ObesityGRAMNCT07839624
Get-Ready App to Monitoring Obesity Patients Before and After Bariatric Surgery
A study testing app-based clinical monitoring in people with Obesity, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- app-based clinical monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2026to 31 Oct 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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/m² with obesity-related comorbidities or BMI > 40 kg/m²)
Who cannot join
- Inability or difficulty in using smartphone or PC applications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Campus Bio Medico di Roma
Rome, RM, 00128
IDA FRANCESCA GALLO, +393926237399, I.GALLO@POLICLINICOCAMPUS.IT
Ida Francesca Gallo
About this study
Official title: Get-Ready: an App for Monitoring Patients With Obesity Before and After Bariatric Surgery. Benefits for Patients and Clinical Team
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
Read the detailed description
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:
- 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.
- 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.
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)."
- Conditions
- Obesity
- Being tested
- app-based clinical monitoring
- Keywords
- Digital monitoring in Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
app-based clinical monitoringDevice
The use of a digital clinical monitoring application in patients undergoing surgical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: app-based clinical monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: From enrollment to 18 months after surgery
Secondary outcomes (1)
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.
Measured: From enrollment to the end of bariatric follow up at 18 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Feb 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Vincenzo Bruni, General Surgeon, MD, Principal investigator, Fondazione Policlinico Campus Bio-Medico di Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839624
- Sponsor's protocol ID
- GRAM-1
- Acronym
- GRAM
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No