title: Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  http://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).
authors.affiliation: Centre for Lifespan and Chronic Illness Research, Department of Psychology, School of Life and Medical Sciences, University of Hertfordshire, College Lane Campus, Hatfield AL10 9AB, UK. m.durand@herts.ac.uk.
authors.forename: Marie-Anne
authors.initials: MA
authors.lastname: Durand
authors.forename: Bob
authors.initials: B
authors.lastname: Gates
authors.forename: Georgina
authors.initials: G
authors.lastname: Parkes
authors.forename: Asif
authors.initials: A
authors.lastname: Zia
authors.forename: Karin
authors.initials: K
authors.lastname: Friedli
authors.forename: Garry
authors.initials: G
authors.lastname: Barton
authors.forename: Howard
authors.initials: H
authors.lastname: Ring
authors.forename: Linda
authors.initials: L
authors.lastname: Oostendorp
authors.forename: David
authors.initials: D
authors.lastname: Wellsted
mesh_terms: D000223:Adaptation, Psychological; D000328:Adult; D002985:Clinical Protocols; D032882:Comprehension; D017281:Cost of Illness; D004739:England; D004827:Epilepsy / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006801:Humans; D007859:Learning Disabilities / Q000175:diagnosis / Q000523:psychology / Q000534:rehabilitation*; D008297:Male; D010174:Pamphlets; D010353:Patient Education as Topic / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome