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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: SMART RM; Drug: Valtoco Nasal Product

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kari M Zimmermann, MA; Phone Number: 2163688775; Email: kmz24@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Medical Center
      • Contact: Kari M Zimmermann, MA; Phone Number: 216-368-8775; Email: kmz24@case.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: 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).; Drug: Valtoco Nasal Product; Medication dosing will follow recommendations in the Valtoco package insert and managed by the epilepsy clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in number of seizures as measured by patient report.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life as measure by QOLIE-31	Quality of life (QOL) will be assessed using the QOLIE-31, a validated tool to assess quality of life specifically in people with epilepsy with higher numbers reflecting a more favorable health state.	Baseline, 10 week, 24 week
Change in functional status as measure by Short-Form Health Survey (SF-36)	Functional status will be assessed using the 36-item Short-Form Health Survey (SF-36), a multipurpose, short-form health survey with 36 questions that yields two psychometrically based components: a physical component summary and mental component summary. Scores range from 0 (worst functioning) to 100 (best functioning). The SF-36 is a generic measure of functional health status and has proven useful for comparing the relative burden of diseases.	Baseline, 10 week, 24 week
Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9)	Depressive symptom severity will be assessed using the nine- item Patient Health Questionnaire (PHQ-9), a widely used and validated self-rated depression scale. The PHQ-9 incorporates Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria, with scores ranging from 0 to 27. Higher scores indicate worse depression severity. The PHQ-9 has been widely used to measure depressive symptom severity in epilepsy.	Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES)	Self-efficacy will be measured using the 33-item Epilepsy Self-Efficacy Scale (ESES), with scores ranging from 0 to 330 and higher scores indicating better self-efficacy. Social support will be measured with the 12-item.	Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS)	Multidimensional Scale of Perceived Social Support (MSPSS), which measures perception of social support provided by family and friends, as well as satisfaction with that support. The MSPSS score ranges from 1 to 84, with higher scores indicating better social support.	Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS)	Overall epilepsy self-management competency will be measured using the Epilepsy Self-Management Scale (ESMS); scores range from 1 to 190, with higher scores indicating better self-management of epilepsy.	Baseline, 10 week, 24 week
Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS)	Stigma for epilepsy will be measured using the Epilepsy Stigma Scale (ESS) In the ESS, scores range from 7 to 70; each item is rated on a 7-point scale from strongly disagree to strongly agree, with higher numbers indicating greater perceived stigma	Baseline, 10 week, 24 week
Change in number of emergency room visit as measure by patient report		Baseline, 10 week, 24 week
Change in number of hospitalizations as measure by patient report		Baseline, 10 week, 24 week
Change in number of non study outpatient services utilization as measure by patient report		Baseline, 10 week, 24 week

Collaborators and Investigators

• Sponsor: Martha Sajatovic
• Investigators: Principal Investigator: Martha Sajatovic, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Epilepsy; Seizure; Anti-seizure medication; Epilepsy Self Management; Reduction medication
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: STUDY20230921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No