Actively Recruiting
Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
Led by University Hospitals Cleveland Medical Center · Updated on 2026-03-23
30
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of epilepsy
- Be 18 years or older
- Have experience with Rescue Medication (RM)
- Be able to speak and understand English
- Be able to provide written informed consent to participate
- While on anti-epileptic medication, continue to experience bouts of seizures distinct from usual patterns
- Have experienced between 3 and 100 seizures in the past 6 months, with at least two seizures occurring within 48 hours if only 3 seizures occurred
- For caregivers: provide care support to an individual with epilepsy
- For providers: provide care for individuals with epilepsy including physicians, nurses, social workers, or psychologists
You will not qualify if you...
- Have had allergic reactions to diazepam
- Have medical or psychiatric conditions that contraindicate diazepam use
- Are prescribed opioid medications
- Have acute narrow angle glaucoma
- Have known dependence on benzodiazepines or benzodiazepine abuse
- Are actively suicidal or homicidal
- Have a diagnosis of dementia
- Are unable to provide written informed consent and lack a legally authorized representative
- Are unable to participate in study procedures
- Are pregnant
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
2
University Hospitals Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
S
Study Research Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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