Liver Cirrhosis
Conditions
Keywords
Digital health, Remote monitoring, eHealth, mHealth, Telehealth
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.
Interventions
None listed
Sponsors
Gelre Hospitals
Noordwest Ziekenhuisgroep
Jeroen Bosch Ziekenhuis
Albert Schweitzer Hospital
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of liver related complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of liver related biopsies | From enrollment to the end of follow-up at 15 years, or untill death. | — |
| Number of liver related laboratory tests | From enrollment to the end of follow-up at 15 years, or untill death. | — |
| Number of liver related radiographic images | 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 related emergency consultations defined as consultations due to: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy. |
| Number of liver related clinical admissions | 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. |
| 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. | Physical or telephone |
| Percentage of completed modules in remote monitoring sessions | 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. | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 5-level EuroQol-5 Dimensions scores | 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. |
Contacts
Primary ContactBritt van Ruijven, MD
Backup ContactTom Gevers, MD, PhD
Outcome results
None listed