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NCT Number: NCT06746246

Evaluation of Remote Monitoring of Liver Cirrhosis Patients

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of liver related complications

    Time frame: 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 outcomes

  1. Number of liver related clinical admissions

    Time frame: 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.

  2. Number of liver related emergency consultations

    Time frame: 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.

  3. Liver transplantation

    Time frame: From enrollment to the end of follow-up at 15 years, or untill death.

  4. Mortality

    Time frame: From enrollment to the end of follow-up at 15 years.

  5. Number of outpatient department consultations

    Time frame: From enrollment to the end of follow-up at 15 years, or untill death.

    Physical or telephone

  6. Number of liver related laboratory tests

    Time frame: From enrollment to the end of follow-up at 15 years, or untill death.

  7. Number of liver related radiographic images

    Time frame: From enrollment to the end of follow-up at 15 years, or untill death.

  8. Number of liver related biopsies

    Time frame: From enrollment to the end of follow-up at 15 years, or untill death.

  9. Percentage of completed modules in remote monitoring sessions

    Time frame: From enrollment to the end of follow-up at 15 years, or untill death.

Other outcomes

  1. 5-level EuroQol-5 Dimensions scores

    Time frame: From enrollment to the end of follow-up at 15 years, or untill death.

    5-level EQ-5D version (EQ-5D-5L). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

Study contacts

Contact information is provided by the study sponsor or research team.

Britt van Ruijven, MD

CONTACT

[email protected]

+31883887470

Tom Gevers, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Albert Schweitzer Hospital
  • Gelre Hospitals
  • Jeroen Bosch Ziekenhuis
  • Noordwest Ziekenhuisgroep

Registry information

Official study title

Prospective Evaluation of Multicenter Implementation of Remote Monitoring of Liver Cirrhosis Patients

Important dates

Study start
2026
Primary completion
2040
Study completion
2042
First posted
Dec 24, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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