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

Part of paid clinical trials in New York, New York.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT06346262
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SMART RM — BEHAVIORAL
    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).
  • Valtoco Nasal Product — DRUG
    Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

Study Details

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 Dates

Start date
Mar 5, 2024
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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). The intervention will be remotely delivered in a web-based format using a secure web teleconferencing system (such as Zoom) that will allow us to set up a virtual meeting room. Following the group-session series, participants will have 3 monthly telephone maintenance sessions lasting around 15 minutes. Maintenance session web/telephone calls will be made to study participants by a NE with experience in epilepsy and/or chronic health condition management.

Primary Outcome Measure

Change in number of seizures as measured by patient report. [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount Sinai, Mount Sinai HospitalNew YorkNew York10029-
University Hospitals Medical CenterClevelandOhio44106
Study Research Coordinator
[email protected]
1-888-819-0004

Find similar trials in New York, NY

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital· New York, NYUniversity Hospitals Medical Center· Cleveland, OH

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