Health TrialsbyHealthPanel

Get-Ready App to Monitoring Obesity Patients Before and After Bariatric Surgery

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFondazione Policlinico Universitario Campus Bio-Medico

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Inability or difficulty in using smartphone or PC applications

Trial design

Design model

Single group

Treatments tested in this trial

  • app-based clinical monitoring

    Device

    The use of a digital clinical monitoring application in patients undergoing surgical care.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: patients using the Get Ready applicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

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.

Time frame
From enrollment to the end of bariatric follow up at 18 month after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Campus Bio-Medico

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov
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