[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583954":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":89,"collaborators":92,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":24,"eligibilityCriteria":101,"healthyVolunteers":98,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":24,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of Utah","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MyChildCMC group","EXPERIMENTAL","MyChildCMC is an app designed to support remote monitoring of CMC crosscutting symptoms to identify signs of CMC's health deterioration early to change their care early to avoid progression and prevent ED\u002Fhospital admissions. The app includes the following features: 1) automated reminders, 2) vital sign\u002Fsymptom monitoring, 3) real-time feedback system, 4) automated and real-time summary reports with longitudinal graphs, 5) automated alerts to a care coordinator, and 6) clinic dashboard connecting patients to clinics and allowing access to patient data to support care coordination. Those randomized to MyChildCMC will use the app daily for 6 months to monitor vital signs\u002Fsymptoms. They will also receive a sensor (Masimo Mighty Sat) to facilitate collection of Oxygen saturation, heart rate and respiratory rate, as well as financial incentive for daily monitoring (monitoring incentive) for 6-months and for responding to surveys.",[13],"Other: MyChildCMC app (an app designed to facilitate home monitoring of CMC's health status)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care group","ACTIVE_COMPARATOR","Those assigned to usual care will use a paper diary to monitor their vital signs and symptoms daily for 6 months. They will also receive a sensor (Masimo Mighty Sat) to facilitate collection of Oxygen saturation, heart rate and respiratory rate, as well as financial incentive for daily monitoring (monitoring incentive) for 6-months and for responding to surveys.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"MyChildCMC app (an app designed to facilitate home monitoring of CMC's health status)","MyChildCMC is an app designed to support remote monitoring of CMC crosscutting symptoms to identify signs of CMC's health deterioration early to change their care early to avoid progression and prevent ED\u002Fhospital admissions. The app includes the following features: 1) automated reminders, 2) vital sign\u002Fsymptom monitoring, 3) real-time feedback system, 4) automated and real-time summary reports with longitudinal graphs, 5) automated alerts to a care coordinator, and 6) clinic dashboard connecting patients to clinics and allowing access to patient data to support care coordination.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Flory Nkoy, MD, MS, MPH","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Flory L Nkoy, MD, MS, MPH","CONTACT","8012134161","flory.nkoy@hsc.utah.edu",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Angela Zhu, BS","801-662-3675","angela.zhu@hsc.utah.edu",[40,64],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ann & Robert H. Lurie Children's Hospital of Chicago","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-87.65005,41.85003,{"lat":52,"lon":51},[55,59,62],{"name":56,"role":32,"phone":57,"phoneExt":24,"email":58},"Carolyn Foster, MD, MS","3122278526","CCFoster@luriechildrens.org",{"name":60,"role":32,"phone":57,"phoneExt":24,"email":61},"Peter Walsh, BS","pwalsh@luriechildrens.org",{"name":63,"role":28,"phone":24,"phoneExt":24,"email":24},"Caroly Foster, MD, MS",{"facility":65,"status":42,"city":66,"state":67,"zip":68,"country":46,"countryCode":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":49,"coordinates":70},[71,72],-111.89105,40.76078,{"lat":72,"lon":71},[75,77,78,80,83,85,87],{"name":27,"role":32,"phone":76,"phoneExt":24,"email":34},"8019105793",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":38},{"name":79,"role":28,"phone":24,"phoneExt":24,"email":24},"Nancy Murphy, MD",{"name":81,"role":82,"phone":24,"phoneExt":24,"email":24},"Bryan Stone, MD, MS","SUB_INVESTIGATOR",{"name":84,"role":82,"phone":24,"phoneExt":24,"email":24},"Kathy Sward, RN, PhD",{"name":86,"role":82,"phone":24,"phoneExt":24,"email":24},"Xiaoming Sheng, PhD",{"name":88,"role":82,"phone":24,"phoneExt":24,"email":24},"Carolyn Reynolds, RN, MS",{"type":28,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Flory Nkoy","Professor",[93],{"name":94,"class":95},"National Institute of Nursing Research (NINR)","NIH","100583954","a-novel-mhealth-intervention-to-improve-outcomes-of-children-with-medical-complexity-100583954",false,"NCT06883045","A Novel mHealth Intervention to Improve Outcomes of Children With Medical Complexity","Inclusion Criteria:\n\n* CMC, ages 1-18 years and their parents (or primary caregivers)\n* CMC (inpatients or outpatients) who receive care at participating sites (comprehensive care clinics for CMC)\n* Own (or provided) a smartphone or tablet with internet access\n* Speak English or Spanish.