Clinical trial NCT06746246: Evaluation of Remote Monitoring of Liver Cirrhosis Patients
Official title: Prospective Evaluation of Multicenter Implementation of Remote Monitoring of Liver Cirrhosis Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Cirrhosis
Keywords: Digital health
Remote monitoring
eHealth
mHealth
Telehealth
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Gelre Hospitals
name: Noordwest Ziekenhuisgroep
name: Jeroen Bosch Ziekenhuis
name: Albert Schweitzer Hospital
First posted: 2024-12-24
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


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.

Primary outcomes:
measure: Number of liver related complications
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
Secondary outcomes:
measure: Number of liver related clinical admissions
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
measure: Number of liver related emergency consultations
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
measure: Liver transplantation
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
measure: Mortality
timeFrame: From enrollment to the end of follow-up at 15 years.
measure: Number of outpatient department consultations
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
measure: Number of liver related laboratory tests
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
measure: Number of liver related radiographic images
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
measure: Number of liver related biopsies
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
measure: Percentage of completed modules in remote monitoring sessions
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
Other outcomes:
measure: 5-level EuroQol-5 Dimensions scores
timeFrame: From enrollment to the end of follow-up at 15 years, or untill death.
Locations:
Study officials:
affiliation: Maastricht University Medical Center
name: Tom Gevers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.