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

ID#: NCT06346262

Age: 18 years - 66+

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: March 05, 2024

End Date: September 01, 2026

Contact Information:
Study Research Coordinator
1-888-819-0004
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:

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
Find a Clinical Trial Find Cancer Clinical Trials