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Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
Sponsor: University Hospitals Cleveland Medical Center
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-03-05
Completion Date
2026-09-01
Last Updated
2026-03-23
Healthy Volunteers
Yes
Conditions
Interventions
SMART RM
The SMART-RM will consist of 8 group-format, 45-60 minute sessions (up to 11 participants per group), which will be collaboratively delivered by a Nurse Educator (NE) and a Peer Educator (PE).
Valtoco Nasal Product
Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.
Locations (2)
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital
New York, New York, United States
University Hospitals Medical Center
Cleveland, Ohio, United States