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NCT06346262Recruiting

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

Martha SajatovicPhase 4ClinicalTrials.govbehavioral
Study focus
Disease/Condition
Epilepsy
Drug/Device/Intervention
SMART RM
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Martha Sajatovic
Funder
University Hospitals Cleveland Medical Center
Location
Cleveland, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Mar 05, 2024
End date
Jan 01, 2026
Enrollment
43 participants
Primary outcome

Change in number of seizures as measured by patient report.

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.

ICD-10 classifications
EpilepsyEpilepsy, unspecifiedOther epilepsyStatus epilepticusOther status epilepticus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06346262
Type
Non-Device Trial
About this record

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.