Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
- Disease/Condition
- Epilepsy
- Drug/Device/Intervention
- SMART RM
- Study type
- Interventional
- Intervention type
- behavioral
- Primary sponsor
- Martha Sajatovic
- Funder
- University Hospitals Cleveland Medical Center
- Location
- Cleveland, United States of America
- Phase
- Phase 4
- Start date
- Mar 05, 2024
- End date
- Jan 01, 2026
- Enrollment
- 43 participants
Change in number of seizures as measured by patient report.
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06346262
- Type
- Non-Device Trial
Access comprehensive clinical trial information for NCT06346262 through Pure Global AI's free database. This Phase 4 trial is sponsored by Martha Sajatovic and is currently Recruiting. The study focuses on Epilepsy. Target enrollment is 43 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.