A randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities
| ISRCTN | ISRCTN80067039 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80067039 |
| Secondary identifying numbers | 16588 |
- Submission date
- 23/04/2014
- Registration date
- 23/04/2014
- Last edited
- 16/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Marie-Anne Durand
Scientific
Scientific
College Lane
Hatfield
AL10 9AB
United Kingdom
| m.durand@herts.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities |
| Study acronym | Wordless Intervention for Epilepsy in Learning Disabilities (WIELD) |
| Study hypothesis | Epilepsy is the most common health problem that affects people with learning disabilities. It is more complex, more severe, and leads to more deaths in people with learning disabilities than in the general population who live with epilepsy. People with epilepsy and learning disabilities find it difficult to manage their illness. They do not have easy access to services and struggle to manage repeated seizures. They are often resistant to treatment, which can lead to premature deaths and increased costs. The guidelines of the National Institute for Health and Care Excellence recommend that patients with learning disabilities and epilepsy are offered the same standard of care, services and investigations as the general population. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities better understand and manage their condition and improve their quality of life. This intervention has never been formally evaluated and its effectiveness remains unknown. Given the lack of research in this area, it is recommended that this intervention is evaluated in a feasibility trial. This will determine whether a larger trial can be undertaken and what sample size, design and methods are most appropriate. The acceptability, potential effectiveness and cost effectiveness of using the booklet for epilepsy will also be explored. Eligible patients with epilepsy and learning disabilities will be randomised to receive either the Books Beyond Words booklet for epilepsy or routine information and care. In the intervention group, the booklet will be used at the Epilepsy Clinic with a Research Nurse and Carer, and later at home with the carer or family. Outcomes will be measured at 1, 3 and 5 months. Semi-structured interviews will also be used to assess the feasibility and acceptability. |
| Ethics approval(s) | MREC;17/04/2014; ref. 14/WA/0135 |
| Condition | Managing epilepsy in people with learning disabilities |
| Intervention | The Books Beyond Words booklet: Getting on with Epilepsy, uses pictures to tell a story about a young man with learning disabilities and epilepsy who progressively learns how to better manage epilepsy and recurrent seizures. All images have been tested with people with mild and severe learning disabilities to ensure understanding. The intervention aims to improve seizure control, reduce the risk of falls and seizure-related injuries, and improve quality of life. It also aims to illustrate best Follow Up Length: 5 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | Quality of life [Epilepsy and Learning Disabilities Quality of Life (ELDQOL) scale]; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3) |
| Secondary outcome measures | 1. Demographic data; Timepoint(s): Baseline (T0) 2. Discontinuation rates; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3) 3. EQ-5D; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3) 4. Feasibility and acceptability of study procedures and intervention; Timepoint(s): week 20 (T3) 5. Intervention's patterns of use; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3) 6. Rates of recruitment; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3) 7. Resource use; Timepoint(s): Baseline (T0), week 20 (T3) 8. Seizure control; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3) 9. Seizure severity; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3) |
| Overall study start date | 01/07/2014 |
| Overall study end date | 29/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Participant inclusion criteria | 1. Male and female patients, over 18 years of age 2. A confirmed clinical diagnosis of epilepsy (according to medical notes) and at least one seizure over the past 12 months 3. A confirmed clinical diagnosis of a learning disability (significantly below-average general intellectual functioning and an IQ below or equal to 70) 4. Ability to communicate verbally. The patient has a vocabulary of more than 10 words and can use 1 to 2 words, or more, to communicate 5. The carer is sufficiently proficient in English to read and complete the questionnaires with the patient |
| Participant exclusion criteria | 1. Vision impairment 2. Confirmed diagnosis of dementia 3. Has used the Books Beyond Words booklet for epilepsy in the past 12 months |
| Recruitment start date | 01/07/2014 |
| Recruitment end date | 29/02/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
College Lane
Hatfield
AL10 9AB
United Kingdom
AL10 9AB
United Kingdom
Sponsor information
Hertfordshire Partnership Foundation NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
99 Waverley Road
St. Albans
AL3 5TL
England
United Kingdom
"ROR" |
https://ror.org/0128dmh12 |
|---|
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB); Ref.: PB-PG-0213-30042
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/11/2014 | Yes | No | |
| Results article | results | 10/11/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/03/2020: Internal review.
13/02/2017: Publication reference added.
