Epilepsy & behavior : E&B · 2025
Development of a self-management tool for individuals with seizure clusters: Trial design and methodological report.
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McVoy Molly, Hirsch Eytan, Londono Luisa, Colón-Zimmermann Kari, Hanchin Karlee, Patel Davina N, Cho Jin Seok, Shih Evelyn K, Rabinowicz Adrian L, Carrazana Enrique, Sajatovic Martha
Аннотация
BACKGROUND: Despite advances in anti-seizure medications (ASMs) for people with epilepsy (PWE), adverse outcomes, negative health events (NHEs), and breakthrough seizures remain common. Rescue medication (RM) can better manage repetitive seizures, but barriers to RM use persist. Self-management for PWE and a history of NHEs (SMART) is an evidence-based epilepsy self-management program aimed at reducing barriers and maximizing facilitators to self-care in high-risk PWE.
METHODS: This 2-phase, ongoing clinical trial adapts SMART to integrate RM support for PWE with repetitive seizures. Phase 1, now completed, used input from an advisory board (AB) of PWE, caregivers, and clinicians to adapt the SMART curriculum to include diazepam nasal spray, an RM. Phase 2 will test the adapted curriculum (SMART-RM) in a 6-month prospective trial among adult PWE, measuring seizure counts from baseline to 6-month follow-up. Secondary outcomes include changes in quality of life, NHEs, functional status, and depression severity.
RESULTS: The AB for Phase 1 enrolled 6 individuals: 2 PWE, 2 caregivers, and 2 clinicians. Participants endorsed the need for evidence-based epilepsy self-management curricula that include RM support and positively reviewed the SMART curriculum's format and duration. Additional content requests included: 1) A seizure action plan with RM, 2) RM education for caregivers, 3) Customized care plans for PWE to support caregivers, 4) An RM-specific goal template, and 5) A template for RM-related discussion topics with care providers.
CONCLUSIONS: Integrating RM into an evidence-based epilepsy self-management curriculum offers a comprehensive care package with potential to improve care for PWE with seizure clusters.
METHODS: This 2-phase, ongoing clinical trial adapts SMART to integrate RM support for PWE with repetitive seizures. Phase 1, now completed, used input from an advisory board (AB) of PWE, caregivers, and clinicians to adapt the SMART curriculum to include diazepam nasal spray, an RM. Phase 2 will test the adapted curriculum (SMART-RM) in a 6-month prospective trial among adult PWE, measuring seizure counts from baseline to 6-month follow-up. Secondary outcomes include changes in quality of life, NHEs, functional status, and depression severity.
RESULTS: The AB for Phase 1 enrolled 6 individuals: 2 PWE, 2 caregivers, and 2 clinicians. Participants endorsed the need for evidence-based epilepsy self-management curricula that include RM support and positively reviewed the SMART curriculum's format and duration. Additional content requests included: 1) A seizure action plan with RM, 2) RM education for caregivers, 3) Customized care plans for PWE to support caregivers, 4) An RM-specific goal template, and 5) A template for RM-related discussion topics with care providers.
CONCLUSIONS: Integrating RM into an evidence-based epilepsy self-management curriculum offers a comprehensive care package with potential to improve care for PWE with seizure clusters.