An interventional study of app-based clinical monitoring in Obesity, sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Fondazione Policlinico Universitario Campus Bio-Medico · Not applicable, Interventional, and Other
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
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.
Through the solution, it is possible to:
digitize protocols related to specific diseases or procedures, based on different types of content (questionnaires, checklists, assigned activities, reminders, educational content, multimedia materials, etc.);
configure 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;
monitor the patient's health status and adherence to the prescribed pathway;
manage alerts generated by patient responses to questionnaires or by the failure to complete assigned activities.
The 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.
System 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.
The solution provides interfaces for both hospital staff and patients:
Healthcare professional interface: a web application for physicians and their teams (nurses, ward staff). User permissions are configurable.
Patient interfaces: a web application and a mobile app (iOS and Android), as well as links to web forms sent via SMS.
Solution 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.
Patient-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.
The 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
the secondary outcomes include:
Will 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)."
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 500 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Fondazione Policlinico Universitario Campus Bio-Medico is the lead sponsor of 29 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients enrolled in a bariatric surgery care pathway who provide consent to use the Get Ready digital clinical monitoring application.
Device: app-based clinical monitoring
The use of a digital clinical monitoring application in patients undergoing surgical care.
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.
Time frame: From enrollment to the end of bariatric follow up at 18 month after surgery
Protocol Adherence
Protocol adherence will be assessed as the percentage of enrolled patients who complete the study protocol.
Time frame: From enrollment to the end of bariatric follow up at 18 month after surgery
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.
Time frame: 180 days after discharge
Healthcare Professional platform use
Healthcare professional platform use will be assessed as the average number of logins per healthcare professional per week.
Time frame: From enrollment to 18 month after surgery
Alert Management: alert volume
* Number of alerts * Number of alerts per patient * Number of alerts per patient group (e.g. age, time within the care pathway, etc.) * Number of postoperative alerts
Time frame: From enrollment to the end of bariatric follow up at 18 month after surgery
Alert Management: Types of Alerts Generated
Will be collected the Type of alerts (n./%, clinical or administrative) and type of clinical alerts (n./%, ex: fever, pain, etc)
Time frame: From enrollment to the end of bariatric follow up at 18 month after surgery
Patient Engagement - weekly
Patient engagement will be assessed as the average number of platform accesses per patient per week.
Time frame: From enrollment to 18 months after surgery
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.
Time frame: From enrollment to the end of bariatric follow up at 18 month after surgery
Plan to share: No
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Fondazione Policlinico Universitario Campus Bio-Medico