Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundation of Ester Ã…sberg-Lindbergs memories, Falun; Sweden | UNKNOWN |
| Center for Clinical Research Dalarna, Sweden | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study compare the effects of traditional follow-up by physician with a combined follow-up alternately by physician and nurse-led clinic. The main variable is; health related quality of Life. Participants are randomized into control group or intervention group.
The incidence of liver cirrhosis in Sweden increase mostly due to life style factors. A large need of care is common in the end stage of the disease. Nurse-led clinics for other groups of patients, e.g. coronary heart disease, have shown high quality which has resulted in an established part of the follow-up.
This study is a randomized controlled study at six Swedish hospitals to study the effect of a changed follow-up process for liver cirrhotic patients by adding a nurse-led clinic to follow up by physician. The intervention implies a larger extend of nursing interventions at the outpatient clinic to increase the patient's quality of life, quality of care and reduce the need of inpatient care.
A few hospitals in Sweden offers a nurse-led clinic for liver cirrhotic patients, the interest in other hospitals are raising. Though there is a lack of evidence in nursing intervention within this population and it is still unknown what the effects are for the individual or on the health economy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (CI) | Experimental | Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors. |
|
| Control (CC) | No Intervention | Compensated Control (CC) | |
| Intervention (DI) | Experimental | Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs |
|
| Control (DC) | No Intervention | Decompensated Control (DC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risk factors | Other | monitoring risk factors due to deterioration of the liver disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Health related quality of life | Patient survey using the instrument from Research and development, RAND 36-item heath survey | At baseline after 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical examination of presence of ascites | Severity of ascites is grouped as none, mild or severe | At baseline after 12 and 24 months |
| Child-Pugh scale | Liver cirrhosis specific calculator to measure long time survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lars Rönnblom, Professor | Dept of Medical Sciencies, Uppsala University, Uppsala, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology department | Falun | 791 82 | Sweden | |||
| Gastroenterology outpatientclinic, Sahlgrenska hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12924658 | Background | Arguedas MR, DeLawrence TG, McGuire BM. Influence of hepatic encephalopathy on health-related quality of life in patients with cirrhosis. Dig Dis Sci. 2003 Aug;48(8):1622-6. doi: 10.1023/a:1024784327783. | |
| 26226019 | Background | Abdi F, Daryani NE, Khorvash F, Yousefi Z. Experiences of Individuals With Liver Cirrhosis: A Qualitative Study. Gastroenterol Nurs. 2015 Jul-Aug;38(4):252-7. doi: 10.1097/SGA.0000000000000122. |
| Label | URL |
|---|---|
| Practice Guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. (2014). Hepatic encephalopathy in chronic liver disease. | View source |
Not provided
The data that support the findings of this study are available from Region Dalarna upon reasonable request, provided that the data can be made available in accordance with applicable data protection and privacy regulations.
Contact information: Maria Hjorth, maria.hjorth@regiondalarna.se and diariet@regiondalarna.se
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2025 | |
| Reset | Dec 3, 2025 | |
| Release | Jan 12, 2026 | |
| Reset | Jan 28, 2026 | |
| Release | Apr 17, 2026 | |
| Reset | May 8, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 8, 2018 | Jan 21, 2019 | Prot_SAP_ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2025 | Dec 3, 2025 | |||
| Jan 12, 2026 |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D012307 | Risk Factors |
| D012648 | Self Care |
| D009752 | Nutritional Status |
| D057184 | Practice Patterns, Nurses' |
