[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491710":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":24,"responsibleParty":37,"collaborators":24,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":24,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":24,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":24,"overallStatus":60,"whyStopped":24,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":24},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","ACTIVE_COMPARATOR","Usual care for children with preschool wheeze consist of regular visits to the outpatient clinic every three months after starting the study, while in between these visits contact with the healthcare team is by telephone as needed. At inclusion and at every outpatient clinical visits (e.g. 3, 6, 9 and 12 months), parents\u002Fcaregivers will be asked to update the healthcare team on disease symptoms by completing a digital version of Test for Respiratory and Asthma Control in Kids (TRACK) questionnaire.",[13],"Other: Usual care",{"label":15,"type":16,"description":17,"interventionNames":18},"Luchtbrug Junior (intervention)","EXPERIMENTAL","Online monitoring via Luchtbrug Junior will replace 50% of the outpatient visits. Children in the intervention group will be monitored online monthly by a digital version of TRACK.",[19],"Other: Luchtbrug Junior (online monitoring)",[21,25],{"type":6,"name":22,"description":17,"armGroupLabels":23,"otherNames":24},"Luchtbrug Junior (online monitoring)",[15],null,{"type":6,"name":9,"description":26,"armGroupLabels":27,"otherNames":24},"Routine outpatient clinical visits every 3 months.",[9],[29],{"name":30,"affiliation":5,"role":31},"Lara van den Wijngaart, MD, PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","+31243614430","lara.vandenwijngaart@radboudumc.nl",{"type":38,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100491710","luchtbrug-junior-the-next-step-100491710",false,"NCT05682664","Luchtbrug Junior: the Next Step","Luchtbrug Junior: Online Monitoring for Young Children With Preschool Wheeze","Inclusion criteria\n\n* Children aged 2 to 6 years with a doctor's diagnosis of preschool wheeze\n* Children have an indication for regular follow-up of at least one year by a paediatrician because of respiratory symptoms;\n* Children are treated with inhaler medication, including inhaled corticosteroids;\n* A history of three episodes of wheezing managed by a healthcare professional of which at least one was observed by a paediatrician in the last 12 months prior to the study, or:\n* At least one hospital admissions due to pulmonary symptoms before inclusion.\n* Informed consent of parents\u002Fcaregivers\n\nExclusion criteria\n\n* Underlying chronic cardiopulmonary or neuromuscular condition, or known recurrent aspirations;\n* Underlying syndromes associated with pulmonary comorbidities;\n* Prematurity \\\u003C36 weeks after gestation;\n* Inability of parents\u002Fcaregivers\u002Fcaretakers to understand and\u002For read Dutch;\n* No access to a smartphone and\u002For internet.","ALL","2 Years","6 Years",{"count":50,"type":51},270,"ESTIMATED","INTERVENTIONAL",[54],"NA","Rationale:\n\nThe introduction of e-health in the monitoring and management of patients with chronic conditions can be beneficial and efficient. The introduction of an online monitoring and management tool, \"Luchtbrug\", for children 6-16 yrs of age with asthma while reducing 50% of visits to the outpatient clinic, results in similar or improved asthma control while reducing costs. It is highly likely that this concept of e-health is suitable for other chronic conditions. Therefore the aim of the study is to investigate the added value of online monitoring and management of children with preschool wheeze (2-6 yrs of age).\n\nObjective: To assess whether the number of symptom free days can be improved using online monitoring and disease management via Luchtbrug Junior, while reducing the number of outpatient clinic visits by 50%\n\nStudy design: Prospective multicentre (n=6) randomised trial in which disease management via Luchtbrug Junior will be compared with usual care.\n\nFollow-up: 12 months.\n\nStudy population: children aged 2-6 yrs with preschool wheezing (multiple episode of cough, wheeze and dyspnoea).\n\nIntervention (if applicable): Children will be randomised into usual care (n=135) or partly online care via Luchtbrug Junior (n = 135)\n\nMain study parameters\u002Fendpoints:\n\nPrimary objective: Number of symptom free days (SFDs) based on the TRACK questionnaire, during the last four weeks of the study (measured at 12 months).\n\nSecondary objectives:\n\nHealthcare consumption: unscheduled visits Emergency Department (ED) or outpatient clinic, unscheduled phone calls, hospital admissions) Questionnaires into: Quality of Life (QoL), cost-effectiveness (direct and indirect costs), self-management of patients, adherence to treatment, satisfaction of parents\u002Fcaregivers.\n\nUsual care consists of regular visits to the outpatient clinic every 3 months after starting the study. In between visits contact with the healthcare team is by telephone as needed. At 3, 6, 9 and 12 months, patients will be asked to complete the TRACK questionnaire.\n\nOnline care using Luchtbrug Junior will include visits to the outpatient clinic every 6 months after starting the study. In between visits, parents\u002Fcaregivers of the patient will be asked to answer the digital version of TRACK questionnaire monthly, therefore the parents\u002Fcaregivers will received email-reminders. Appropriate feedback on their TRACK-scores will be provided by their healthcare team within two working days. Any interventions such as adjustment of treatment are at the judgment of the treating pediatrician. Therapy adherence will be monitored during the study by using smart inhalers.",[57,58,59],"eHealth","Telemedicine","Wheezing","NOT_YET_RECRUITING","2024-06-07",{"date":63,"type":64},"2024-06-10","ACTUAL",{"date":66,"type":51},"2024-08-01",{"date":68,"type":51},"2027-02-01",{"name":5,"class":6}]