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

Last updated: December 18, 2024
Sponsor: University Hospitals Cleveland Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Epilepsy

Treatment

SMART RM

Valtoco Nasal Product

Clinical Study ID

NCT06346262
STUDY20230921
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 ofseizures (e.g. frequent break through or acute repetitive seizures) distinct fromtheir 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

Exclusion Criteria:

Exclusion criteria for participants who will receive SMART-RM:

  • Individuals who have had allergic reaction to diazepam or who havemedical/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 benzodiazepineabuse.

  • Actively suicidal/homicidal

  • Individuals with a diagnosis of dementia

  • Individuals who are unable to provide written informed consent to participate instudy and who do not have a legally authorized representative or individuals who areunable to participate in study procedures.

  • Pregnant women

Study Design

Total Participants: 43
Treatment Group(s): 2
Primary Treatment: SMART RM
Phase: 4
Study Start date:
March 05, 2024
Estimated Completion Date:
January 01, 2026

Connect with a study center

  • University Hospitals Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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