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BMJ Open. 2016 Nov 10;6(11):e012993. doi: 10.1136/bmjopen-2016-012993.

Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial.

Author information

1
Department of Psychology, Centre for Health Services and Clinical Research, University of Hertfordshire, Hatfield, UK.
2
Institute for Practice, Interdisciplinary Research and Enterprise (INSPIRE), University of West London, London, UK.
3
Learning Disabilities Services, Hertfordshire Partnership University NHS Foundation Trust, St Albans, UK.
4
Norwich Medical School and Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.
5
Department of Psychiatry, University of Cambridge, School of Clinical Medicine, Cambridge, UK.
6
Research and Development, Hertfordshire Partnership University NHS Foundation Trust, St Albans, UK.
7
Division 4, Mental Health, NIHR Clinical Research Network: Eastern, UK.
8
Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, UK.
9
The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Hanover, New Hampshire, USA.

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 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.

KEYWORDS:

MENTAL HEALTH; PSYCHIATRY

PMID:
28186943
PMCID:
PMC5128894
DOI:
10.1136/bmjopen-2016-012993
[Indexed for MEDLINE]
Free PMC Article

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