Epilepsy and intellectual disability Nervous System Diseases Epilepsy
Conditions
Interventions
The novel intervention to be trialled is a defined competency-based nursing intervention, based on the Epilepsy Specialist Nurse Association (ESNA) EN competency framework for adults with ID. This has
Sponsors
University of Cambridge and Cambridgeshire and Peterborough NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 - 65 years 2. The presence of a developmental intellectual disability with IQ of 70 or less 3. A diagnosis of epilepsy with a history of at least one seizure in the 6 months preceding recruitment into the study (not considered by those managing the epilepsy to have been a non-epileptic seizure)
Exclusion criteria
Exclusion criteria: 1. The presence of a rapidly progressive physical or neurological illness 2. Alcohol or drug dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The seizure severity scale from the Epilepsy in Learning Disabilities Quality of Life (ELDQOL-SSS) instrument. This is completed by carers and provides a detailed measure of the physical severity of seizures experienced in the preceding 4 weeks, including any associated injuries and the level of distress manifest by the patient after a seizure. This will be collected after 6 months in the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost-utility analysis. As part of this economic evaluation clinical demands on other health agencies, including GP, community ID team, Accident and Emergency and neurology services, will be determined, with data recorded using the Client Service Receipt Inventory over the final 2 months of participation in the trial. 2. Carer Strain Index. This will measure the effect of the intervention on carers and patients after 6 months in the trial. 3. EQ-5D, collected after 6 months in the trial, will be used in conjunction with other data collected to calculate QALYs. This will permit not only a cost-utility analysis but also comparison with the primary outcome measure (ELDQOL-SSS) in terms of sensitivity to change. 4. Carer preferences identified by willingness to pay methods. Mean willingness-to-pay values for each service will provide a measure of the strength of preference across the two service options, collected after 6 months in the trial. 5. Mean number of seizures per month. This will be derived by averaging the number of seizures per month experienced by participants over the final 2 months of the trial period. It is likely that a significant proportion of participants will have more than one seizure type. Seizure frequency data will record number of types of seizures and numbers of each type of seizure. These data will be collected from seizure diaries which participants? family carers or paid support workers will complete daily. (The keeping of seizure diaries is a routine part of epilepsy management and a process likely to already be familiar to those who will be asked to keep these diaries). 6. ELDQoL subscales for side-effects, mood and behaviour collected after 6 months in the trial. 7. A series of qualitative semi-structured interviews of samples of clinicians, family and paid carers which will examine how the competency framework, compared to treatment as usual, impacts on relationships between the EN and family/paid carers with respect to: 7.1. R | — |
Countries
United Kingdom
Outcome results
None listed