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

Recruiting

• Conditions: NASH; NAFLD

• Registration Number: NCT06879236
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-26
• Study Start: 2025-01-16
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-02-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
App Adherence (>80% over 4 weeks)	4 weeks	Assessed via smartphone (number of app access)

Secondary Outcome Measures

Name	Time	Method
Weight reduction assessment	12 month	Number of subjects with a 12-month reduction between 7-10% of weight compared to baseline
Change in liver and spleen stiffness	Baseline, after 4 weeks and 12 month	Assessed by transient elastography
Change in Patient Reported Outcome questionnaire	12 weeks	Evaluation of overall physical well-being through the administration of questionnaires
Changes in measure energy expenditure	12 month	Cycle ergometer
Microbiome signature	12 month	Analysis of microbiome signature from feces
Clinical events	12 month	Record of number of hospitalization, decompensation, variceal bleeding, encephalopathy, ascites, liver cancer, liver transplantation, death

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD; 🇮🇹 Roma, Lazio, Italy