About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Major psychiatric disorder
Not able to use digital technologies
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
App Adherence (>80% over 4 weeks)
Assessed via smartphone (number of app access)
Secondary outcomes
Weight reduction assessment
Number of subjects with a 12-month reduction between 7-10% of weight compared to baseline
Change in liver and spleen stiffness
Assessed by transient elastography
Change in Patient Reported Outcome questionnaire
Evaluation of overall physical well-being through the administration of questionnaires
Changes in measure energy expenditure
Cycle ergometer
Sponsors and contacts
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