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

Abstract

BackgroundEpilepsy 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/DesignWe 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.DiscussionThe 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 registrationhttp://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

Self-management interventions for epilepsy in people with intellectual disabilities: A scoping review

“…Durand et al evaluated an intervention among 40 adults with ID and epilepsy as part of a randomised controlled feasibility study [27,32]. Ring et al are currently investigating the efficacy of a nurseled management intervention among 312 adults with ID and epilepsy [28][personal communication].…”

“…Two studies randomized patients to a control or intervention arm [27,28]. All five studies were conducted between 2001 and 2016 in the United Kingdom.…”

“…All studies administered questionnaires pre and post intervention, with three studies conducting follow-up assessments [27][28][29]. Three studies A c c e p t e d M a n u s c r i p t 8 assessed epilepsy knowledge [29,30,31].…”

“…All five studies assessed outcomes through questionnaires and two studies also conducted semi-structured interviews [27,28]. All studies administered questionnaires pre and post intervention, with three studies conducting follow-up assessments [27][28][29].…”

“…<Insert Table 2 Here> Study designs included: a feasibility RCT [27], a cluster RCT currently underway [28], a deferred entry to treatment design [29], a repeated measure design [30], and user testing with the specific study design not indicated [31]. Two studies randomized patients to a control or intervention arm [27,28].…”