Contact information
Type
Scientific
Primary contact
Dr Marie-Anne Durand
ORCID ID
Contact details
College Lane
Hatfield
AL10 9AB
United Kingdom
-
m.durand@herts.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16588
Study information
Scientific title
A randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities
Acronym
Wordless Intervention for Epilepsy in Learning Disabilities (WIELD)
Study hypothesis
Epilepsy is the most common health problem that affects people with learning disabilities. It is more complex, more severe, and leads to more deaths in people with learning disabilities than in the general population who live with epilepsy. People with epilepsy and learning disabilities find it difficult to manage their illness. They do not have easy access to services and struggle to manage repeated seizures. They are often resistant to treatment, which can lead to premature deaths and increased costs. The guidelines of the National Institute for Health and Care Excellence recommend that patients with learning disabilities and epilepsy are offered the same standard of care, services and investigations as the general population.
The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities better understand and manage their condition and improve their quality of life. This intervention has never been formally evaluated and its effectiveness remains unknown. Given the lack of research in this area, it is recommended that this intervention is evaluated in a feasibility trial. This will determine whether a larger trial can be undertaken and what sample size, design and methods are most appropriate. The acceptability, potential effectiveness and cost effectiveness of using the booklet for epilepsy will also be explored. Eligible patients with epilepsy and learning disabilities will be randomised to receive either the Books Beyond Words booklet for epilepsy or routine information and care. In the intervention group, the booklet will be used at the Epilepsy Clinic with a Research Nurse and Carer, and later at home with the carer or family. Outcomes will be measured at 1, 3 and 5 months. Semi-structured interviews will also be used to assess the feasibility and acceptability.
Ethics approval
MREC;17/04/2014; ref. 14/WA/0135
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Mental Health, Neurological disorders; Subtopic: Learning difficulties development disorders,
Neurological (all Subtopics); Disease: Learning difficulties, Epilepsy
Intervention
The Books Beyond Words booklet: Getting on with Epilepsy, uses pictures to tell a story about a young man with learning disabilities and epilepsy who progressively learns how to better manage epilepsy and recurrent seizures. All images have been tested with people with mild and severe learning disabilities to ensure understanding. The intervention aims to improve seizure control, reduce the risk of falls and seizure-related injuries, and improve quality of life. It also aims to illustrate best
Follow Up Length: 5 month(s); Study Entry : Single Randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Quality of life [Epilepsy and Learning Disabilities Quality of Life (ELDQOL) scale]; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)
Secondary outcome measures
1. Demographic data; Timepoint(s): Baseline (T0)
2. Discontinuation rates; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)
3. EQ-5D; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)
4. Feasibility and acceptability of study procedures and intervention; Timepoint(s): week 20 (T3)
5. Intervention's patterns of use; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)
6. Rates of recruitment; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)
7. Resource use; Timepoint(s): Baseline (T0), week 20 (T3)
8. Seizure control; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)
9. Seizure severity; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)
Overall trial start date
01/07/2014
Overall trial end date
29/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female patients, over 18 years of age
2. A confirmed clinical diagnosis of epilepsy (according to medical notes) and at least one seizure over the past 12 months
3. A confirmed clinical diagnosis of a learning disability (significantly below-average general intellectual functioning and an IQ below or equal to 70)
4. Ability to communicate verbally. The patient has a vocabulary of more than 10 words and can use 1 to 2 words, or more, to communicate
5. The carer is sufficiently proficient in English to read and complete the questionnaires with the patient
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 40; UK Sample Size: 40
Participant exclusion criteria
1. Vision impairment
2. Confirmed diagnosis of dementia
3. Has used the Books Beyond Words booklet for epilepsy in the past 12 months
Recruitment start date
01/07/2014
Recruitment end date
29/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
College Lane
Hatfield
AL10 9AB
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB); Ref.: PB-PG-0213-30042
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25414095
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/28186943