[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07707037":3,"trial-entities:NCT07707037":81,"trial-summary:NCT07707037":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":13,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":59,"locations":61,"central_contacts":76,"overall_officials":78,"references":79,"see_also_links":80},"NCT07707037","26-024333","Removing Surrogates Uncertainty to Reduce Fear and Anxiety After Cardiac Events - Kids","RECRUITING","2027-05-31","2026-07","2026-07-16","2026-06-01","Children's Hospital of Philadelphia","OTHER",false,"This pilot randomized controlled trial (RCT) will test the feasibility and acceptability of the informational intervention program, Heartsight, to reduce caregivers' uncertainty experienced throughout their child's illness trajectory after cardiac arrest. The investigator aims to enroll up to 30 caregivers of pediatric cardiac arrest patients to (Aim 1a) pilot recruitment and randomization (2:1) procedures, and (Aim 1b) estimate retention rate at 3 months and assess engagement and utilization metrics for frequency of access and time spent on each module of the informational packages. The investigator also aims to evaluate the association of the intervention with efficacy outcomes in an exploratory manner in preparation for a larger trial, including (Aim2a) a preliminary estimate of the association of intervention with the surrogate's uncertainty levels at 3 months post-discharge, and (Aim 2b) a preliminary estimate of the association of intervention with the surrogate's anxiety, depression, and post-traumatic stress symptoms at 3 months post-discharge.",null,[18,19,20],"Cardiac Arrest","Anxiety Depression","Family Support",[],"INTERVENTIONAL",[24],"NA",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":13,"name":30,"description":31,"armGroupLabels":32},"Education Intervention","Caregivers will receive education modules at multiple time points during their children's post cardiac arrest recovery trajectory",[33],"Intervention",[35],{"measure":36,"description":37,"timeFrame":38},"Retention Rate","Proportion of enrolled caregivers who complete the study requirements","3 months post enrollment",[40,44,46,49],{"measure":41,"description":42,"timeFrame":43},"Depression Screen as Measured by the Patient Health Questionnaire-4","The Patient Health Questionnaire-4 (PHQ-4) is used to quickly assess and measure symptoms of anxiety. Possible scores range from 0 to 6, where a score of 3 or greater is considered a positive screen.","Data is collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-hospital discharge will be reported.",{"measure":45,"description":42,"timeFrame":43},"Anxiety Screen as Measured by the Patient Health Questionnaire-4",{"measure":47,"description":48,"timeFrame":43},"Presence and Severity of Post Traumatic Stress Disorder Symptoms as Measured by the Posttraumatic Stress Disorder Checklist (PCL-5)","The Post Traumatic Stress Disorder Checklist (PCL-5) is used to assess the presence and severity of post traumatic stress disorder symptoms. Possible scores range from 0 to 80, with higher scores indicating greater symptom severity.",{"measure":50,"description":51,"timeFrame":43},"Uncertainty regarding a child's medical diagnosis, treatment, or health condition as measured by Parents' Perception of Uncertainty Scale (PPUS)","The Parents' Perception Uncertainty in Illness Scale (PPUS) is used to measure a parent's uncertainty surrounding their child's medical diagnosis, treatment, or health condition. Possible scores range from 32 to 160, with higher scores indicating a higher level of uncertainty.","ALL","0 Days","17 Years",{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion Criteria:\n\nCaregiver\n\n1. Caregiver of a child \\\u003C17.5 years of age who had at least a 2 minute cardiac arrest, is expected to be discharged within 30 days, and to survive at least 3 months post-discharge from hospital.\n2. English speaking\n\nChild\n\n1. \\\u003C17.5 years of age\n2. Have had a cardiac arrest lasting more than 2 minutes within the past 7 days and have not yet been discharged from pediatric intensive care unit (PICU) or cardiac intensive care unit (CICU)\n\nExclusion Criteria:\n\n1\\) Parent or legal guardian is not the child's caregiver",[60],"CHILD",[62],{"facility":12,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":73},"Philadelphia","Pennsylvania","19104","United States",[68],{"name":69,"role":70,"phone":71,"email":72},"Elizabeth Herrup, MD","CONTACT","215-514-0166","herrupe@chop.edu",{"lat":74,"lon":75},39.95238,-75.16362,[77],{"name":69,"role":70,"phone":71,"email":72},[],[],[],{"nct_id":4,"conditions":82,"biomarkers":85},[83,18,84],"Anxiety","Depression",[],{"nct_id":4,"found":87,"summary":88,"prompt_version":98},true,{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is a pilot randomized controlled trial, meaning participants are assigned to groups by chance. The study plans to enroll up to 30 caregivers.","completed","Heartsight Education for Caregivers After Pediatric Cardiac Arrest","This study, called Heartsight, is testing an education program for caregivers of children who have had a cardiac arrest. The program aims to help reduce the uncertainty, fear, and anxiety that caregivers might experience during their child's recovery. Caregivers will receive educational materials at different times after their child's cardiac arrest. We are looking for up to 30 caregivers of children under 17.5 years old who have had a cardiac arrest lasting at least two minutes and are expected to go home within 30 days. The main goal of this study is to see how many caregivers stay in the study for 3 months and how much they use the educational materials.","The study measures how many caregivers stay in the study for 3 months after they join.",112,"Caregivers will receive education modules at multiple times during their children's recovery after cardiac arrest.","Not stated in the trial record.",[],"v2"]