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

Обзор

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.

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: End of study (May 2025)]

Вторичные конечные точки (7)

• Numbers of eligible patients identified at each site for data collection (De-identified database). [Срок оценки: End of study (May 2025)]
• Completeness of clinical data collected (De-identified database) [Срок оценки: End of study (May 2025)]
• Feedback collected from sites about any issues around identifying patients and locating the data required (De-identified database). [Срок оценки: End of study (May 2025)]
• Screening and recruitment rates at each site (Research register). [Срок оценки: End of study (May 2025)]
• Successful recruitment process in place at each site (Research register). [Срок оценки: 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). [Срок оценки: End of study (May 2025)]
• Completeness of clinical data collected (Research register). [Срок оценки: End of study (May 2025)]

Критерии участия

The de-identified database:

Критерии включения

• 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.

Критерии исключения

• 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:

Критерии включения

• 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).

Критерии исключения

\- Other neurodevelopmental disorders without ID.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 3 центра

• Cornwall Partnership NHS Foundation Trust — Bodmin
• Royal Free London Hospitals NHS Trust — London
• Swansea Bay University Health Board — Swansea

Публикации

• Musicha C, Neilens H, Stanyard E, Allgar V, Lomax J, Ashford R, Hambly H, Aspinall P, O'Shaughnessy E, Rollinson C, Lennard S, Mclean B, Simpson A, Bowman P, Angus-Leppan H, Watkins L, Laugharne R, Allard J, Shankar R. Neuropsychiatric research databases for people with intellectual disabilities and epilepsy (REFINE): a feasibility study protocol. BMJ Open. 2025 Nov 26;15(11):e108869. doi: 10.1136 PMID 41298255

Идентификаторы

NCT: NCT06780501 · 5284

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