AI-ACLD Study: Artificial Intelligence in Advanced Chronic Liver Disease.
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Bellinzona, Lugano
(BASEC)
Sponsor
Ospedale Regionale di Lugano
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Andrea De Gottardi
+4191 811 76 36
Andrea.DeGottardi@cluttereoc.chServizio di Gastroenterologia ed Epatologia Ospedale Regionale di Lugano
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Tessin
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.08.2022
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Application of artificial intelligence using wearable technology in patients with advanced chronic liver disease (ACLD): a trajectomics approach. (BASEC)
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ein-/Ausschlusskriterien
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Ergebnisse der Studie
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