[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532792":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":43,"centralContacts":47,"locations":12,"responsibleParty":56,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":12,"enrollmentInfo":71,"targetDuration":12,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":87,"whyStopped":12,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":12},{"fullName":5,"class":6},"Azienda Ospedaliero Universitaria di Sassari","OTHER",[8,13,16,19,22,25,28,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Trial 1 - control group","NO_INTERVENTION","On site visit every 3 months as for SoC",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Trial 1 - PROMs + spirometer group","On site visit every 6 months. Monthly remote PROMs evaluation + portable spirometer measurement to remotely monitor the disease.",{"label":17,"type":10,"description":18,"interventionNames":12},"Trial 2 - control group","Monthly on site visit and paper PROMs.",{"label":20,"type":10,"description":21,"interventionNames":12},"Trial 2- Social Network Chatbot","PROM answered remotely weekly + monthly on site, first by themselves with the aid of Chatbot on the electronic forms and then under direct supervision of the clinicians.",{"label":23,"type":10,"description":24,"interventionNames":12},"Trial 2- Phonebot","PROM answered remotely weekly + monthly at hospital, first by themselves with the aid of Phonebot on the electronic forms and then under direct supervision of the clinicians.",{"label":26,"type":10,"description":27,"interventionNames":12},"Trial 2 - Mobile app","PROM answered remotely weekly + monthly at hospital, first by themselves with the aid of Mobile app on the electronic forms and then under direct supervision of the clinicians.",{"label":29,"type":10,"description":30,"interventionNames":12},"Trial 3 - asthma + CRSwNP Spirometer","Airflow monitoring recorded remotely with Spirometer every 2 weeks + on site visit every 2 month to compare wearable device with the standard one.",{"label":32,"type":33,"description":34,"interventionNames":35},"Trial 3 - asthma + CRSwNP RFID","EXPERIMENTAL","Airflow monitoring with RFID (daily) + on site visit every 2 months to compare wearable device with the standard one.",[36],"Device: Radio Frequency IDentification (RFID) device",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":12},"DEVICE","Radio Frequency IDentification (RFID) device","RFID devices monitor breathing patterns by means of temperature measurements of the respiratory airflow. The temperature gradient of the air flow in and out of the airways can be correlated to the flow-based respiratory patterns. Accordingly, a temperature-based breath monitoring can be achieved by means of on-skin RFID sensors attached below the nose. Finally, a bilateral measurement of nostrils respiratory flow can provide more information since nasal cavities do not behave in the same way during a respiratory cycle.\n\nIn this project we will evaluate the possibility to perform domestic breath flow analysis by exploiting thin, lightweight and battery-less sensing plasters directly attached under the nose. The system includes a proper external reader interrogating the face sensors that is capable to directly communicate with smartphone\u002Fpc\u002Ftablet\u002Fcloud environment.",[32],[44],{"name":45,"affiliation":5,"role":46},"Francesco Bussu, MD","PRINCIPAL_INVESTIGATOR",[48,52],{"name":45,"role":49,"phone":50,"phoneExt":12,"email":51},"CONTACT","00390792644509","fbussu@uniss.it",{"name":53,"role":49,"phone":54,"phoneExt":12,"email":55},"Claudia Crescio, PhD","00390792644552","claudia.crescio@aouss.it",{"type":46,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Prof. Francesco Bussu","Professor",[60],{"name":61,"class":6},"University of Rome Tor Vergata","100532792","proof-of-concept-of-remote-management-of-chronic-inflammatory-airway-diseases-for-patient-empowerment-100532792",false,"NCT06217419","Proof of Concept of Remote Management of Chronic Inflammatory Airway Diseases for Patient Empowerment","PRECISION","Inclusion Criteria:\n\n* ≥ 18 years\n* affected by chronic rhino sinusitis and\u002For asthma\n* not diagnosed with head and neck or lung cancer\n* no cardiovascular or metabolic uncontrolled diseases\n* if woman, not pregnant or breastfeeding\n* able to understand and sign the informed consent and to perform procedures required by the protocol\n\nExclusion Criteria:\n\n* \\\u003C 18 years\n* affected by cancer or uncontrolled diseases\n* pregnant or breastfeeding women\n* uncompleted clinical history data\n* unable to sign the informed consent or to perform procedures required by the protocol","ALL","18 Years",{"count":72,"type":73},136,"ESTIMATED","INTERVENTIONAL",[76],"NA","Chronic rhinosinusitis (CRS) is a multifactorial disease characterized by persistent symptomatic inflammation of the mucosa of the nose and paranasal sinuses, with (CRSwNP) or without (CRSsNP) the presence of nasal polyps. It affects 5 to 12% of the general population. CRS is often associated with asthma, which has a prevalence of 4% in the general population, reaching 30%-70% among patients with CRS. The current standard clinical evaluation of patients for both diseases has two main components: a subjective one (self-assessment provided by the patient), based mainly on the PROMs (Patient-Reported Outcome Measures) questionnaire, and an objective one (formulated by the clinician). Questionnaires present accuracy and response rate problems that have been investigated in the literature, finding that short questionnaires, incentives, personalization of questionnaires as well as repeat sending strategies or telephone reminders have a beneficial impact on the quantity and quality of responses. Today there are many new channels provided by technology. Among them, AI chatbots have been used in a variety of healthcare domains such as medical consultations, disease diagnosis, mental health support and, more recently, risk communications for the COVID-19 pandemic, and can offer a better way to collect questionnaires. At the same time, the recent technical solution of new non-invasive techniques for RFID radio frequency identification devices allows subjective reports to be accompanied with objective reports.\n\nThe PRECISION project aims to evaluate systems for home monitoring of chronic rhinosinusitis (CRS) and asthma, two highly prevalent chronic diseases. The frequent association between the two pathological conditions is a further argument in support of the rationality of a common approach.\n\nAs regards the collection of PROMs, three acquisition channels will be compared: i) AI Chatbots; ii) PhoneBot; iii) Mobile application. Data will be analyzed in relation to patient profiles to define the quality and quality of response.\n\nRegarding objective evaluation, the project will investigate the efficiency of objective remote airflow measurements for both upper (CRS) and lower (asthma) airways using dedicated non-invasive systems based on RFID technology.",[79,80],"Chronic Rhinosinusitis With Nasal Polyps","Asthma",[82,83,84,85,80,86],"Chatbot","Patient empowerment","Chronic rhinosinusitis","Airway diseases","Patient-reported outcome measures (PROM)","NOT_YET_RECRUITING","2024-01-19",{"date":90,"type":91},"2024-01-22","ACTUAL",{"date":93,"type":73},"2024-02",{"date":95,"type":73},"2026-06",{"name":5,"class":6}]