Mengoni, Silvana E., Gates, Bob, Parkes, Georgina, Wellsted, David, Barton, Garry, Ring, Howard, Khoo, Mary Ellen, Monji-Patel, Deela, Friedli, Karin, Zia, Asif, Irvine, Lisa and Durand, Marie-Anne (2016) Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial. BMJ Open, 6 (11). e012993. ISSN 2044-6055
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feasibility RCT paper_BMJOpen revised 29.07.16.docx - Accepted Version
Objective: To investigate the feasibility of a full-scale randomized controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities.
Trial design: A randomized 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 one English NHS Trust.
Participants: Patients with learning disabilities and epilepsy who had: a seizure within the last 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. The control group received treatment as usual, and were provided with a booklet at the end of the study.
Outcomes: Seven feasibility criteria were used relating to recruitment, attrition, data collection, potential effect on epilepsy-related quality of life (ELDQOL) at 4, 12, and 20-week follow-ups, potential to calculate cost-effectiveness, feasibility of methodology and acceptability of the intervention.
Outcome: The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition, and a positive indication of the potential for a cost-effectiveness analysis. The booklet and study methods were positively received. 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. No adverse events were reported.
Conclusions: All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial.
|Additional Information:||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/|
|Subjects:||Medicine and health > Nursing|
|Depositing User:||Bob Gates|
|Date Deposited:||28 Oct 2016 13:11|
|Last Modified:||15 Mar 2017 15:05|
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