NCT06879236 Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease
| NCT ID | NCT06879236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | NASH |
| Study Type | OBSERVATIONAL |
| Enrollment | 252 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 252 participants in total. It began in 2025-01-16 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Luca Miele
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06879236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NASH. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06879236 currently recruiting?
Yes, NCT06879236 is actively recruiting participants. Contact the research team at luca.miele@policlinicogemelli.it for enrollment information.
Where is the NCT06879236 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06879236 clinical trial?
NCT06879236 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Luca Miele at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 252 participants.