A randomised controlled feasibility trial of the Books Beyond Words intervention to improve the management of epilepsy in people with learning disabilities

Not Applicable

Completed

• Conditions: Managing epilepsy in people with learning disabilities; Nervous System Diseases; Epilepsy

• Registration Number: ISRCTN80067039
• Lead Sponsor: Hertfordshire Partnership Foundation NHS Trust (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25414095 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/28186943

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-23
• Study Completion: 2016-02-29
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Demographic data; Timepoint(s): Baseline (T0)<br> 2. Discontinuation rates; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)<br> 3. EQ-5D; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)<br> 4. Feasibility and acceptability of study procedures and intervention; Timepoint(s): week 20 (T3)<br> 5. Intervention's patterns of use; Timepoint(s): baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)<br> 6. Rates of recruitment; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)<br> 7. Resource use; Timepoint(s): Baseline (T0), week 20 (T3)<br> 8. Seizure control; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)<br> 9. Seizure severity; Timepoint(s): Baseline (T0), week 4 (T1), week 12 (T2), week 20 (T3)<br>