NCT06746246

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
192mo left

Started May 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2040

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2042

Last Updated

September 26, 2025

Status Verified

December 1, 2024

Enrollment Period

13.8 years

First QC Date

December 5, 2024

Last Update Submit

September 25, 2025

Conditions

Liver Cirrhosis

Keywords

Digital healthRemote monitoringeHealthmHealthTelehealth

Outcome Measures

Primary Outcomes (1)

  • Number of liver related complications

    Complications defined as: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.

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

Secondary Outcomes (9)

  • Number of liver related clinical admissions

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

  • Number of liver related emergency consultations

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

  • 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.

  • +4 more secondary outcomes

Other Outcomes (1)

  • 5-level EuroQol-5 Dimensions scores

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

Study Arms (2)

1. Standard care with remote monitoring

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

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of 18 years and older with a liver cirrhosis diagnosis, treated at a Gastroenterology department in one of the participating centers.

You may qualify if:

  • Age 18 years or older
  • Treated at Gastroenterology department

You may not qualify if:

  • Patients who have declined participation in scientific studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ganapathy D, Acharya C, Lachar J, Patidar K, Sterling RK, White MB, Ignudo C, Bommidi S, DeSoto J, Thacker LR, Matherly S, Shaw J, Siddiqui MS, Puri P, Sanyal AJ, Luketic V, Lee H, Stravitz RT, Bajaj JS. The patient buddy app can potentially prevent hepatic encephalopathy-related readmissions. Liver Int. 2017 Dec;37(12):1843-1851. doi: 10.1111/liv.13494. Epub 2017 Jul 5.

    PMID: 28618192BACKGROUND

  • Kazankov K, Novelli S, Chatterjee DA, Phillips A, Balaji A, Raja M, Foster G, Tripathi D, Boddu R, Kumar R, Jalan R, Mookerjee RP. Evaluation of CirrhoCare(R) - a digital health solution for home management of individuals with cirrhosis. J Hepatol. 2023 Jan;78(1):123-132. doi: 10.1016/j.jhep.2022.08.034. Epub 2022 Sep 8.

    PMID: 36087864BACKGROUND

  • de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, Becx MC, Maljaars JP, Cilissen M, van Bodegraven AA, Mahmmod N, Markus T, Hameeteman WM, Dijkstra G, Masclee AA, Boonen A, Winkens B, van Tubergen A, Jonkers DM, Pierik MJ. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-968. doi: 10.1016/S0140-6736(17)31327-2. Epub 2017 Jul 14.

    PMID: 28716313BACKGROUND

  • Karlsen TH, Sheron N, Zelber-Sagi S, Carrieri P, Dusheiko G, Bugianesi E, Pryke R, Hutchinson SJ, Sangro B, Martin NK, Cecchini M, Dirac MA, Belloni A, Serra-Burriel M, Ponsioen CY, Sheena B, Lerouge A, Devaux M, Scott N, Hellard M, Verkade HJ, Sturm E, Marchesini G, Yki-Jarvinen H, Byrne CD, Targher G, Tur-Sinai A, Barrett D, Ninburg M, Reic T, Taylor A, Rhodes T, Treloar C, Petersen C, Schramm C, Flisiak R, Simonova MY, Pares A, Johnson P, Cucchetti A, Graupera I, Lionis C, Pose E, Fabrellas N, Ma AT, Mendive JM, Mazzaferro V, Rutter H, Cortez-Pinto H, Kelly D, Burton R, Lazarus JV, Gines P, Buti M, Newsome PN, Burra P, Manns MP. The EASL-Lancet Liver Commission: protecting the next generation of Europeans against liver disease complications and premature mortality. Lancet. 2022 Jan 1;399(10319):61-116. doi: 10.1016/S0140-6736(21)01701-3. Epub 2021 Dec 2. No abstract available.

    PMID: 34863359BACKGROUND

Related Links

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tom Gevers, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Britt van Ruijven, MD

CONTACT

+31883887470britt.vanruijven@maastrichtuniversity.nl

Tom Gevers, MD, PhD

CONTACT

tom.gevers@mumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 24, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

February 1, 2040

Study Completion (Estimated)

February 1, 2042

Last Updated

September 26, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share