Actively Recruiting

Age: 18Years +
All Genders
NCT06879236

Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-17

252

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, Metabolic dysfunction-associated steatohepatitis (MASH), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (HCC), and the need for liver transplantation. Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced. Currently, the treatment options MASLD are limited to lifestyle interventions such as dietary changes and physical activity. Despite the increasing prevalence of MASLD, there are no drugs available on the market specifically for this condition. The goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (HCPs), integrated with simple clinical data (anthropometric, laboratory and imaging data). This study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced MASLD at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease. To achieve this goal the study will leverage on a mobile app named OpenTele in order to test the adherence to lifestyle changes in patient with MASLD and on the connected clinical dashboard. The app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims: * to implement a strategy for delay progression of liver disease; * to reduce the effect of cirrhosis (tertiary prevention).

CONDITIONS

Official Title

Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with MASLD and LSM>= 10 kPa
  • Age 18 years or older
  • Have sufficient digital literacy or support from a caregiver with digital literacy
  • Own a smartphone (Android or iOS) capable of running the app
  • Able to understand and communicate in Italian
  • Able to sign the informed consent
Not Eligible

You will not qualify if you...

  • Have a major psychiatric disorder
  • Unable to use digital technologies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD

Rome, Lazio, Italy, 00168

Actively Recruiting

Loading map...

Research Team

L

Luca Miele

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here