Objective 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.
Trial design A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio.
Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust.
Participants 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.
Intervention 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.
Outcome measures 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.
Outcome 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.
Conclusions All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.
Trial registration number ISRCTN80067039.
- MENTAL HEALTH
This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Statistics from Altmetric.com
Contributors M-AD, BG, GP, AZ, KF, GB, HR and DW participated in the design and conception of the study. MEK, DM-P, SEM, GP and AZ recruited participants. SEM, MEK and DM-P collected data. SEM, DW, M-AD, LI and GB analysed data. SEM drafted the article, which was revised by M-AD. All authors commented on all subsequent drafts. All authors read and approved the final version of the manuscript.
Funding This manuscript presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (grant reference number PB-PG-0213-30042).
Competing interests None declared.
Ethics approval This study was approved by NRES Wales Research Ethics Committee 5 in April 2014 (Ref: 14/WA/0135).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All requests should be directed to the corresponding author.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.