Seizure first Aid training For Epilepsy: intervention development and pilot RCT

1. Intervention development phase of project:
Not applicable.

2. Pilot RCT phase of project:
The pilot will not be powered to detect a clinically meaningful difference in outcome between treatment groups, summary statistics will be calculated to measure the effect of the intervention on the proposed primary and secondary outcome measures for a future definitive trial and the precision of such estimates at the post-treatment time points.

3. Proposed primary outcome measure:
The number of epilepsy-related emergency department (ED) visits made over the 12 months following randomisation by patient participant. This will be measured using routinely collected NHS data. The Hospital Episode Statistics (HES) system provides a central record of an individual’s use of all EDs in England and data will be extracted from this system (using participants’ NHS numbers) to provide information on individual participants’ use of ED at baseline and over the 12 months of follow-up. HES data will be requested at the start of Project Month 32 in a single tranche.

1. Intervention development phase of project:
Not applicable.

2. Pilot RCT phase of project:
Secondary measures will be based on participant self-report measured using standardised questionnaires. Patient participants will be requested to complete self-report measures prior to randomisation (T0) and then 3(T1), 6(T2) and 12-months (T3) post randomisation. Carer participants will be requested to complete self-report measures prior to randomisation (T0) and then 6 (T2) and 12months (T3) post randomisation. Baseline (T0) and 12 month (T3) follow-up measures will be collected in face to face
sessions by a research worker, blind to treatment allocation. Abbreviated assessments will occur at 3 months (T1) and 6 months (T2). The 3 month assessment will be conducted by telephone. For the 6month follow-up assessment (T2), participants will be posted a set of questionnaires for completion.

3. The following self-report outcomes will be collected from participants:
3.1. Self-reported epilepsy-related ED visits (Patients only; T0, T2, T3)
3.2. Quality of life (Patients only; T0, T2, T3); using Quality of Life in Epilepsy Scale-31 (QOLIE31)
3.3. Caregiver burden (Carers only; T0, T2, T3); using Zarit Caregiver Burden Inventory
3.4. Distress (Patientsand Carers; T0, T3); using Hospital Anxiety and Depression Scale
3.5. Stigma due to epilepsy (Patients only; T0, T3); using Jacoby’s 3-item Stigma of Epilepsy Scale;
3.6. Fears of seizures and epilepsy (Patients and Carers; T0, T3); using 5-items from Fears subscale of the Epilepsy Knowledge and Management Questionnaire
3.7. Confidence managing seizures/ epilepsy (Patients and Carers; T0, T2, T3); Patients will complete Wagner's 6-item epilepsy specific Mastery scale, whilst carers will complete the 6-item Condition Management subscale from Austin’s Parents Response to Child Illness Scale
3.8. Seizure frequency (Patients only; T0, T1, T3); At baseline (T0), patients will be asked to complete Thapar’s seizure frequency scale for the prior 12 months. At 6 (T2) and 12 months (T3) follow up, PWE will be asked for the number of seizures (of any type) they have experienced since the last assessment and the date of the first and most recent seizure since last assessment. Patients will be provided with a seizure diary at T0
3.9. Knowledge of what to do when faced with a seizure (Patient and Carers; T0, T3); using Martiniuk et al.’s (2007) ‘Thinking About Epilepsy Questionnaire’
3.10. Health economics (Patients only; T0, T3); using the Client Service Receipt Inventory (CSRI)
3.11. Patient Activation Measure (Patients & Carers; T0, T3); using 13-item Patient Activation Measure (PAM).
3.12. Serious Adverse Events (Patients only; T1, T2, T3); A standardised checklist will be used to ask PWE about any new symptoms or diagnoses occurring since randomisation and length of those symptoms.
3.12. Feedback on participation (Patients & Carers, T3); adaptations of questions used in Magpie Trial.