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

Not Applicable

Completed

• Conditions: Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Epilepsy; Nervous System Diseases

• Registration Number: ISRCTN13871327
• Lead Sponsor: niversity of Liverpool

Brief Summary

2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26209121 protocol 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28213317 results 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33112533/ (added 19/05/2023) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32303515/ (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-23
• Study Completion: 2016-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified