Get-Ready: an App for Monitoring Patients With Obesity Before and After Bariatric Surgery. Benefits for Patients and Clinical Team
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Protocol Adherence
研究概览
简要总结
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
详细描述
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;
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Inability or difficulty in using smartphone or PC applications
研究组 & 干预措施
patients using the Get Ready application
Patients enrolled in a bariatric surgery care pathway who provide consent to use the Get Ready digital clinical monitoring application.
干预措施: app-based clinical monitoring (Device)
结局指标
主要结局
Protocol Adherence
时间窗: From enrollment to the end of bariatric follow up at 18 month after surgery
Protocol adherence will be assessed as the percentage of enrolled patients who complete the study protocol.
Patient Adoption
时间窗: From enrollment to the end of bariatric follow up at 18 month after surgery
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.
Patient's satisfaction with the digital platform
时间窗: 180 days after discharge
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.
Healthcare Professional platform use
时间窗: From enrollment to 18 month after surgery
Healthcare professional platform use will be assessed as the average number of logins per healthcare professional per week.
Alert Management: alert volume
时间窗: From enrollment to the end of bariatric follow up at 18 month after surgery
* 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
Alert Management: Types of Alerts Generated
时间窗: From enrollment to the end of bariatric follow up at 18 month after surgery
Will be collected the Type of alerts (n./%, clinical or administrative) and type of clinical alerts (n./%, ex: fever, pain, etc)
Patient Engagement - weekly
时间窗: From enrollment to 18 months after surgery
Patient engagement will be assessed as the average number of platform accesses per patient per week.
次要结局
- Satisfaction of physicians(From enrollment to the end of bariatric follow up at 18 month after surgery)