AI-ACLD Study: Artificial Intelligence in Advanced Chronic Liver Disease.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Bellinzona, Lugano
(BASEC)
Sponsor
Ospedale Regionale di Lugano
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Andrea De Gottardi
+4191 811 76 36
Andrea.DeGottardi@cluttereoc.chServizio di Gastroenterologia ed Epatologia Ospedale Regionale di Lugano
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Tessin
(BASEC)
Date d'approbation du comité d'éthique
29.08.2022
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Application of artificial intelligence using wearable technology in patients with advanced chronic liver disease (ACLD): a trajectomics approach. (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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