| ID | Term |
|---|---|
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| self-care | Other | information and motivation to adherence to self-care instructions and medical treatment |
|
| nutrition | Other | nutritional assessment and activities to prevent malnutrition |
|
| lifestyle | Other | motivation of lifestyle changes essential for disease progress and |
|
| psychosocial needs | Other | psychosocial care. |
|
| Nurse-led clinic | Other | compensated disease once yearly, decompensated disease twice a month to every third month |
|
| At baseline after 12 and 24 months |
| Presence of Hepatic encephalopathy | Paper and pencil test the psychometric hepatic encephalopathy score (PHES) | At baseline after 12 and 24 months |
| Health literacy | Standardized interview of a table of contents using the instrument The newest vital sign (NVS) | At baseline after 12 and 24 months |
| Model of end stage liver disease (MELD-score) | A liver cirrhosis specific calculator to assess short time survival rate | At baseline after 12 and 24 months |
| Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool | A liver cirrhosis specific instrument will be used to assess the risk of malnutrition. The risk is subdivided into low, moderate or high risk. | At baseline after 12 and 24 months |
| Changes in patients experienced Quality of care | Patient survey using the instrument Quality of care from the the patient's perspective (QPP) | At baseline after 12 and 24 months |
| Health care consumption | Medical Review of inpatient and outpatient care | through study completion, 24 months |
| Gothenburg |
| 41345 |
| Sweden |
| Gastroenterology outpatient department, Skane Universityhospital | Malmö | 20502 | Sweden |
| Gastroenterology department, Örebro Universityhospital | Örebro | 701 85 | Sweden |
| Gastroenterology department, Danderyd hospital | Stockholm | 182 88 | Sweden |
| Gastroenterology department, Uppsala academical hospital | Uppsala | 751 85 | Sweden |
| 16911172 | Background | Arvidsson SB, Petersson A, Nilsson I, Andersson B, Arvidsson BI, Petersson IF, Fridlund B. A nurse-led rheumatology clinic's impact on empowering patients with rheumatoid arthritis: A qualitative study. Nurs Health Sci. 2006 Sep;8(3):133-9. doi: 10.1111/j.1442-2018.2006.00269.x. |
| 24612294 | Background | Biddle ML, Adler NR, Heath M, Streat S, Wardrop M, Watson JP. Nurse-led clinic: effective and efficient delivery of assessment and review of patients with hepatitis B and C. Intern Med J. 2014 Jun;44(6):581-5. doi: 10.1111/imj.12400. |
| 23006457 | Background | Bleibel W, Al-Osaimi AM. Hepatic encephalopathy. Saudi J Gastroenterol. 2012 Sep-Oct;18(5):301-9. doi: 10.4103/1319-3767.101123. |
| 26725059 | Background | Borhofen SM, Gerner C, Lehmann J, Fimmers R, Gortzen J, Hey B, Geiser F, Strassburg CP, Trebicka J. The Royal Free Hospital-Nutritional Prioritizing Tool Is an Independent Predictor of Deterioration of Liver Function and Survival in Cirrhosis. Dig Dis Sci. 2016 Jun;61(6):1735-43. doi: 10.1007/s10620-015-4015-z. Epub 2016 Jan 2. |
| 21389250 | Background | Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9. |
| Background | Chaney A, Werner KT & Kipple T. Primary care management of hepatic encephalopathy: A common cirrhosis complication. The journal for Nurse Practisioners. 11(3): 300-306, 2015. |
| 22154095 | Background | Disler RT, Gallagher RD, Davidson PM. Factors influencing self-management in chronic obstructive pulmonary disease: an integrative review. Int J Nurs Stud. 2012 Feb;49(2):230-42. doi: 10.1016/j.ijnurstu.2011.11.005. Epub 2011 Dec 6. |
| 18437067 | Background | Evangelista LS, Shinnick MA. What do we know about adherence and self-care? J Cardiovasc Nurs. 2008 May-Jun;23(3):250-7. doi: 10.1097/01.JCN.0000317428.98844.4d. |
| 11491194 | Background | Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089. |
| Background | Hommel A, Idvall E & Andersson AC. Kvalitetsutveckling: Kvalitet och omvårdnad. I AK Edberg, A Ehrenberg, F Friberg, L Wallin, H Wijk & J Öhlén (Eds) Omvårdnad på avancerad nivå: Kärnkompetenser inom sjuksköterskans specialistområden (1st ed, pp. 147-150), 2013. |
| 8275167 | Background | Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305. |
