Digital prevention for liver disease management
Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease
This study is testing a new way to help people with liver disease by using a mobile app for patients and a dashboard for doctors to see if it improves their care and health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06879236 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, metabolic dysfunction-associated steatohepatitis (MASH). It aims to develop a new model of care that combines standard clinical procedures with a digital approach, utilizing a mobile application for patients and a clinical dashboard for healthcare professionals. The study will collect and analyze clinical data, including anthropometric, laboratory, and imaging data, to enhance early detection and management of MASLD. The goal is to improve patient outcomes through better monitoring and support.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with MASLD who have sufficient digital literacy or support.
Not a fit: Patients with major psychiatric disorders or those unable to use digital technologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and improved management of liver diseases, potentially reducing the risk of severe complications.
How similar studies have performed: While there is limited information on similar digital interventions specifically for MASLD, the integration of digital health tools in chronic disease management has shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with MASLD and LSM\>= 10 kPa * Age \>= 18 years old * Sufficient digital literacy or supported from a caregiver with sufficient digital literacy * Smartphone (Android or iOS) able to download and run the App * Able to understand and communicate in Italian * Able to sign the informed consent Exclusion Criteria: * Major psychiatric disorder * Not able to use digital technologies
Where this trial is running
Rome, Lazio
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Miele — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Luca Miele
- Email: luca.miele@policlinicogemelli.it
- Phone: +390630155701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.