Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2014 Nov 20:15:455.
doi: 10.1186/1745-6215-15-455.

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial

Marie-Anne Durand  1 , Bob Gates, Georgina Parkes, Asif Zia, Karin Friedli, Garry Barton, Howard Ring, Linda Oostendorp, David Wellsted
Affiliations
Randomized Controlled Trial

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial

Marie-Anne Durand et al. Trials. .

Abstract

Background: Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy.

Methods/design: We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014.

Discussion: The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities.

Trial registration: http://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

PubMed Disclaimer

Figures

Figure 1
Figure 1
The Books Beyond Words intervention.
Figure 2
Figure 2
Consolidated Standards of Reporting Trials (CONSORT) study flow-chart.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Mariani E, Ferini-Strambi L, Sala M, Erminio C, Smirne S. Epilepsy in institutionalized patients with encephalopathy: clinical aspects and nosological considerations. Am J Ment Retard. 1993;98(Suppl):27–33. - PubMed
    1. Van Schrojenstein Lantman De Valk HM, Metsemakers JF, Haveman MJ, Crebolder HF. Health problems in people with intellectual disability in general practice: a comparative study. Fam Pract. 2000;17:405–407. doi: 10.1093/fampra/17.5.405. - DOI - PubMed
    1. Van Schrojenstein Lantman De Valk HM, Van Den Akker M, Maaskant MA, Haveman MJ, Urlings HF, Kessels AG, Crebolder HF. Prevalence and incidence of health problems in people with intellectual disability. J Intellect Disabil Res. 1997;41:42–51. doi: 10.1111/j.1365-2788.1997.tb00675.x. - DOI - PubMed
    1. Van Schrojenstein Lantman De Valk HM, Walsh PN. Managing health problems in people with intellectual disabilities. BMJ. 2008;337:a2507. doi: 10.1136/bmj.a2507. - DOI - PubMed
    1. Bowley C, Kerr M. Epilepsy and intellectual disability. J Intellect Disabil Res. 2000;44:529–543. doi: 10.1046/j.1365-2788.2000.00270.x. - DOI - PubMed

Publication types

MeSH terms

Associated data