作者: Silvana E Mengoni , Bob Gates , Georgina Parkes , David Wellsted , Garry Barton
DOI: 10.1136/BMJOPEN-2016-012993
关键词:
摘要: Objective To investigate the feasibility of a full-scale randomised controlled trial picture booklet to improve quality life for people with epilepsy and learning disabilities. Trial design A trial. Randomisation was not blinded conducted using centralised secure database blocked 1:1 allocation ratio. Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust. Participants Patients disabilities who had: seizure within past 12 months, meaningful communication carer sufficient proficiency English. Intervention intervention group used trained researcher, present. These participants kept booklet, were asked use it at least twice more over 20 weeks. The control received treatment as usual, provided end study. Outcome measures 7 criteria relating recruitment, data collection, attrition, potential effect on epilepsy-related (Epilepsy Learning Disabilities Quality Life Scale, ELDQOL) 4-week, 12-week 20-week follow-ups, methodology, acceptability calculate cost-effectiveness. recruitment rate eligible patients 34% target 40 reached. There minimal missing attrition. An intention-to-treat analysis performed; from outcome suggest benefit ELDQOL behaviour mood subscales 4 20 weeks follow-up. study methods positively received, no adverse events reported. positive indication cost-effectiveness analysis. Conclusions All fully or partially met, therefore confirming definitive registration number ISRCTN80067039.