A randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities

ISRCTN ISRCTN80067039
DOI https://doi.org/10.1186/ISRCTN80067039
Protocol serial number 16588
Sponsor Hertfordshire Partnership Foundation NHS Trust (UK)
Funder National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB); Ref.: PB-PG-0213-30042
Submission date
23/04/2014
Registration date
23/04/2014
Last edited
16/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marie-Anne Durand
Scientific

College Lane
Hatfield
AL10 9AB
United Kingdom

m.durand@herts.ac.uk

Study information

Primary study designInterventional
Study designRandomised; Interventional; Design type: Treatment
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities
Study acronymWordless Intervention for Epilepsy in Learning Disabilities (WIELD)
Study objectivesEpilepsy 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(s)MREC;17/04/2014; ref. 14/WA/0135
Health condition(s) or problem(s) studiedManaging epilepsy in people with learning disabilities
InterventionThe 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 typeOther
Primary outcome measure(s)

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)

Key secondary outcome measure(s)

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)

Completion date29/02/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration40
Key inclusion criteria1. 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
Key exclusion criteria1. Vision impairment
2. Confirmed diagnosis of dementia
3. Has used the Books Beyond Words booklet for epilepsy in the past 12 months
Date of first enrolment01/07/2014
Date of final enrolment29/02/2016

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

College Lane
Hatfield
AL10 9AB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/11/2016 Yes No
Protocol article protocol 20/11/2014 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

16/03/2020: Internal review.
13/02/2017: Publication reference added.

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