Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment252 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Locations1 site (Rome, Lazio)
StatusRecruiting
StartedJanuary 16, 2025
Main results expectedDecember 14, 2026
Study endsJanuary 1, 2028
Registry record updatedSeptember 17, 2026
Trial IDNCT06879236 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

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD
    Rome, Lazio, Italy
    Recruiting

Study contacts

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.