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Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary and study completion pushed from Sep 1, 2026 to Dec 31, 2026
    • Enrollment target: estimated 30 to confirmed 31
    • Site details revised at 2 of 2 sites
    v6
  2. Study sites: 1 to 2v5
  3. Primary and study completion dates: Jan 1, 2026 to Sep 1, 2026v4
  4. Enrollment target: 43 to 30
    • Eligibility criteria expanded, about 31 words
    v3
  5. Lead sponsor: Martha Sajatovic to University Hospitals Cleveland Medical Center
    • Site contact updated
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings. Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.
Trial Details
NCT Number NCT06346262
Lead Sponsor University Hospitals Cleveland Medical Center
Conditions
(from sponsor)		 Epilepsy
Related terms Epilepsy, Seizures
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov