[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"children-with-medical-complexity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:children-with-medical-complexity":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,67,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Children With Medical Complexity","RECRUITING","2026-01-08",{"date":30,"type":31},"2026-01-12","ACTUAL",{"date":33,"type":31},"2026-01-06",{"date":35,"type":20},"2029-03-31",{"name":37,"class":38},"University of Utah","OTHER",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100532725","e-prime-for-children-with-medical-complexity-100532725","NCT06216548","E-PRIME For Children With Medical Complexity","Enhanced Primary Care Via Telehealth for Children With Medical Complexity","E-PRIME","Inclusion Criteria:\n\n* Less than 18 years of age on the date of enrollment (date consented)\n* Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months\n* Complexity of the condition, defined as needing ongoing care with 4 sub-specialists\u002F services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)\n\nExclusion Criteria:\n\n* CMC whose permanent address is outside of the state of North Carolina\n* CMC at a long-term care facility\n* CMC who are wards of the state, except when the caregiver is a legal guardian and can consent\n* CMC whose caregivers do not speak English or Spanish","17 Years",{"count":50,"type":20},909,[23],"Children with medical complexity (CMC) have very high needs for health and support services. CMC have very rare diseases that involve multiple organ systems. As a result, all CMC have multiple chronic conditions and need care from many specialists and services. While there are important benefits to the child and family in living at home, the continuing need for complex medical care places a profound burden on caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.",[26],[55,56,57],"Collaboration","Providers","Telehealth","2026-01-05",{"date":28,"type":31},{"date":61,"type":31},"2024-06-19",{"date":63,"type":20},"2028-04",{"name":65,"class":38},"Wake Forest University Health Sciences",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":66},"100556493","lets-eat-eating-with-assistive-technology-an-intervention-to-support-children-with-feeding-tubes-and-tracheostomies-100556493","NCT06525818","Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies","Inclusion Criteria:\n\n* Under 3 years of age\n* Reside at a family home\n* Have a gastrostomy feeding tube\n* Have a tracheostomy\n* Live within a 1-hour radius of the University of Chicago\n\nExclusion Criteria:\n\n• Wards of the state","3 Years",{"count":75,"type":20},40,[23],"The overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person\u002Fvirtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech\u002Flanguage pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims:\n\nSpecific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention.\n\nSpecific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention.\n\nThe investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist.\n\nThe weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.",[79,26,80,81],"Feeding Tube","Tracheostomy","Feeding Disorder, Infancy or Early Childhood","2025-08-11",{"date":84,"type":31},"2025-08-12",{"date":86,"type":31},"2024-07-08",{"date":88,"type":20},"2027-07-07",{"name":90,"class":38},"University of Chicago",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":15,"minAge":99,"maxAge":17,"enrollmentInfo":100,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":66},"100562148","bridging-hospital-to-home-for-children-with-medical-complexity-and-their-families-100562148","NCT06599398","Bridging Hospital to Home for Children with Medical Complexity and Their Families","Bridging Hospital to Home for Children with Medical Complexity and Their Families: the Effectiveness of a Transitional Care Unit (the \"Jeroen Pit Huis\")","BRIDGE","Subject eligibility (or inclusion) criteria for this are as follows:\n\n1. Age: at term (older than 37 weeks corrected gestational age) and younger than 18 years\n2. Admitted to the hospital with (a deterioration of) a chronic complex condition (CCC) \\[30\\] and\u002For (expected) continuous dependence on technology after discharge (see ad 2 below).\n3. Expected need of specialized medical and\u002For allied health care after discharge\n4. A stable medical condition and\u002For a set treatment regimen (see below ad 4)\n5. Discharge home not yet possible due to organization-, care- or family circumstances (see below ad 5)\n6. Have given informed consent (consenting process is described in chapter 11.2 recruitment and consent)\n\nAd 2 chronic complex condition Fulfils criteria of a chronic complex condition (CCC) \\[30\\] and\u002For (expected) continuous dependence on technology after discharge.\n\nA complex chronic condition (CCC) is defined according to Feudtner et al. (1) as \"any medical condition that can be reasonably expected to last at least 12 months (unless death intervenes) and to involve either several different organ systems or one organ system severely enough to require specialty pediatric care and probably some period of hospitalization in a tertiary care center.\" Verlaat et al., updated the CCC list based on expert opinion \\[31\\]. A table of diagnosis classified as CCC can be found in appendix 1. An unknown but suspected complex and chronic condition, such as a child born with multiple congenital anomalies but lacking a unifying diagnosis, will be included.\n\nAd 4 stable medical condition\n\nThe patient is defined as being in a stable medical condition if there is:\n\n1. A patent, safe airway to remain in the home situation, whether or not by means of a trachea cannula\n2. Adequate respiration, whether or not by means of (intermittent) support with oxygen, non-invasive ventilation or invasive ventilation via a trachea cannula\n3. A neurologically stable condition that may include temporary neurological impairments (such as seizures) not interfering (potentially life-threatening) with other vital functions such as respiration or circulation\n4. Drug treatment that can be given at home where (if applicable): a nasogastric, duodenal or jejunal tube and\u002For a percutaneous endoscopic gastrostomy (PEG) tube is in situ, or if necessary, a 'home-proof' intravenous access is guaranteed\n5. In case of enteral tube feeding, the nasogastric, duodenal or jejunal tube and\u002For a percutaneous endoscopic gastrostomy (PEG) tube is in situ, and the feeding schedule may be built up, reduced or variable if there are no contraindications for this. In case of parenteral feeding, the parenteral nutrition home program must be organized according to the home situation.\n\nAd 5 organization-, care- or family circumstances include the lack of 1 or more of the following requirements for safe discharge home:\n\n1. A sustainable care plan using the four 'Medische Kindzorg Systeem' domains (medical, safety, development and social) has been drawn up that includes all four domains such as among others (Medical Child care System that is used in The Netherlands to structure medical child care in the home situation):\n\n   * care needs\n   * clear coordination of tasks and responsibilities of parents and healthcare professionals (primary, secondary and tertiary care).\n2. The necessary medical and nursing care support (such as a feeding pump, adequate home care).\n3. Parents know who to contact with questions about the organization of care (e.g. financial issues, wheelchair, municipality)\n4. Essential medical technology is available at home and can be used for care.\n5. Reimbursement of care at home is adequately arranged.\n6. The house is located and furnished in such a way that the child can stay in it safely (accessibility for emergency services, telephone contact with parents, technical facilities)\n\n   Parents\u002Finformal carers are adequately trained to take care of the child in the home situation, that means that they:\n7. Master care in all areas (medical, nursing, technical, psychosocial)\n8. Obtain declaration of care competencies, in particular:\n\n   * assessment for somatic deterioration\n   * acting in emergency situations (e.g. seeking help, resuscitation and if applicable: cannula dislocation, PEG probe problems, docking of a seizure)\n   * realizing when to call for help and whom to call for help\n9. Can obtain adequate telephone assistance (working telephone, English\u002FDutch speaking)\n10. Are psychologically and emotionally ready to deal with new home situation (according to care professionals)\n\nA potential subject will be excluded from participation in this study if:\n\n1. The patient is in need of end-of-life care\n2. Existence of predominantly social\u002Ffamily issues without serious medical problems in the index child\n3. Patient with behavioural\u002Fpsychiatric problems necessitating other type of care\n4. Patient requiring rehabilitation medical care\n5. Patients who are not directly discharged home from the hospital (except for the JPH (e.g. via de Boeg, Villa Expert Care))\n6. Contagious disease that requires strict isolation","0 Minutes",{"count":101,"type":20},150,"OBSERVATIONAL","The goal of this observational study is to evaluate an innovative pediatric transitional care unit called the Jeroen Pit Huis (JPH). The primary objective of our study is to investigate whether an intermediate stay between hospital and home in the JPH have a favourable effect on healthcare consumption, patient, parent and family-relevant quantitative outcome measures, compared to discharge directly from a hospital ward. Parents will be asked to complete several questionnaires on three different time points (at discharge, 3 and 12 months of follow up).",[105],"Children with Medical Complexity",[105],"2024-09-13",{"date":109,"type":31},"2024-09-19",{"date":111,"type":31},"2023-12-01",{"date":113,"type":20},"2026-06-01",{"name":115,"class":38},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]