Clinical trial NCT06879236: Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease
Official title: Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NASH
NAFLD
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects with type 2 diabetes and/or metabolic syndrome and/or dyslipidemia and/or obesity (BMI\>30 Kg/m2) and/or familiar history for cirrhosis or liver cancer in the absence of known risk factors

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).


Eligibility 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

Primary outcomes:
measure: App Adherence (>80% over 4 weeks)
timeFrame: 4 weeks
Secondary outcomes:
measure: Weight reduction assessment
timeFrame: 12 month
measure: Change in liver and spleen stiffness
timeFrame: Baseline, after 4 weeks and 12 month
measure: Change in Patient Reported Outcome questionnaire
timeFrame: 12 weeks
measure: Changes in measure energy expenditure
timeFrame: 12 month
measure: Microbiome signature
timeFrame: 12 month
measure: Clinical events
timeFrame: 12 month
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Luca Miele
role: PRINCIPAL_INVESTIGATOR
References: