跳至主要内容
临床试验/NCT06780501
NCT06780501招募中不适用

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

University of Plymouth3 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
3
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: End of study (May 2025)

De-identified database

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.

时间窗: End of study (May 2025)

Research register

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Rohit Shankar

Professor in Neuropsychiatry

University of Plymouth

研究点 (3)

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