Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06346262
PHASE4

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

Sponsor: University Hospitals Cleveland Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-03-05

Completion Date

2026-09-01

Last Updated

2026-03-23

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

SMART RM

The SMART-RM will consist of 8 group-format, 45-60 minute sessions (up to 11 participants per group), which will be collaboratively delivered by a Nurse Educator (NE) and a Peer Educator (PE).

DRUG

Valtoco Nasal Product

Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

Locations (2)

Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital

New York, New York, United States

University Hospitals Medical Center

Cleveland, Ohio, United States