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

University Hospitals (UH)

Status and phase: Enrolling; Phase 4

Conditions: Epilepsy

Treatments: Drug: Valtoco Nasal Product; Behavioral: SMART RM

Study type: Interventional

Funder types: Other

Identifiers

NCT06346262

STUDY20230921

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Inclusion criteria for PEs:

• 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

Inclusion criteria for participants who will receive SMART-RM:

• 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 3 seizures but not more than 100 seizures in the previous 6 months. If there have only been 3 seizures in the last 6 months, two of the seizures should be within approximately 24 hours of each other (not more than 48 hours apart)
• Be able to speak and understand English
• Be able to provide written, informed consent to study participation

Exclusion criteria

Exclusion criteria for participants who will receive SMART-RM:

• Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam
• Individuals prescribed opioid medications
• Individuals with acute narrow angle glaucoma
• Individuals with known dependence on benzodiazepines or current benzodiazepine abuse.
• Actively suicidal/homicidal
• Individuals with a diagnosis of dementia
• Individuals who are unable to provide written informed consent to participate in study and who do not have a legally authorized representative or individuals who are unable to participate in study procedures.
• Pregnant women

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SMART RM

Experimental group

Description:

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.

Treatment:

Behavioral: SMART RM

Drug: Valtoco Nasal Product