Using seizure rescue medication as part of a comprehensive epilepsy self-management program
Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
This study is testing a new program that helps people with epilepsy learn how to use seizure rescue medication better and manage their condition through education and support.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06346262 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the SMART program by incorporating education and self-management support for the use of Rescue Medication (RM) among individuals with epilepsy who experience repetitive seizures. It will involve two phases, starting with stakeholder input from a community advisory board to refine the program based on personal experiences. Participants will engage in virtual meetings to discuss and review educational materials over a three-month period. The second phase will involve a six-month follow-up to assess the effectiveness of the adapted program.
Who should consider this trial
Good fit: Ideal candidates include adults with epilepsy who have experience using rescue medications and can communicate in English.
Not a fit: Patients who do not have epilepsy or are unable to participate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could empower patients with epilepsy to better manage their seizures and improve their quality of life.
How similar studies have performed: Other studies have shown success in using self-management programs for epilepsy, indicating potential for positive outcomes with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York and 1 other locations
- Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital — New York, New York, United States (Recruiting)
- University Hospitals Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Martha Sajatovic, MD — University Hospitals
- Study coordinator: Study Research Coordinator
- Email: jessica.black@uhhospitals.org
- Phone: 1-888-819-0004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.