Background: In adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in\nmanagement may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive\nclinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe\nand to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with\nexpertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life\noutcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also\naims to establish whether any perceived benefits represent good value for money.\nMethods/design: The EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy\nmanagement versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and\ndrug-resistant epilepsy. Participants are randomly assigned either to a ââ?¬Ë?treatment as usualââ?¬â?¢ control or a ââ?¬Ë?defined\nepilepsy nurse roleââ?¬â?¢ active arm, according to the cluster site at which they are treated. The active intervention\nutilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with\nID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention\n(novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is\nseizure severity, including associated injuries and the level of distress manifest by the patient in the preceding\n4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects.\nDescriptive measures include demographic and clinical descriptors of participants and clinical services in which they\nreceive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with\nclinicians and participantsââ?¬â?¢ carers are also undertaken Discussion: The EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a\nnurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and\nepilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting\nthese are discussed.
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