RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-05
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06346262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Individuals who have had allergic reaction to diazepam or who have medical/psychiatric that are contraindications to the use of diazepam
  2. * Individuals prescribed opioid medications
  3. * Individuals with acute narrow angle glaucoma
  4. * Individuals with known dependence on benzodiazepines or current benzodiazepine abuse.
  5. * Actively suicidal/homicidal
  6. * Individuals with a diagnosis of dementia
  7. * 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.
  8. * Pregnant women

Contacts and Locations

Study Contact

Kari M Zimmermann, MA
CONTACT
2163688775
kmz24@case.edu

Principal Investigator

Martha Sajatovic, MD
PRINCIPAL_INVESTIGATOR
University Hospitals

Study Locations (Sites)

University Hospitals Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Martha Sajatovic

  • Martha Sajatovic, MD, PRINCIPAL_INVESTIGATOR, University Hospitals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-05
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-03-05
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Epilepsy Self Management
  • Epilepsy
  • Seizure
  • Reduction medication
  • Anti-seizure medication

Additional Relevant MeSH Terms

  • Epilepsy