Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD
Rome, Lazio, 00168, Italy
Location status: Recruiting
NCT Number: NCT06879236
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rome, Lazio, 00168, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 weeks
Assessed via smartphone (number of app access)
Time frame: 12 month
Number of subjects with a 12-month reduction between 7-10% of weight compared to baseline
Time frame: Baseline, after 4 weeks and 12 month
Assessed by transient elastography
Time frame: 12 weeks
Evaluation of overall physical well-being through the administration of questionnaires
Time frame: 12 month
Cycle ergometer
Time frame: 12 month
Analysis of microbiome signature from feces
Time frame: 12 month
Record of number of hospitalization, decompensation, variceal bleeding, encephalopathy, ascites, liver cancer, liver transplantation, death
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Acronym: CALIBRE
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.
Published trials that share one or more normalized conditions with this study.
NCT06588699
Digestive System Diseases, Fatty Liver
New Haven, Connecticut, United States
View Trial DetailsNCT06124261
Digestive System Diseases, Fatty Liver
San Francisco, California, United States
View Trial DetailsNCT06888310
Digestive System Diseases, Fatty Liver
Roma, Italy
View Trial DetailsNCT06308757
Body Weight, Digestive System Diseases
Bologna, Italy
View Trial Details