Condition category
Nervous System Diseases
Date applied
23/04/2014
Date assigned
23/04/2014
Last edited
17/12/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Condition

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

Intervention

Books Beyond Word: 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 measures

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

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

Sponsor information

Organisation

Hertfordshire Partnership Foundation NHS Trust (UK)

Sponsor details

99 Waverley Road
St. Albans
AL3 5TL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25414095

Publication citations

Additional files

Editorial Notes