Influence on quality of life of various treatment choices of people with drug-resistant epilepsy
| ISRCTN | ISRCTN56117572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56117572 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 272686 |
| Protocol serial number | Version 2.0, IRAS 272686 |
| Sponsor | Cornwall Partnership NHS Foundation Trust |
| Funder | Liva Nova USA Inc. |
- 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
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
Public
The Kernow Building
Wilson Way
Pool
Pool
TR15 3QE
United Kingdom
 ORCID ID |
0000-0001-9033-6752 |
|---|---|
| Phone | +44 (0)1209 204020 |
| sarah.lennard@nhs.net |
Scientific
Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
| ORCID ID |
0000-0002-1183-6933 |
|---|---|
| Phone | +44 (0)1208 834455 |
| rohit.shankar@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Pharmacoresistant epilepsy treatment options & quality of life V1 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) | Quality of life measured using QOLIE-31 at baseline then quarterly for 1 year |
| Key secondary outcome measure(s) | There are no secondary outcome measures |
| Completion date | 01/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | Diagnosis of epilepsy |
| Key exclusion criteria | Unable to give consent |
| Date of first enrolment | 31/10/2021 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
Combe Park
Bath
BA1 3NG
United Kingdom
London
NW3 2QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
