Title: A randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities
Funder: Department of Health (England)

Abstract: People with learning disabilities suffer from health inequalities that are, to some extent, avoidable, and are often unrecognised. They have more health problems, and are at higher risk of premature death than the general population 5. Epilepsy is the most common neurological disorder affecting people with learning disabilities, and is 20 times more common than in the general population 6 7. The high incidence (16 to 26%), high seizure frequency, resistance to treatments, and associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities 8-10. It is therefore associated with more premature deaths and higher costs in patients with learning disabilities than in the general population of people living with epilepsy 2-4. The National Institute for Health and Care Excellence and the Royal College of General Practitioners advocate for the recognition of the needs of people with learning disabilities and epilepsy, mostly unmet, so they can be informed and empowered to manage their condition adequately. Interventions that target the needs of patients with learning disabilities, their carers, and health providers could improve communication, access to services, knowledge and quality of life, therefore contributing to reduce health disparities 1 11. The Books Beyond Words booklet for epilepsy uses images that tell the story of a young man with learning disabilities and epilepsy, in order to improve understanding, illness management and quality of life of people with learning disabilities. All images have been tested with people with mild to severe learning disabilities who cannot read, to make sure they understand them. The Books Beyond Words booklet was developed jointly by the Royal College of Psychiatrists and Books Beyond Words, with the involvement of people with learning disabilities, their carers, consultant psychiatrists and other medical professionals 12. To date, this booklet has never been evaluated in controlled contexts or routinely adopted in the NHS. Our aim is to undertake a randomised controlled feasibility trial of the Books Beyond Words booklet for epilepsy with qualitative research, testing the feasibility of a large-scale randomised controlled trial in patients with learning disabilities. The following research questions will guide the study design, methods of data collection and analysis: - What is the feasibility of undertaking a full-scale randomised controlled trial of the Books Beyond Words intervention for epilepsy in people with learning disabilities? - Is this intervention acceptable to patients with learning disabilities, carers and health professionals? - What is the potential effectiveness and cost effectiveness of this intervention? Patients with learning disabilities who meet the study’s inclusion criteria will be recruited from 5 epilepsy clinics and randomised to either the intervention or control arm of the project. Consent will be obtained with the carer’s involvement, who will assess participants’ capacity to take part, as specified in the Mental Capacity Act. A Research Nurse will manage the information, consent and baseline assessment. Outcomes will be assessed at one month, three months, and five months post-randomisation. The use and acceptability of the intervention will be assessed using semi-structured interviews conducted with patients, carers and health professionals (see study flow diagram in Appendix 4). Although this feasibility study is not powered to assess the effectiveness and cost effectiveness of the intervention, we will undertake a preliminary analysis of both the potential effectiveness and cost-effectiveness of the intervention, which will provide necessary information to design and power a full-scale trial. The information gained from this feasibility trial will then be used to solicit funding for a full-scale trial of the Books Beyond Words booklet for epilepsy.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH;NEUROLOGICAL