Table 1

Study outcome measures

OutcomeData collection methodT0
Baseline
T1
Week 4
T2
Week 12
T3
Week 20
Number of eligible patients and number recruitedCase report form
Discontinuation rates across both groups and reasonsCase report form
Demographic dataQuestionnaire: context-specific questions about age, sex, ethnicity, and living circumstances of the participant, the type of care provided by the carer and their relationship to the participant
Patterns of use of the Beyond Words booklet (intervention group only)Questionnaire: context-specific questions
Use of other epilepsy-related informationQuestionnaire: context-specific questions
Quality of life as the primary outcome measureQuestionnaire: ELDQOL scale, which consists of four subscales: behaviour, seizure severity, mood and side effects32 33
Seizure severity as a secondary outcome measureQuestionnaire: ELDQOL seizure severity subscale
Seizure control as a secondary outcome measureSeizure diary
Health-related quality of lifeQuestionnaire: EQ-5D-5L index and visual analogue scale (EQ-VAS)—proxy version34
Health and social services and resources useQuestionnaire: context-specific resource use questions
Feasibility and acceptability of the study proceduresSemistructured interview
Use and perceived usefulness of existing resources and servicesSemistructured interview
Information and self-management support needsSemistructured interview
Perceived acceptability of the interventionSemistructured interview
Perceived barriers and facilitators to the use and dissemination of the intervention in routine careSemistructured interview