Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Marie-Anne Durand


Contact details

College Lane
AL10 9AB
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Topic: Mental Health, Neurological disorders; Subtopic: Learning difficulties development disorders,
Neurological (all Subtopics); Disease: Learning difficulties, Epilepsy


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

College Lane
AL10 9AB
United Kingdom

Sponsor information


Hertfordshire Partnership Foundation NHS Trust (UK)

Sponsor details

99 Waverley Road
St. Albans
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


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


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:
2016 results in:

Publication citations

Additional files

Editorial Notes

13/02/2017: Publication reference added.