\n* CMCs are identified using an operational definition, as having: 1) multisystem chronic diseases involving ≥3 organ systems, 2) ≥3 HCPs involved in their care, 3) high fragility or frequent (≥2) or 1 prolonged (\\>10 days) hospitalization in the prior year, and\u002For 4) medical technology dependence.\n\nExclusion Criteria:\n\n* Critically ill CMC and infants.\n* CMC exhibit similar developmental and functional abilities and typically function below expected for a 7-year-old child, allowing inclusion of a wide age range in studies.\n* Infants were excluded as many CMC \\\u003C1 year have prematurity-related conditions that may resolve by age 2.\n* CMC \\>18 years of age were not included as some may transition to adult health care.\n* Note: No one will be excluded due to lack of smartphone\u002Finternet access. We estimated \\\u003C10% of families may not have a smartphone\u002Finternet, and will provide them low-cost tablets and cellular internet access.","ALL","1 Year","18 Years",{"count":106,"type":107},360,"ESTIMATED","INTERVENTIONAL",[110],"NA","Children with medical complexity (CMC) are the most vulnerable of children with chronic diseases, who have complex, multisystem chronic diseases affecting ≥3 organ systems, severe functional limitations and technology dependencies. CMC have high health care needs, and account for 40% of hospitalized children and 35% of all pediatric health care costs. Due to high medical fragility, CMC have frequent acute deteriorations superimposed on their chronic conditions, leading to recurrent emergency department (ED)\u002Fhospital admissions and affecting quality of life (QOL). To reduce ED\u002Fhospital admissions for CMC, remote monitoring is suggested, with use of mHealth apps to regularly assess their health status remotely and identify early signs of acute deterioration, allowing for early interventions to prevent ED\u002Fhospital admissions. Yet no app to support remote monitoring of CMC exists. Variable, multisystem conditions among CMC make it difficult to develop an app. Also, many CMC are at high-risk for health care inequities, with minorities having higher unmet needs, but the impacts of health care inequities and social determinants of health (SDOH) on ED\u002Fhospital admissions in CMC are rarely studied. Fortunately, ED\u002Fhospital admissions for CMC are often preceded by a limited set of shared (crosscutting) acute symptoms. These crosscutting symptoms rarely occur suddenly. Studies suggest that they usually start as subtle signs, often unnoticed by parents until they escalate to prompt an ED\u002Fhospital visit. Thus, crosscutting symptoms offer an opportunity for a novel and practical approach for developing a remote monitoring app for CMC, despite their multiple, variable underlying conditions. In a focus group, parents identified the crosscutting symptoms that most often preceded their children's hospital admissions, and conveyed their needs, preferences and key functionalities that led to MyChildCMC, the first app designed to monitor and identify early signs of crosscutting symptoms in CMC. In a pilot trial of 50 subjects, we confirmed feasibility of MyChildCMC use by parents, ability to detect early signs 2-14 days prior to ED\u002Fhospital admissions, and use leading significantly to fewer hospital days than controls. The current study will assess the efficacy and sustainability of MyChildCMC in a fully-powered 6-month, 2-arm (MyChildCMC vs usual care) trial of CMC (age 1-18 years) and their parents. Parents assigned to MyChildCMC will use the app daily for 6 months, both arms will receive financial incentive for participation, then we will stop the incentive and follow subjects for 6 more months to assess sustainability at 12 months. We will also assess if MyChildCMC use will help reduce or eliminate inequities in ED\u002Fhospital admissions. Specific Aims are: 1) Determine MyChildCMC's efficacy on 1.a. Child (ED\u002Fhospital use, hospital days and QOL) and 1.b. Parent (satisfaction, self-efficacy and stress) outcomes; 2) Compare ED\u002Fhospital use among racial\u002Fethnic and SDOH subgroups to assess potential effect of MyChildCMC on inequities.",[113],"Children With Medical Complexity","2026-01-08",{"date":116,"type":117},"2026-01-12","ACTUAL",{"date":119,"type":117},"2026-01-06",{"date":121,"type":107},"2029-03-31",{"name":5,"class":6},2]