[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516016":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":49,"locations":58,"responsibleParty":93,"collaborators":95,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":27,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":74,"whyStopped":27,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-Intensity (Virtual) Intervention Implementation","ACTIVE_COMPARATOR","During low intensity implementation, families of children with poorly controlled asthma will be referred to the remote version of HARP (HARP-V) and will receive CASE remotely (CASE-V). Children with not well controlled asthma will receive only CASE-V remotely.",[13,14],"Behavioral: CASE in person version (High Intensity Package)","Behavioral: CASE-V remote version (Low Intensity Package)",{"label":16,"type":10,"description":17,"interventionNames":18},"High Intensity (in-Person) Intervention Implementation","During high intensity implementation, all interventions are administered in person.\n\nSpecifically, families of children with poorly controlled asthma will receive in-person versions of HARP and CASE. Children with not well controlled asthma will receive an in-person version of CASE only.",[19,20],"Behavioral: CASE and HARP in person (High Intensity package)","Behavioral: CASE-V and HARP-V remote version (Low Intensity package)",[22,28,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","CASE in person version (High Intensity Package)","Controlling Asthma in Schools Effectively (CASE) is a multi-level school-based asthma management program delivered by a Community Health Worker (CHW) that includes 1) staff training involving education on asthma management in school, 2) child-based asthma management education with an emphasis on control of symptoms in the school setting provided in a group setting during the school day, 3) caregiver education after school involving supporting children's asthma control in the school setting, 4), and provision of an Asthma Action Plan (AAP) to the school for child enrollees.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"CASE-V remote version (Low Intensity Package)","CASE-V, the low intensity version of CASE, includes similar child and caregiver-based asthma management education that is provided in a remote format with adaptation to integrate technological feature of Zoom. All CASE-V components (for staff, children, and parents) have been adapted to promote engagement (e.g., use of chat and polling function).",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"CASE and HARP in person (High Intensity package)","Children with \"poorly controlled\" asthma will receive both the CASE and HARP programs. HARP is a home-visiting program that includes individualized asthma management education and strategies and supplies for environmental remediation. All 3 visits can be conducted by a CHW. The first includes a \"walk-through\" to identify triggers. Asthma education and self-management strategies are provided using a structured protocol and low-literacy flip-book (English or Spanish). Referrals and advocacy are offered to address asthma management barriers (e.g., communication with landlord\u002Fhousing re: code violation). The 2nd and 3rd visits include delivery of supplies (e.g., HEPA vacuum, pest gels, mattress covers), instruction for use, review of AAP, and follow-up on environmental control recommendations provided during the 1st visit.",[16],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"CASE-V and HARP-V remote version (Low Intensity package)","HARP-V replicates the content delivered in HARP in a remote format. The first session includes a virtual \"walk-through\" in which the educator uses a structured script and checklist to guide the caregiver through the home and show specific components of the environment (e.g., carpeting, area under the kitchen sink, exhaust fan in bathroom) to identify asthma triggers. Asthma education and self-management strategies are provided using a structured protocol and slide overview based on the HARP flip-book. Supplies for environmental remediation are delivered prior to the 2nd visit. The 2nd and 3rd visit include instruction for use of supplies, review of AAP, and follow-up on recommendations and referrals.",[16],[41,44,46],{"name":42,"affiliation":5,"role":43},"Daphne Koinis Mitchell, PhD","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":5,"role":43},"Elizabeth L McQuaid, PhD, ABPP",{"name":47,"affiliation":48,"role":43},"Ligia Chavez, PhD","University of Puerto Rico",[50,54],{"name":42,"role":51,"phone":52,"phoneExt":27,"email":53},"CONTACT","401-793-8632","dkoinismitchell@lifespan.org",{"name":55,"role":51,"phone":56,"phoneExt":27,"email":57},"Elizabeth McQuaid, PhD, ABPP","401-444-7573","elizabeth_mcquaid@brown.edu",[59,72],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":27},"ACTIVE_NOT_RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-71.41283,41.82399,{"lat":70,"lon":69},{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":76,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Medial Sciences Campus, University of Puerto Rico","RECRUITING","San Juan","Puerto Rico","00937","PR",{"type":67,"coordinates":80},[81,82],-66.10572,18.46633,{"lat":82,"lon":81},[85,89],{"name":47,"role":51,"phone":86,"phoneExt":87,"email":88},"787-758-2525","1941","ligia.chavez@upr.edu",{"name":90,"role":51,"phone":86,"phoneExt":91,"email":92},"Keilyn Vale, MS","1994","keilyn.vale@upr.edu",{"type":94,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[96],{"name":48,"class":6},"100516016","the-puerto-rico-asthma-integrated-response-program-pr-air-100516016",false,"NCT05999032","The Puerto Rico Asthma Integrated Response Program (\"PR-AIR\")","PR-AIR","Inclusion Criteria:\n\n1. Children between the ages of 2 and 12 years old\n2. Children must reside in one of the identified catchment areas\n3. Children must meet the screening criteria as having not well controlled or poorly controlled asthma\n\nExclusion Criteria:\n\n1\\. Children with complex medical conditions","ALL","2 Years","12 Years",{"count":108,"type":109},480,"ESTIMATED","INTERVENTIONAL",[112],"NA","The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico.\n\nThe Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.",[115],"Pediatric Asthma",[117,118,119,120,121,122],"Pediatric asthma","Community intervention program","Hybrid Type III","Effectiveness and implementation","Home-based intervention","School-based intervention","2025-08-14",{"date":125,"type":126},"2025-08-20","ACTUAL",{"date":128,"type":126},"2024-12-16",{"date":130,"type":109},"2027-07-31",{"name":5,"class":6},2]