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

‘Seizure first Aid training For Epilepsy’ (SAFE) for people with epilepsy who attend emergency departments, and their family and friends: intervention development and pilot.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13871327

Enrollment

207

Registered

2015-04-23

Start date

2015-06-01

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Neurological disorders

Interventions

1. Seizure First Aid Training: The exact content of the 'Seizure first Aid training For Epilepsy' programme will be determined during Part A of the project. Broadly speaking, it will consist of a 3-ho

Study Entry : Single Randomisation only

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PART A OF PROJECT, INTERVENTION DEVELOPMENT Patients with the following characteristics will be eligible to participate in the development phase: 1. Established diagnosis of epilepsy (1+ year) 2.. All epilepsy syndromes and all types of focal and generalised seizures 3. Currently being prescribed anti-epileptic medication 4. Age 16 years or older (no upper age limit) 5. Have visited A&E in the past 2 years for epilepsy (as reported by the patient) 6. Live in the North-West area of England 7. Able to provide informed consent and participate in the course in English Carers with the following characteristics will be eligible to participate in the development phase: 1. A significant other to the patient (e.g., family member, friend) who the patient identifies as providing informal support 2. Age 16 years or older (no upper age limit) 3. Live in the North-West area of England 4. Able to provide informed consent and participate in the course in English PART B OF PROJECT, PILOT RCT Patients with the following characteristics will be eligible for inclusion in the pilot trial: 1. Established diagnosis of epilepsy (1+ year) 2 All epilepsy syndromes and all types of focal and generalised seizures 3. Currently being prescribed anti-epileptic medication 4. Age 16 years or older (no upper age limit) 5. Visited an A&E for epilepsy on 2 or more occasions within the previous 12 months (as reported by patient); 6. Live in the North-West area of England (defined as having a home postcode which indicates they reside within 25 miles of ANY of the 3 ED recruitment sites); 7. Able to provide informed consent, participate in the course and independently complete questionnaires in English. Carers with the following characteristics will be eligible for inclusion in the pilot trial: 1. A significant other to the patient (e.g., family member, friend) who the patient identifies as providing informal support 2. Age 16 years or older (no upper age limit) 3. Live in the North-West area of England 4. Able to provide informed consent, participate in the course and independently complete questionnaires in English Target Gender: Male & Female ; Lower Age Limit 16 years

Exclusion criteria

Exclusion criteria: PART A OF PROJECT, INTERVENTION DEVELOPMENT Patients with the following characteristics will be excluded from the development phase: 1. Acute symptomatic seizures related to acute neurological illness or substance misuse (e.g., alcohol or drug-induced) 2. Severe current psychiatric disorders (e.g. acute psychosis) or life-threatening medical illness Carers with the following characteristics will be excluded from the development phase: a. Severe current psychiatric disorders (e.g. acute psychosis) or life-threatening medical illness; PART B OF PROJECT, PILOT RCT Patients with the following characteristics will be excluded from the pilot trial: 1. Actual or suspected psychogenic non-epileptic seizures alone or in combination with epilepsy 2. Acute symptomatic seizures related to acute neurological illness or substance misuse (e.g., alcohol or drug-induced) 3. Severe current psychiatric disorders (e.g. acute psychosis) or life-threatening medical illness 4. Enrolled in other epilepsy-related non-pharmacological treatment studies Carers with the following characteristics will be excluded from the pilot trial: 1. Severe current psychiatric disorders (e.g. acute psychosis) or life-threatening medical illness 2. Enrolled in other epilepsy-related non-pharmacological treatment studies

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026