Influence on quality of life of various treatment choices of people with drug-resistant epilepsy

ISRCTN ISRCTN56117572
DOI https://doi.org/10.1186/ISRCTN56117572
IRAS number 272686
Secondary identifying numbers Version 2.0, IRAS 272686
Submission date
14/08/2020
Registration date
26/08/2020
Last edited
19/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 2024

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

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

Contact information

Mrs Sarah Lennard
Public

The Kernow Building
Wilson Way
Pool
Pool
TR15 3QE
United Kingdom

ORCiD logoORCID ID 0000-0001-9033-6752
Phone +44 (0)1209 204020
Email sarah.lennard@nhs.net
Dr Rohit Shankar
Scientific

Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom

ORCiD logoORCID ID 0000-0002-1183-6933
Phone +44 (0)1208 834455
Email rohit.shankar@nhs.net

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet No participant information sheet available
Scientific titlePharmacoresistant epilepsy treatment options & quality of life V1
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedPharmacoresistant epilepsy in adults
InterventionStage 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 typeMixed
Primary outcome measureQuality of life measured using QOLIE-31 at baseline then quarterly for 1 year
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/01/2019
Completion date01/09/2024

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants150
Key inclusion criteriaDiagnosis of epilepsy
Key exclusion criteriaUnable to give consent
Date of first enrolment31/10/2021
Date of final enrolment30/06/2023

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Cornwall Partnership NHS Foundation Trust
Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
Royal United Hospitals Bath
Royal Bath Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
Royal Free London
Pond Street
London
NW3 2QG
United Kingdom

Sponsor information

Cornwall Partnership NHS Foundation Trust
Hospital/treatment centre

The Kernow Building
Wilson Way
Pool
Redruth
TR15 3QE
England
United Kingdom

Phone +44 (0)1209 204020
Email cpn-tr.cftresearch@nhs.net
Website https://www.cornwallft.nhs.uk/
ROR logo "ROR" https://ror.org/0517ad239

Funders

Funder type

Industry

Liva Nova USA Inc.

No information available

Results and Publications

Intention to publish date01/04/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planCurrent publication and dissemination plan as of 18/06/2021:
1. Planned publication of the protocol
2. Initial publication following audit due for publication by the end of 2020
3. Final results publication


Previous 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 planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

19/10/2022: The recruitment end date has been changed from 31/10/2022 to 30/06/2023.
26/08/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2020 to 31/10/2021.
2. The recruitment end date has been changed from 30/04/2022 to 31/10/2022.
3. The overall trial end date has been changed from 01/09/2022 to 01/09/2024 and the plain English summary has been updated to reflect this change.
18/06/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/09/2021 to 30/04/2022.
2. The trial participating centres "Royal United Hospitals Bath" and "Royal Free London" have been added.
3. The intention to publish date has been changed from 31/12/2020 to 01/04/2024.
4. The publication and dissemination plan has been updated.
25/08/2020: Trial's existence confirmed by London - Camberwell St Giles Research Ethics Committee.