protocolSection identificationModule nctId: NCT06346262, orgStudyIdInfo id: STUDY20230921, briefTitle: Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Martha Sajatovic, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: SMART RM, interventions name: Valtoco Nasal Product, outcomesModule primaryOutcomes measure: Change in number of seizures as measured by patient report., secondaryOutcomes measure: Change in quality of life as measure by QOLIE-31, secondaryOutcomes measure: Change in functional status as measure by Short-Form Health Survey (SF-36), secondaryOutcomes measure: Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES), secondaryOutcomes measure: Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS), secondaryOutcomes measure: Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS), secondaryOutcomes measure: Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS), secondaryOutcomes measure: Change in number of emergency room visit as measure by patient report, secondaryOutcomes measure: Change in number of hospitalizations as measure by patient report, secondaryOutcomes measure: Change in number of non study outpatient services utilization as measure by patient report, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Medical Center, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Kari M Zimmermann, MA, role: CONTACT, phone: 216-368-8775, email: kmz24@case.edu, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False