Epilepsy Nurse Trial for adults with ID (01)
Research type
Research Study
Full title
Improving outcomes in adults with epilepsy and intellectual disability: A cluster randomised controlled trial of nurse-led epilepsy management (EpAID)
IRAS ID
129038
Contact name
Howard Ring
Contact email
Sponsor organisation
Cambridgeshire and Peterborough NHS Foundation Trust
ISRCTN Number
ISRCTN96895428
Research summary
1. The trial is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (Number 10/104/16).
2. The primary aim of the trial is to establish whether nurses with expertise in epilepsy and intellectual disabilities (ID), working to a defined competency-based clinical role, can improve clinical outcome, as measured by the Epilepsy Quality of Life seizure severity scale, in the management of epilepsy in adults with (ID), when compared to treatment as usual. The main secondary aim will be to establish whether any perceived benefits represent good value for money after consideration of the costs associated with the intervention.
3. The trial will be based in community ID teams and in the communities that they support.
4. The trial will follow a cluster-randomised design, with 12 clusters spread around the UK. Within each cluster 34 adults (aged 18-65) with an intellectual disability (IQ ≤ 70) and epilepsy (with at least one seizure in the preceding six months) will be recruited. Six clusters will be randomized to the novel epilepsy nurse intervention and six clusters will be randomized to a treatment as usual control condition. In each cluster there will be five sets of qualitative interviews and five observed clinical encounters.
5. Participants will each be enrolled in the trial for eight months, comprising one month of baseline observations and seven months of treatment according to the trial protocol. Outcomes will be assessed during the final month of treatment.
6. Outcome measures to be compared between the treatment arms will include seizure severity and frequency; quality of life; carer strain; service user, carer and clinician perceptions of treatment; economic costs of epilepsy care and any changes in health or social care resource use.
7. The duration of the project will be 32 months.
REC name
London - Queen Square Research Ethics Committee
REC reference
14/LO/0055
Date of REC Opinion
10 Feb 2014
REC opinion
Further Information Favourable Opinion