AI-ACLD Study: Artificial Intelligence in Advanced Chronic Liver Disease.
Descrizione riassuntiva dello studio
The research project studies the possibility of using an artificial intelligence-based system in patients with advanced chronic liver disease (liver cirrhosis) to record variations in a patient's health status, with the aim of early identification of clinical improvement or deterioration. We want to know if the use of this system, which is based on the recording and processing of various clinical parameters using an Apple Watch, can correlate with the clinical evolution of the patient and ultimately be able to improve care management and quality of life.
(BASEC)
Intervento studiato
we will use an Apple Watch to specifically monitor patients with liver cirrhosis, who will wear it for the period specified by the study. Patients hospitalized for a complication of cirrhosis will then be continuously monitored with the Apple Watch from the time of admission until discharge. During part B of the study, for which a separate informed consent document is provided, patients with cirrhosis followed in an outpatient setting will be included, who will be continuously monitored with the Apple Watch for a total of 6 months. The patient included in part A of the study may, if desired, continue their participation in part B of the study from the time of discharge for the following 6 months.
(BASEC)
Malattie studiate
advanced chronic liver disease (liver cirrhosis)
(BASEC)
Inclusion criteria, part A: all patients aged between 18 and 75 years with ACLD hospitalized at the Cantonal Hospital (EOC) of Lugano or Bellinzona, Switzerland for symptoms of hepatic decompensation or acute or chronic liver failure. These include ascites, hepatorenal syndrome, hepatic encephalopathy, bacterial infection, gastrointestinal bleeding, or jaundice. Inclusion criteria, part B: all patients aged between 18 and 75 years with ACLD and Child-Pugh B cirrhosis followed at our Department of Gastroenterology and Hepatology, Cantonal Hospital will be evaluated for inclusion in the study. (BASEC)
Criteri di esclusione
Exclusion criteria, part A: patients who are unable or refuse to give written informed consent; patients who are unable to wear and/or properly use the device; patients with hepatocellular carcinoma beyond the Milan criteria (a lesion up to 5 cm or 3 lesions up to 3 cm in diameter). Exclusion criteria, part B: patients who are unable or refuse to give written informed consent; patients who are unable to wear and/or properly use the device; presence of any decompensation or ACLF. (BASEC)
Luogo dello studio
Bellinzona, Lugano
(BASEC)
Sponsor
Ospedale Regionale di Lugano
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Andrea De Gottardi
+4191 811 76 36
Andrea.DeGottardi@cluttereoc.chServizio di Gastroenterologia ed Epatologia Ospedale Regionale di Lugano
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ticino
(BASEC)
Data di approvazione del comitato etico
29.08.2022
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Application of artificial intelligence using wearable technology in patients with advanced chronic liver disease (ACLD): a trajectomics approach. (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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