Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346262
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-22
Brief Title:
Seizure Rescue Medication RM as Part of a Comprehensive Epilepsy Self-management Package of Care
Sponsor:
Martha Sajatovic
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Seizure Rescue Medication RM as Part of a Comprehensive Epilepsy Self-management Package of Care
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 contentsupport materials pending input stakeholder might include postershand-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 minutesmeeting 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None