[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660236":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":34,"armGroups":42,"interventions":48,"overallOfficials":54,"centralContacts":58,"locations":34,"responsibleParty":68,"collaborators":34,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":34,"studyType":85,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":96,"whyStopped":34,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":34},{"fullName":5,"class":6},"University Hospitals Cleveland Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":34},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Feasibility 1 - Session Attendance Rate","Percentage of scheduled intervention sessions attended during the 12-week intervention period. Each participant will be scheduled to attend 8 weekly intervention sessions; therefore, the total number of scheduled sessions will be calculated as the number of participants enrolled multiplied by 8 sessions.","8 weeks",{"measure":14,"description":15,"timeFrame":12},"Feasibility 2 - Intervention Sessions Retention","Proportion of participants who attended 75% of the sessions. Retention to sessions will be calculated as the number of participants attending at least 6 of the 8 scheduled intervention sessions divided by the total number of participants enrolled.",{"measure":17,"description":18,"timeFrame":19},"Feasibility 3 - Assessment Retention","Percentage of participants who complete both the baseline and 12-week assessments. Assessment retention will be calculated as the number of participants completing both assessments divided by the number of participants enrolled.","12 weeks",[21,25,28,31],{"measure":22,"description":23,"timeFrame":24},"Change in 30-Day Seizure Count","The 30-day seizure count is a standalone frequency metric determined by the total number of distinct clinical seizure events reported by the participant over a 30-day recall period. The score ranges from 0 to no upper limit, where a higher score indicates a worse clinical outcome (more frequent seizures).","Baseline, 12 weeks",{"measure":26,"description":27,"timeFrame":24},"Change in Negative Health Events (NHE) Total Score","The Negative Health Events (NHE) total score is calculated as the sum of the total number of distinct events occurring over a 6-month recall period across 5 categories: seizures, emergency department visits, inpatient hospital admissions, self-harm attempts, and accidents or traumatic injuries. The total score ranges from 0 to no upper limit, where a higher score indicates a worse clinical outcome (more frequent negative health events).",{"measure":29,"description":30,"timeFrame":24},"Change in PedsQL Epilepsy Module Standard Version Total Score","The PedsQL Epilepsy Module Standard Version Total Scale Score is a 29-item questionnaire assessing epilepsy-specific health-related quality of life (HRQOL) across five domains (Impact, Cognitive, Sleep, Executive Functioning, and Mood\u002FBehavior) with a standard 1-month recall period. Raw 5-point Likert scale items are reverse-scored and linearly transformed onto a 0 to 100 scale. The Total Scale Score represents the mean of all answered items. The total score ranges from 0 to 100, where a higher score indicates a better epilepsy-specific HRQOL.",{"measure":32,"description":33,"timeFrame":24},"Change in PedsQL Epilepsy Module Acute Version Total Score","The PedsQL Epilepsy Module Acute Version Total Scale Score is a 29-item questionnaire assessing epilepsy-specific health-related quality of life (HRQOL) across five domains (Impact, Cognitive, Sleep, Executive Functioning, and Mood\u002FBehavior) with an acute 7-day recall period. Raw 5-point Likert scale items are reverse-scored and linearly transformed onto a 0 to 100 scale. The Total Scale Score represents the mean of all answered items. The total score ranges from 0 to 100, where a higher score indicates a better acute, epilepsy-specific HRQOL.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"NA","SINGLE_GROUP","PREVENTION",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE","Pilot feasibility and acceptability trial of the SMART-Y intervention, which was modified from an evidence-based adult self-management program called Self-management for people with epilepsy and a history of negative health events (SMART). SMART is a remotely delivered\u002F real-time, group-format epilepsy self-management intervention that targets those who have had recent epilepsy-related complications and emphasizes management of lifestyle and emotions, as well as seizure control.\n\nThe study also enrolls peer educators who assist with intervention delivery. Demographic information will be collected from peer educators; however, peer educators do not receive the intervention as study recipients and are not included in analyses of participant outcomes.",[43],{"label":44,"type":45,"description":34,"interventionNames":46},"Experimental: [SMART-Y]","EXPERIMENTAL",[47],"Behavioral: SMART-Y",[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":34},"BEHAVIORAL","SMART-Y","SMART-Y is a youth-focused adaptation of SMART ( Self-MAnagement for people with epilepsy and a histoRy of negative health evenTs) developed for adolescents transitioning into adulthood. SMART is a remotely delivered, real-time group intervention that supports epilepsy self-management among individuals with recent epilepsy-related complications. The program emphasizes seizure control, lifestyle management, and emotional health.",[44],[55],{"name":56,"affiliation":5,"role":57},"Molly K McVoy, MD","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":34,"email":63},"Jessica O Surdam, MPH","CONTACT","216-844-7925","Jessica.Surdam@UHhospitals.org",{"name":65,"role":61,"phone":66,"phoneExt":34,"email":67},"Carla M Conroy, MPH","216-844-2871","Carla.Conroy@UHhospitals.org",{"type":57,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Molly McVoy","Physician","100660236","self-management-for-youth-with-epilepsy-pilot-100660236",false,"NCT07876102","Self-management for Youth With Epilepsy Pilot","Self-management for Youth With Epilepsy (SMART-Y) Phase 3","SMART-Y pilot","Inclusion Criteria:\n\n* Age 14-17\n* Diagnosed with epilepsy, per clinician or chart diagnosis\n* Has parent\u002Fguardian that is able\u002Fwilling to consent (parent does not have to also participate, just has to consent to the youth's participation)\n* Speaks English\n\nExclusion Criteria:\n\n* Comorbid Dx: moderate-severe intellectual disability\n* Unable to assent to the study\n* Unable to meaningfully participate in the intervention sessions or assessments","ALL","14 Years","17 Years",{"count":83,"type":84},18,"ESTIMATED","INTERVENTIONAL",[36],"Pilot feasibility and acceptability trial of the SMART-Y intervention in a small group of adolescents (n=18), age 14-17",[89],"Epilepsy",[89,91,92,93,94,95],"Self-Management","Adolescents","SMART","Feasibility and Acceptability","Pilot","NOT_YET_RECRUITING","2026-10-08",{"date":99,"type":100},"2026-10-15","ACTUAL",{"date":102,"type":84},"2026-11",{"date":104,"type":84},"2027-10",{"name":5,"class":6}]