Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Have a major psychiatric disorder
- Unable to use digital technologies
AI-Screening
AI-Powered Screening
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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
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
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