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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN13871327
Date of registration: 23/04/2015
Prospective Registration: Yes
Primary sponsor: University of Liverpool
Public title: Seizure first Aid training For Epilepsy: intervention development and pilot RCT
Scientific title: ‘Seizure first Aid training For Epilepsy’ (SAFE) for people with epilepsy who attend emergency departments, and their family and friends: intervention development and pilot.
Date of first enrolment: 01/06/2015
Target sample size: 207
Recruitment status: Ongoing
URL:  http://isrctn.com/ISRCTN13871327
Study type:  Interventional
Study design:  Randomised; Interventional and Observational; Design type: Treatment, Qualitative (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Name: Adam  Noble
Address:  University of Liverpool Institute of Psychology, Health & Society, The Whelan Building L69 3GL Liverpool United Kingdom
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion 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: 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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Epilepsy
Nervous System Diseases
Intervention(s)
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-hour course (with breaks included) run by locally based Epilepsy Society trained educational facilitators. Participants will receive the course in addition to their usual care.
2. Treatment as Usual: The active intervention will be compared to TAU alone. The appropriate control comparison for the study will be TAU by the PWE’s normal care team.

All control participants will be offered access to the 'Seizure first Aid training For Epilepsy' programme once the study has finished. These courses will be run once all retained patient and carer participants from both arms have completed their 12 month follow up assessments.
Follow Up Length: 12 month(s); Study Entry : Single Randomisation only
Primary Outcome(s)
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.
Secondary Outcome(s)
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.
Secondary ID(s)
18717
Source(s) of Monetary Support
National Institute for Health Research
Secondary Sponsor(s)
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