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  • Study protocol
  • Open Access
  • Open Peer Review

Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial

  • 1, 2Email author,
  • 3,
  • 4,
  • 4,
  • 1,
  • 5,
  • 6,
  • 1 and
  • 1
Trials201415:455

https://doi.org/10.1186/1745-6215-15-455

  • Received: 2 June 2014
  • Accepted: 31 October 2014
  • Published:
Open Peer Review reports

Abstract

Background

Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy.

Methods/Design

We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention’s patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014.

Discussion

The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities.

Trial registration

http://ISRCTN80067039 (Date of ISRCTN assignation: 23 April 2014).

Keywords

  • Epilepsy
  • Learning disability
  • Intervention
  • Feasibility trial
  • Clinical protocol

Background

Rationale

People with learning disabilities experience a disproportionate burden of ill health and are affected by twice the number of health issues prevailing in the general population: higher incidence of long-term conditions and health risks, poorer health outcomes and an increased risk of premature death [14]. Epilepsy is one of many long-term conditions affecting people with learning disabilities that burdens their lives and hinders their quality of life [5]. It is considered the most common neurological disorder in people with learning disabilities, with a reported prevalence of 16 to 44% [2, 58], compared to 0.4% to 1% in the general population [9, 10].

The clinical management of epilepsy in people with learning disabilities is complex, due to both the clinical characteristics of the condition, as well as physical and cognitive impairments affecting them. Seizures are frequent, atypical and often severe. Approximately 70% of all seizures are refractory to treatment [1114]. Seizures are less well controlled than in the general population of people with epilepsy, and may be accompanied by co-morbid health, mental health, sensory-motor and communication issues [1517]. Poorly controlled epilepsy can severely affect social relationships, work, daily activities, quality of life and mortality [1820]. As a result, young people and adults with learning disabilities and epilepsy face higher risks of premature and avoidable death related to epilepsy than the general population [21]. In addition, research shows that poorly controlled seizures and seizure frequency are associated with increased costs [22]. Pennington et al. recently demonstrated increased costs in people with epilepsy and learning disabilities [23], with a total estimated cost per patient, per annum, of £64,000 (including accommodation and basic care).

Managing long-term conditions is challenging for all patients, irrespective of their abilities and co-morbidities. However, it is even more complex for those with learning disabilities, who may not have the knowledge, skills and support required to assess potential risks and cope with recurring seizures, prescribed medications and regular doctor appointments. Research suggests that access to specialist services is poor for people with epilepsy and learning disabilities [24]. For carers and families who are not trained in supporting self-management, caring for adults with ‘dual disabilities’ can be extremely challenging and increase the caregiver burden [5]. Despite its high incidence, little is known about the management of epilepsy in people with learning disabilities, and those who support them. Research suggests that people with learning disabilities and epilepsy lack skills training adapted to their needs and intellectual abilities, and often fail to adequately manage and control their epilepsy [20]. The standard of care offered to people with learning disabilities and epilepsy is significantly poorer than in the general population, as is the case for most disease areas affecting people with learning disabilities [24, 25].

Guidelines from the National Institute for Health and Care Excellence (NICE) state that patients with epilepsy and learning disabilities: ‘should be empowered to manage their condition as well as possible, and should receive appropriate information and education about all aspects of epilepsy […] accessible to people with additional needs such as physical, sensory or learning disabilities’ [26]; p.9.

The Books Beyond Words booklet Getting on with Epilepsy has been designed to help people with learning disabilities and epilepsy understand and manage their illness through images that have been tested with people with mild to severe learning disabilities. The intervention is based on the assumption that people with learning disabilities who cannot read and have limited communication abilities are visually literate. Although the success and impact of the Books Beyond Words booklets (over 30 available) have been recognized by several awards and collaborations with established patient organizations, they have not as yet been formally evaluated in controlled settings or routinely adopted in the United Kingdom National Health Service (NHS). The lack of conclusive data on the effectiveness of educational interventions for people with epilepsy and learning disabilities warrants further investigation [24, 26].

Aim

We aim to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet as an intervention for epilepsy in adults with learning disabilities.

Objectives

Our objectives are to:
  1. 1.

    Assess the feasibility of undertaking a randomized controlled trial of the Books Beyond Words intervention for epilepsy in people with learning disabilities.

     
  2. 2.

    To explore the feasibility of collecting resource use and quality of life data so as to inform the design of the health economics component of a future definitive trial.

     
  3. 3.

    Assess the study procedures’ and intervention’s acceptability among adults with learning disabilities, carers and health professionals.

     

Methods/Design

Study design and setting

We will use a two-arm, single-centre design and will conduct the study over a 20-month period at Hertfordshire Partnership University NHS Foundation Trust, United Kingdom. The trust runs five epilepsy clinics, managing 196 adults with learning disabilities and epilepsy. The patients are seen on average once a month. We will randomly allocate eligible participants to an intervention arm (provision of the Books Beyond Words booklet Getting on with Epilepsy) and control arm (routine information and services), and will recruit participants over six months.

