title: Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial.
abstract: To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities.
  
  
  
  A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio.
  
  
  
  Epilepsy clinics in 1 English National Health Service (NHS) Trust.
  
  
  
  Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English.
  
  
  
  Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study.
  
  
  
  7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness.
  
  
  
  The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis.
  
  
  
  All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.
  
  
  
  ISRCTN80067039.
authors.affiliation: Department of Psychology, Centre for Health Services and Clinical Research, University of Hertfordshire, Hatfield, UK.
authors.forename: Silvana E
authors.initials: SE
authors.lastname: Mengoni
authors.affiliation: Institute for Practice, Interdisciplinary Research and Enterprise (INSPIRE), University of West London, London, UK.
authors.forename: Bob
authors.initials: B
authors.lastname: Gates
authors.affiliation: Learning Disabilities Services, Hertfordshire Partnership University NHS Foundation Trust, St Albans, UK.
authors.forename: Georgina
authors.initials: G
authors.lastname: Parkes
authors.affiliation: Department of Psychology, Centre for Health Services and Clinical Research, University of Hertfordshire, Hatfield, UK.
authors.forename: David
authors.initials: D
authors.lastname: Wellsted
authors.affiliation: Norwich Medical School and Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
authors.forename: Garry
authors.initials: G
authors.lastname: Barton
authors.affiliation: Department of Psychiatry, University of Cambridge, School of Clinical Medicine, Cambridge, UK.
authors.forename: Howard
authors.initials: H
authors.lastname: Ring
authors.affiliation: Research and Development, Hertfordshire Partnership University NHS Foundation Trust, St Albans, UK.
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: Khoo
authors.affiliation: Research and Development, Hertfordshire Partnership University NHS Foundation Trust, St Albans, UK.|Division 4, Mental Health, NIHR Clinical Research Network: Eastern, UK.
authors.forename: Deela
authors.initials: D
authors.lastname: Monji-Patel
authors.affiliation: Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, UK.
authors.forename: Karin
authors.initials: K
authors.lastname: Friedli
authors.affiliation: Learning Disabilities Services, Hertfordshire Partnership University NHS Foundation Trust, St Albans, UK.
authors.forename: Asif
authors.initials: A
authors.lastname: Zia
authors.affiliation: Norwich Medical School and Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Irvine
authors.affiliation: Department of Psychology, Centre for Health Services and Clinical Research, University of Hertfordshire, Hatfield, UK.|The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Hanover, New Hampshire, USA.
authors.forename: Marie-Anne
authors.initials: MA
authors.lastname: Durand
mesh_terms: D000328:Adult; D003362:Cost-Benefit Analysis; D004827:Epilepsy / Q000150:complications*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007859:Learning Disabilities / Q000150:complications* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010174:Pamphlets; D010353:Patient Education as Topic; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
keywords: MENTAL HEALTH; PSYCHIATRY