Evaluation of Remote Monitoring of Liver Cirrhosis Patients

Not yet recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT06746246
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The goal of this longitudinal prospective study is to investigate disease course in patients with liver cirrhosis treated in hospitals that implemented a remote monitoring care pathway as part of their standard liver cirrhosis care pathway.

Participants will be asked to share their medical data and remote monitoring data. Therefore, this study does not contain an intervention.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-02
• Primary Completion: 2040-02
• Study Completion: 2042-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
• Age 18 years or older
• Treated at Gastroenterology department

Exclusion Criteria

• Patients who have declined participation in scientific studies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of liver related complications	From enrollment to the end of follow-up at 15 years, or untill death.	Complications defined as: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.

Secondary Outcome Measures

Name	Time	Method
Number of liver related clinical admissions	From enrollment to the end of follow-up at 15 years, or untill death.	Liver related clinical admissions defined as complications related to: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.
Number of liver related emergency consultations	From enrollment to the end of follow-up at 15 years, or untill death.	Liver related emergency consultations defined as consultations due to: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.
Liver transplantation	From enrollment to the end of follow-up at 15 years, or untill death.
Mortality	From enrollment to the end of follow-up at 15 years.
Number of outpatient department consultations	From enrollment to the end of follow-up at 15 years, or untill death.	Physical or telephone
Number of liver related laboratory tests	From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related radiographic images	From enrollment to the end of follow-up at 15 years, or untill death.
Number of liver related biopsies	From enrollment to the end of follow-up at 15 years, or untill death.
Percentage of completed modules in remote monitoring sessions	From enrollment to the end of follow-up at 15 years, or untill death.