Condition category
Nervous System Diseases
Date applied
14/08/2020
Date assigned
26/08/2020
Last edited
25/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Epilepsy is a condition that affects the brain and causes seizures. Epilepsy surgery is recommended for people with epilepsy (PWE) whose seizures cannot be managed by antiepileptic drugs (AEDs). The aim of this study is to examine how different groups of PWE drawn from the same group of repeat emergency department (ED) attenders fare when the NICE Guideline care pathways for people with epilepsy is applied to them. PWE will be in one of four groups:
1. Those who follow the surgical pathway, including vagus nerve stimulation (VNS) treatment
2. Those who have a change of medication to 3rd generation antiepileptic medication
3. Those who have no change initially but are followed up in specialist care
4. Those who do not engage with specialist services offered
The researchers propose to look at people’s quality of life in each group, including a quarterly review of medical records looking at changes to seizure frequency and type, ED attendance, tolerance, compliance and use of rescue medications.

Who can participate?
Patients aged over 18 who have attended the Royal Cornwall Hospital (Treliske) ED at least twice between 2018-2018 and have not been seen since 01/01/2019 by an epilepsy specialist

What does the study involve?
Participants complete a set of questionnaires including a quality of life questionnaire and the Connect Epilepsy tool. This will be completed at the start of the study and quarterly for 1 year after. Each participant's medical records will be accessed for ED attendance, use of rescue medications, paramedic attendance, and side effects. Each group will be offered treatments as per routine clinical practice and choice:
Group 1: PWE eligible for surgery: This group will be referred to a tertiary centre (Bristol) for suitable assessment and surgery. PWE may receive 3rd generation AEDs while their decision for surgery awaits confirmation.
Group 2: PWE either is ineligible for surgery or choose not to be referred for one. PWE undergo a second assessment for most beneficial AED. They might receive 3rd Generation AEDs.
Group 3: PWE refuses surgery and/or change in medication. This group's treatment plan does not change but continue to see epilepsy specialists.
Group 4: PWE who do receive treatment change and are unwilling to engage with specialist services. However, patient admissions to ED will be recorded.
Each group's medical records will be reviewed on a quarterly basis for the above-described data for 1 year and exit interviews are conducted.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement in their quality of life.

Where is the study run from?
Royal Cornwall Hospital (Treliske) and Cornwall Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2019 to September 2022

Who is funding the study?
Liva Nova Inc. (USA)

Who is the main contact?
Sarah Lennard
sarah.lennard@nhs.net

Trial website

Contact information

Type

Public

Primary contact

Mrs Sarah Lennard

ORCID ID

http://orcid.org/0000-0001-9033-6752

Contact details

The Kernow Building
Wilson Way
Pool
Pool
TR15 3QE
United Kingdom
+44 (0)1209 204020
sarah.lennard@nhs.net

Type

Scientific

Additional contact

Dr Rohit Shankar

ORCID ID

http://orcid.org/0000-0002-1183-6933

Contact details

Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
+44 (0)1208 834455
rohit.shankar@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Version 2.0, IRAS 272686

Study information

Scientific title

Pharmacoresistant epilepsy treatment options & quality of life V1

Acronym

Study hypothesis

The aim of the study is to examine how different groups of PWE drawn from the same cohort of being repeat ED attenders fare when the NICE Guideline care pathways for people with epilepsy is applied to them. PWE will be in one of four groups:
1. Those who follow the surgical pathway, including VNS
2. Those that have a change of medication to 3rd generation antiepileptic medication
3. Those that have no change initially but are followed up in specialist care
4. Those that do not engage with specialist services offered

The researchers propose to look at people’s quality of life in each group, including a quarterly review of medical records looking at changes to seizure frequency and type, ED attendance, tolerance, compliance and use of rescue medications.

Ethics approval

Approved 11/06/2020, London - Camberwell St Giles Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)2071048103; camberwellstgiles.rec@hra.nhs.uk), REC ref: 20/LO/0700

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Pharmacoresistant epilepsy in adults

Intervention

Stage 1: Treatment Plan
An epilepsy specialist will review an identified cohort of PWE (serial no-attenders to ED). Reviewed PWE will be divided into four groups depending on the assessor's recommendations and PWE engagement and treatment choice.

Stage 2: Pre-Treatment Questionnaire
All consenting PWE will complete a set of questionnaires before beginning their treatment and at their reviews. Information on side effects, medication effectiveness, compliance, Emergencies (ED, paramedic attendance, rescue medication), risk assessments (Sudden Unexpected Death in Epilepsy (SUDEP) & Seizure Safety Checklist) and quality of Life (QOL) scales (QOLIE-31 and Connect Epilepsy tool)

Step 3: Treatments
Each group will be offered treatments as per routine clinical practice and choice:
Group 1: PWE eligible for surgery: This group will be referred to a tertiary centre (Bristol) for suitable assessment and surgery. PWE may receive 3rd generation AEDs while their decision for surgery awaits confirmation.
Group 2: PWE either is ineligible for surgery or choose not to be referred for one. PWE undergo a second assessment for most beneficial AED. They might receive 3rd Generation AEDs.
Group 3: PWE refuses surgery and/or change in medication. This group's treatment plan does not change but continue to see epilepsy specialists.
Group 4: PWE who do receive treatment change and are unwilling to engage with specialist services. However, patient admissions to ED will be recorded.

Step 4: Follow Up
Each group's medical records will be reviewed on a quarterly basis for the above-described data collection for 1 year, QOL questionnaires will also be completed quarterly for 1 year together with exit interviews for QOL scales conducted for those in groups 1-3.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Quality of life measured using QOLIE-31 at baseline then quarterly for 1 year

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/01/2019

Overall trial end date

01/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Diagnosis of epilepsy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Unable to give consent

Recruitment start date

01/09/2020

Recruitment end date

01/09/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cornwall Partnership NHS Foundation Trust
Carew House Beacon Technology Park Dunmere Road
Bodmin
PL31 2QN
United Kingdom

Sponsor information

Organisation

Cornwall Partnership NHS Foundation Trust

Sponsor details

The Kernow Building
Wilson Way
Pool
Redruth
TR15 3QE
United Kingdom
+44 (0)1209 204020
cpn-tr.cftresearch@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.cornwallft.nhs.uk/

Funders

Funder type

Industry

Funder name

Liva Nova USA Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication of the protocol
2. Initial publication following audit due for publication by the end of 2020

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/08/2020: Trial's existence confirmed by London - Camberwell St Giles Research Ethics Committee.