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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80067039

Enrollment

Registered

2014-04-23

Start date

2014-07-01

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Managing epilepsy in people with learning disabilities Nervous System Diseases Epilepsy

Interventions

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 epilep

Study Entry : Single Randomisation only

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Primary

Measure	Time frame
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)	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026