Participants

Eligible participants will be identified by the consultant psychiatrists who run the epilepsy clinics. Each psychiatrist will compile a log of potentially eligible patients from existing records and from new referrals using the following criteria.

Inclusion criteria

The inclusion criteria for this study are as follows:
  1. 1.

    Male and female patients, over 18 years of age.

     
  2. 2.

    A confirmed clinical diagnosis of epilepsy (according to medical notes) and at least one seizure over the past 12 months.

     
  3. 3.

    A confirmed clinical diagnosis of a learning disability (significantly below-average general intellectual functioning, and an IQ below or equal to 70).

     
  4. 4.

    Meaningful communication that enables the patient to tell or follow the Books Beyond Words story, as judged by the carer and/or health professional.

     
  5. 5.

    The carer is sufficiently proficient in English to read and complete the questionnaires with the patient.

     

Exclusion criteria

The exclusion criteria for this study are as follows:
  1. 1.

    Vision impairment.

     
  2. 2.

    Confirmed diagnosis of dementia.

     
  3. 3.

    Have used the Books Beyond Words booklet for epilepsy in the past 12 months.

     

Consent

Discussion

This study is the first to assess the feasibility of undertaking a randomized controlled trial of an image-centric intervention, designed to facilitate the management of epilepsy in people with learning disabilities. The outputs of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities. As advocated by NICE, The Royal College of General Practitioners and the Learning Disabilities Observatory, improving disease management and access to services of people with learning disabilities and epilepsy is essential and should become a priority in routine care. Although the feasibility study will not demonstrate whether or not Books Beyond Words interventions can achieve those goals, and provide value for money, this will be addressed by the definitive trial. The results will therefore have significant and long-lasting implications for clinical practice and service delivery, whereby Books Beyond Words interventions could become routinely embedded in the NHS, yielding significant benefits for patients, their carers and the wider population.

Further, the results of the feasibility trial will be of utmost importance to patient groups and clinicians in raising awareness of emerging research in learning disabilities and epilepsy, and demonstrating the potential acceptability of this intervention. Dissemination of the results will primarily be achieved through publication in peer-reviewed scientific journals, and reports intended for people with learning disability, their carers, families and the wider lay community, disseminated through national and local patient networks, including the Making it Better Group, Inclusion East, and the British Institute of Learning Disabilities (BILD). Promoting the involvement of people with learning disabilities in research and demonstrating potential benefits will be another focus of our dissemination strategy. We will work closely with the BILD and with the Patient Involvement in Research Group to raise awareness and increase the representation of patients with learning disabilities and their carers in research.

Trial status

The trial set-up phase was completed at the end of May 2014. Recruitment started on 1 July 2014 and is expected to end in March 2015.

Abbreviations

BILD: 

British Institute of Learning Disabilities

CONSORT: 

Consolidated Standards of Reporting Trials

CTU: 

Clinical Trials Unit

ELDQOL: 

Epilepsy and Learning Disabilities Quality of Life (scale)

GCP: 

Good Clinical Practice

ISRCTN: 

International Standard Randomized Controlled Trial Number

NHS: 

National Health Service

NICE: 

National Institute for health and Clinical Excellence

NCTU: 

Norwich Clinical Trials Unit

PSS: 

Personal Social Services

SQL: 

Structured Query Language

WIELD: 

Wordless Intervention for Epilepsy in Learning Disabilities.

Declarations

Acknowledgements

The study team are grateful for the continued support and valuable contributions of the Patient Involvement in Research Group at the University of Hertfordshire, The Making Better Services Group, Inclusion East, the East of England Research Design Service, The Norwich Clinical Trials Unit, Books Beyond Words, and Professor Tim Gale at Hertfordshire Partnership University NHS Foundation Trust.

This study is funded by the NIHR Research for Patient Benefit program (reference number: RfPB PB-PG-0213-30042).

Authors’ Affiliations

(1)
Centre for Lifespan and Chronic Illness Research, Department of Psychology, School of Life and Medical Sciences, University of Hertfordshire, College Lane Campus, Hatfield, AL10 9AB, UK
(2)
The Dartmouth Institute for Health Policy and Clinical Practice, 37 Dewey Field Road, Hanover, NH 03755, USA
(3)
University of West London, Institute for Practice, Interdisciplinary Research and Enterprise (INSPIRE), A410, St Mary’s Road, Ealing, London, W5 5RF, UK
(4)
Hertfordshire Partnership University NHS Foundation Trust, 99 Waverley Rd, St Albans, Hertfordshire, AL3 5TL, UK
(5)
Norwich Medical School and Norwich Clinical Trials Unit, Faculty of Medicine and Health Sciences, University of East Anglia, Chancellor's Drive, Norwich, NR4 7TJ, UK
(6)
Department of Psychiatry, University of Cambridge School of Clinical Medicine, Cambridge Biomedical Campus, Box 189, Cambridge, CB2 2QQ, UK

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