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

ConditionEpilepsy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Have epilepsy

Have experience with RM

Be 18 years or older

Be able to speak and understand English

Disqualifiers

Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam

Individuals prescribed opioid medications

Individuals with acute narrow angle glaucoma

Individuals with known dependence on benzodiazepines or current benzodiazepine abuse.

Trial design

Treatments tested in this trial

  • SMART RM
  • Valtoco Nasal Product

Treatment groups

30 Participants
are divided into 1 treatment group