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| Name | Class |
|---|---|
| Gelre Hospitals | OTHER |
| Noordwest Ziekenhuisgroep | OTHER |
| Jeroen Bosch Ziekenhuis | OTHER |
| Albert Schweitzer Hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of liver related clinical admissions | 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. | From enrollment to the end of follow-up at 15 years, or untill death. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-level EuroQol-5 Dimensions scores | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Patients of 18 years and older with a liver cirrhosis diagnosis, treated at a Gastroenterology department in one of the participating centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Britt van Ruijven, MD | Contact | +31883887470 | britt.vanruijven@maastrichtuniversity.nl | |
| Tom Gevers, MD, PhD | Contact | tom.gevers@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Tom Gevers, MD, PhD | Maastricht University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28618192 | Background | 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. | |
| 36087864 |
| Label | URL |
|---|---|
| Foundation for collaborative development of e-Health tools for different chronic diseases. | View source |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| OTHER |
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| Number of liver related emergency consultations | 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. | 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 | Physical or telephone | 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 biopsies | From enrollment to the end of follow-up at 15 years, or untill death. |
| Percentage of completed modules in remote monitoring sessions | From enrollment to the end of follow-up at 15 years, or untill death. |
| From enrollment to the end of follow-up at 15 years, or untill death. |
| Background |
| 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. |
| 28716313 | Background | 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. |
| 34863359 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |