Digital prevention for liver disease management
Official title: Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06879236 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 252 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Status | Recruiting |
| Started | January 16, 2025 |
| Main results expected | December 14, 2026 |
| Study ends | January 1, 2028 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT06879236 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with MASLD who have sufficient digital literacy or support.
✕Probably not a fit
Patients with major psychiatric disorders or those unable to use digital technologies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
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This study is collecting health information and samples from people with Non-Alcoholic Fatty Liver Disease to learn more about the disease and find better ways to track its progress.
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This project tests whether blood tests and imaging scans can diagnose and stage metabolic-associated steatohepatitis (MASH) and liver fibrosis in adults with metabolic risk factors.
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This tests whether taking daily low‑methoxy pectin for six weeks can reduce inflammation and improve gut bacteria and metabolic markers in adults with MASLD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.