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Not yet recruiting NCT06746246

Evaluation of Remote Monitoring of Liver Cirrhosis Patients

— Observational Liver Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liver Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Number of liver related complications [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
Secondary outcome measures (9)
  • Number of liver related clinical admissions [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
  • Number of liver related emergency consultations [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
  • Liver transplantation [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
  • Mortality [Time frame: From enrollment to the end of follow-up at 15 years.]
  • Number of outpatient department consultations [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
  • Number of liver related laboratory tests [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
  • Number of liver related radiographic images [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
  • Number of liver related biopsies [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]
  • Percentage of completed modules in remote monitoring sessions [Time frame: From enrollment to the end of follow-up at 15 years, or untill death.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 28618192
  • 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 36087864
  • 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: PMID 28716313
  • 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 PMID 34863359

Identifiers

NCT: NCT06746246 · 2024-0284

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