[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657413":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":44,"studyPopulation":38,"armGroups":45,"interventions":52,"overallOfficials":58,"centralContacts":63,"locations":73,"responsibleParty":94,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":38,"studyType":114,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":76,"whyStopped":38,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":38},[9,13,16,20,24,27,30],{"measure":10,"description":11,"timeFrame":12},"Patient Adoption","Proportion of enrolled patients who start using the digital platform. Results will be reported as percentage of enrolled patients who access the platform at least once.","From enrollment to the end of bariatric follow up at 18 month after surgery",{"measure":14,"description":15,"timeFrame":12},"Protocol Adherence","Protocol adherence will be assessed as the percentage of enrolled patients who complete the study protocol.",{"measure":17,"description":18,"timeFrame":19},"Patient's satisfaction with the digital platform","Patient satisfaction will be assessed using the Q9Program satisfaction questionnaire administered through the app 180 days after discharge. The questionnaire consist of 10 items rated on a 1-to-10 scale. Item score will be summed to obtain a total satisfaction score rating from 10 to 100.","180 days after discharge",{"measure":21,"description":22,"timeFrame":23},"Healthcare Professional platform use","Healthcare professional platform use will be assessed as the average number of logins per healthcare professional per week.","From enrollment to 18 month after surgery",{"measure":25,"description":26,"timeFrame":12},"Alert Management: alert volume","* Number of alerts\n* Number of alerts per patient\n* Number of alerts per patient group (e.g. age, time within the care pathway, etc.)\n* Number of postoperative alerts",{"measure":28,"description":29,"timeFrame":12},"Alert Management: Types of Alerts Generated","Will be collected the Type of alerts (n.\u002F%, clinical or administrative) and type of clinical alerts (n.\u002F%, ex: fever, pain, etc)",{"measure":31,"description":32,"timeFrame":33},"Patient Engagement - weekly","Patient engagement will be assessed as the average number of platform accesses per patient per week.","From enrollment to 18 months after surgery",[35],{"measure":36,"description":37,"timeFrame":12},"Satisfaction of physicians","Physician satisfaction will be assessed using the Get Ready Physician Satisfaction Questionnaire (Annex B), consisting of 13 scored items rated from 1 to 10 and 2 open-ended questions. The scored items are summed to obtain a total score ranging from 13 to 130, with higher scores indicating greater physician satisfaction. The open-ended questions are analyzed separately and are not included in the total score.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":6,"observationalModel":38,"timePerspective":38,"maskingInfo":42},"NA","SINGLE_GROUP",{"masking":43,"maskingDescription":38,"whoMasked":38},"NONE","Get Ready™ is a digital solution designed to engage patients throughout their care pathway and to enable remote monitoring of their health status by clinical teams. The solution is built on the Maela® platform, a medical device designed for healthcare professionals to ensure medical follow-up of patients throughout the entire therapeutic journey. This solution enables medical teams and healthcare professionals to define the most appropriate care pathways according to their specialty and the patients treated, and to configure them based on patients' specific needs as well as the operational requirements of clinical centers undergoing a digital transformation process.\n\nThrough the solution, it is possible to:\n\ndigitize protocols related to specific diseases or procedures, based on different types of content (questionnaires, checklists, assigned activities, reminders, educational content, multimedia materials, etc.);\n\nconfigure the care pathway for hospital admission preparation and post-discharge follow-up: protocol-related content is automatically scheduled along the pathway according to key events defined for each patient;\n\nmonitor the patient's health status and adherence to the prescribed pathway;\n\nmanage alerts generated by patient responses to questionnaires or by the failure to complete assigned activities.\n\nThe solution is a cloud-based Software-as-a-Service (SaaS) built on the Maela® digital platform, which does not require any local installation or maintenance and can be used entirely independently of any other corporate IT system.\n\nSystem access is protected by strict control mechanisms and policies based on user profiling, ensuring that each profile can access only the data necessary for its role. Upon request by the hospital, a list of privileges associated with each profile can be provided for review. Users may have only one profile, and the hospital is responsible for managing its own users. Maela is compliant with the GDPR with regard to data processing.\n\nThe solution provides interfaces for both hospital staff and patients:\n\nHealthcare professional interface: a web application for physicians and their teams (nurses, ward staff). User permissions are configurable.\n\nPatient interfaces: a web application and a mobile app (iOS and Android), as well as links to web forms sent via SMS.\n\nSolution administrators and physicians can digitize and configure protocols for any type of care pathway and patient population. Through the web application, healthcare professionals enroll patients into the system, assign applicable protocols, monitor patient participation and adherence to the assigned pathway and protocol, and review and manage alerts. Patients are \"connected\" to their clinical team through a dedicated mobile app (or a web app, if preferred for PC use), which allows them to follow their care pathway and complete assigned activities such as filling in questionnaires, measuring specific parameters, or accessing educational content. Through the app, patients can send documents, images, and photos taken with the mobile device camera to the clinical team-for example, to allow their physician to assess the status of a wound. All documents uploaded to the platform are stored in the patient record and are accessible to authorized healthcare professionals. Patients can also use the app to exchange messages with the care team (and vice versa) and request a callback.\n\nPatient-generated data collected within the system can be attached as reports to the patient's electronic medical record and made available to the multidisciplinary clinical team or other healthcare professionals with authorized access to the patient's data.\n\nThe study primary aims to evaluate whether the use of Get Ready improves remote patient monitoring, optimizes healthcare resources by reducing the number of outpatient visits and surgical procedures cancelled and leads to an improvement in the quality of work of the healthcare staff involved\n\nthe secondary outcomes include:\n\n* To assess the level of satisfaction of physicians using Get Ready by analyzing data from the clinic-specific satisfaction questionnaire, in order to determine whether the solution meets their needs and to identify potential areas for improvement.\n* to evaluate whether the systematic use of the application reduces the number of telephone contacts between the Case Manager and patients, thereby allowing the Case Manager to reallocate the time saved to other activities.\n\nWill be enrolled 500 patients scheduled for bariatric surgery will be enrolled and followed from the beginning of the care pathway (initial visit) through the third postoperative follow-up (18 months after surgery).\"",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"patients using the Get Ready application","EXPERIMENTAL","Patients enrolled in a bariatric surgery care pathway who provide consent to use the Get Ready digital clinical monitoring application.",[51],"Device: app-based clinical monitoring",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":38},"DEVICE","app-based clinical monitoring","The use of a digital clinical monitoring application in patients undergoing surgical care.",[47],[59],{"name":60,"affiliation":61,"role":62},"Vincenzo Bruni, General Surgeon, MD","Fondazione Policlinico Campus Bio-Medico di Roma","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":38,"email":68},"Chiara Isabella Miligi, General Surgeon, MD","CONTACT","+393891015712","c.miligi@policlinicocampus.it",{"name":70,"role":66,"phone":71,"phoneExt":38,"email":72},"Ida Francesca Gallo, General Surgeon, MD","+393926237399","i.gallo@policlinicocampus.it",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Fondazione Policlinico Universitario Campus Bio Medico di Roma","RECRUITING","Rome","RM","00128","Italy","IT",{"type":83,"coordinates":84},"Point",[85,86],12.51133,41.89193,{"lat":86,"lon":85},[89,92],{"name":90,"role":66,"phone":71,"phoneExt":38,"email":91},"IDA FRANCESCA GALLO","I.GALLO@POLICLINICOCAMPUS.IT",{"name":93,"role":66,"phone":38,"phoneExt":38,"email":38},"Ida Francesca Gallo",{"type":95,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[97],{"name":98,"class":99},"Medtronic","INDUSTRY","100657413","get-ready-app-to-monitoring-obesity-patients-before-and-after-bariatric-surgery-100657413",false,"NCT07839624","Get-Ready App to Monitoring Obesity Patients Before and After Bariatric Surgery","Get-Ready: an App for Monitoring Patients With Obesity Before and After Bariatric Surgery. Benefits for Patients and Clinical Team","GRAM","Inclusion Criteria:\n\n* Patients affected by morbid obesity and eligible for bariatric surgery according to SICOB guidelines (aged between 18 and 65 years, inclusive; body mass index \\> 35 kg\u002Fm² with obesity-related comorbidities or BMI \\> 40 kg\u002Fm²)\n\nExclusion Criteria:\n\n* Inability or difficulty in using smartphone or PC applications","ALL","18 Years","65 Years",{"count":112,"type":113},500,"ESTIMATED","INTERVENTIONAL",[40],"The study aims to evaluate whether the use of Get Ready improves remote patient monitoring, streamlines the different phases of the patient pathway, optimizes healthcare resources by reducing the number of outpatient visits and surgical procedures cancelled due to communication difficulties, and leads to an improvement in the quality of work of the healthcare staff involved",[118],"Obesity",[120],"Digital monitoring in Bariatric Surgery","2026-09-21",{"date":123,"type":124},"2026-09-24","ACTUAL",{"date":126,"type":124},"2026-02-01",{"date":128,"type":113},"2029-10-31",{"name":5,"class":6},1]