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OpenTrials
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NCT Number: NCT06879236

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Luca Miele

CONTACT

[email protected]

+390630155701

Luca Miele

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. App Adherence (>80% over 4 weeks)

    Time frame: 4 weeks

    Assessed via smartphone (number of app access)

Secondary outcomes

  1. Weight reduction assessment

    Time frame: 12 month

    Number of subjects with a 12-month reduction between 7-10% of weight compared to baseline

  2. Change in liver and spleen stiffness

    Time frame: Baseline, after 4 weeks and 12 month

    Assessed by transient elastography

  3. Change in Patient Reported Outcome questionnaire

    Time frame: 12 weeks

    Evaluation of overall physical well-being through the administration of questionnaires

  4. Changes in measure energy expenditure

    Time frame: 12 month

    Cycle ergometer

  5. Microbiome signature

    Time frame: 12 month

    Analysis of microbiome signature from feces

  6. Clinical events

    Time frame: 12 month

    Record of number of hospitalization, decompensation, variceal bleeding, encephalopathy, ascites, liver cancer, liver transplantation, death

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Miele

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: CALIBRE

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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