Идёт набор NCT06879236

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

— Наблюдательное NASH NAFLD

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: NASH, NAFLD. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Первичные конечные точки

App Adherence (>80% over 4 weeks) [Срок оценки: 4 weeks]

Вторичные конечные точки (6)

Weight reduction assessment [Срок оценки: 12 month]
Change in liver and spleen stiffness [Срок оценки: Baseline, after 4 weeks and 12 month]
Change in Patient Reported Outcome questionnaire [Срок оценки: 12 weeks]
Changes in measure energy expenditure [Срок оценки: 12 month]
Microbiome signature [Срок оценки: 12 month]
Clinical events [Срок оценки: 12 month]

Критерии участия

Критерии включения

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