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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 
ORCID: https://orcid.org/0000-0003-1936-3584 and Durand, Marie Anne
(2016)
Wordless intervention for people with epilepsy and learning disabilities (WIELD):A randomised controlled feasibility trial.
BMJ Open, 6 (11).
ISSN 2044-6055
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Abstract
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 costeffectiveness. 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.
| Item Type: | Article |
|---|---|
| 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/ |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Health Economics Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research |
| Related URLs: | |
| Depositing User: | Pure Connector |
| Date Deposited: | 07 Dec 2016 00:06 |
| Last Modified: | 02 Mar 2023 02:05 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/61599 |
| DOI: | 10.1136/bmjopen-2016-012993 |
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