
Completeness of clinical data collected (Research register).
Feasibility objective
Time frame: End of study (May 2025)
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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