Evaluation of Remote Monitoring of Liver Cirrhosis Patients

Maastricht University Medical Centre (MUMC)

Status: Begins enrollment in 2 months

Conditions: Liver Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT06746246

2024-0284

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

750 participants in 2 patient groups

1. Standard care with remote monitoring

Description:

Liver cirrhosis patients participating in remote monitoring as part of new standard care pathway. They will give digital consent after subscription to the remote monitoring platform. Retrospective and prospective data will be gathered. Follow-up lasts 15 years, or until death. Patients participating in remote monitoring can be approached to give feedback about remote monitoring in terms of satisfaction, usability, applicability, compliance and feasibility.

Standard care without remote monitoring

Description:

Liver cirrhosis patients not participating in remote monitoring. They will not be approached for informed consent and give implicit consent for data gathering unless otherwise stated in their individual electronic patient record. Retrospective and prospective data will be gathered. Follow-up lasts 15 years, or until death.