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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ Phase 1 Patient with epilepsy inclusion criteria:

• Have epilepsy

• Have experience with RM

• Be 18 years or older

• Be able to speak and understand English

• Be able to provide written, informed consent to study participation

⁃ Phase 1 Caregiver inclusion criteria

• Provide care support to an individual with epilepsy

• Be 18 years or older

• Be able to speak and understand English

• Be able to provide written, informed consent to study participation

⁃ Phase 1 Provider inclusion criteria

• Provide care for individuals with epilepsy - this may include (not limited to) physician, nurse practitioner, physician assistant, nurse, social worker, psychologist

• Be 18 years or older

• Be able to speak and understand English

• Be able to provide written, informed consent to study participation

• Have epilepsy

• Have experience with RM

• Be 18 years or older

• Be able to speak and understand English

• Be able to provide written, informed consent to study participation

• Have received a previous diagnosis of epilepsy

• Be adults ≥ age 18,

• While on a regimen of anti-epileptic medication, still be experiencing bouts of seizures (e.g. frequent break through or acute repetitive seizures) distinct from their usual seizure pattern , and, in the opinion of the study epilepsy clinician, may need benzodiazepine intervention for seizure control

• Have experienced at least 5 seizures but not more than 100 seizures in the previous 6 months.

• Be able to speak and understand English

• Be able to provide written, informed consent to study participation

Locations
United States
Ohio
University Hospitals Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Study Research Coordinator
jessica.black@uhhospitals.org
1-888-819-0004
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 43
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospitals Cleveland Medical Center

This content was sourced from clinicaltrials.gov