| 3610046 | Background | Infante-Rivard C, Esnaola S, Villeneuve JP. Clinical and statistical validity of conventional prognostic factors in predicting short-term survival among cirrhotics. Hepatology. 1987 Jul-Aug;7(4):660-4. doi: 10.1002/hep.1840070408. |
| Background | Jahren Kristoffersen N, Nortveldt F & Skaug EA. Grundläggande omvårdnad del 1. Stockholm: Liber AB, 2005. |
| 22139897 | Background | Jones JC, Coombes JS, Macdonald GA. Exercise capacity and muscle strength in patients with cirrhosis. Liver Transpl. 2012 Feb;18(2):146-51. doi: 10.1002/lt.22472. |
| 16925617 | Background | Jorgensen R. A phenomenological study of fatigue in patients with primary biliary cirrhosis. J Adv Nurs. 2006 Sep;55(6):689-97. doi: 10.1111/j.1365-2648.2006.03958.x. |
| 18922174 | Background | Kalaitzakis E, Josefsson A, Bjornsson E. Type and etiology of liver cirrhosis are not related to the presence of hepatic encephalopathy or health-related quality of life: a cross-sectional study. BMC Gastroenterol. 2008 Oct 15;8:46. doi: 10.1186/1471-230X-8-46. |
| 11172350 | Background | Kamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172. |
| Background | Kirkevold M. Omvårdnadsteorier; Analys och utvärdering (2nd Ed). Lund: Studentlitteratur, 2000. |
| 22369440 | Background | Koay K, Schofield P, Jefford M. Importance of health literacy in oncology. Asia Pac J Clin Oncol. 2012 Mar;8(1):14-23. doi: 10.1111/j.1743-7563.2012.01522.x. |
| 21459951 | Background | Kroese ME, Severens JL, Schulpen GJ, Bessems MC, Nijhuis FJ, Landewe RB. Specialized rheumatology nurse substitutes for rheumatologists in the diagnostic process of fibromyalgia: a cost-consequence analysis and a randomized controlled trial. J Rheumatol. 2011 Jul;38(7):1413-22. doi: 10.3899/jrheum.100753. Epub 2011 Apr 1. |
| Background | Larsson, B, Larsson G, Larsson M & Starrin B. KUPP-boken: Vägledning till frågeformuläret KUPP, Kvalitet ur patientperspektiv. Stockholm: Grafiska Gruppen, 2001. |
| 9801632 | Background | Larsson G, Larsson BW, Munck IM. Refinement of the questionnaire 'quality of care from the patient's perspective' using structural equation modelling. Scand J Caring Sci. 1998;12(2):111-8. |
| 22228880 | Background | Maldonado-Garza HJ, Vazquez-Elizondo G, Gaytan-Torres JO, Flores-Rendon AR, Cardenas-Sandoval MG, Bosques-Padilla FJ. Prevalence of minimal hepatic encephalopathy in cirrhotic patients. Ann Hepatol. 2011 Jun;10 Suppl 2:S40-4. |
| 23296469 | Background | Nardelli S, Pentassuglio I, Pasquale C, Ridola L, Moscucci F, Merli M, Mina C, Marianetti M, Fratino M, Izzo C, Merkel C, Riggio O. Depression, anxiety and alexithymia symptoms are major determinants of health related quality of life (HRQoL) in cirrhotic patients. Metab Brain Dis. 2013 Jun;28(2):239-43. doi: 10.1007/s11011-012-9364-0. Epub 2013 Jan 8. |
| 1408330 | Background | Pasqualetti P, Di Lauro G, Festuccia V, Giandomenico G, Casale R. Prognostic value of Pugh's modification of Child-Turcotte classification in patients with cirrhosis of the liver. Panminerva Med. 1992 Apr-Jun;34(2):65-8. |
| Background | Prytz H & Ståhl P. Levercirros och dess kliniska manifestationer. I R Hultcrantz, A Bergquist, S Lindgren, M Simrén, P Stål & OB Suhr (Eds.). Gastroenterologi och hepatologi. Stockholm: Liber. (1st ed, pp. 451-475), 2011. |
| 4541913 | Background | Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973 Aug;60(8):646-9. doi: 10.1002/bjs.1800600817. No abstract available. |
| 19795023 | Background | Riley TR, Taheri M, Schreibman IR. Does weight history affect fibrosis in the setting of chronic liver disease? J Gastrointestin Liver Dis. 2009 Sep;18(3):299-302. |
| 21884449 | Background | Schadewaldt V, Schultz T. Nurse-led clinics as an effective service for cardiac patients: results from a systematic review. Int J Evid Based Healthc. 2011 Sep;9(3):199-214. doi: 10.1111/j.1744-1609.2011.00217.x. |
| 22652784 | Background | Shen C, Zhao CY, Zhang R, Qiao L. Obesity-related hepatocellular carcinoma: roles of risk factors altered in obesity. Front Biosci (Landmark Ed). 2012 Jun 1;17(6):2356-70. doi: 10.2741/4057. |
| 21951242 | Background | Sheridan SL, Halpern DJ, Viera AJ, Berkman ND, Donahue KE, Crotty K. Interventions for individuals with low health literacy: a systematic review. J Health Commun. 2011;16 Suppl 3:30-54. doi: 10.1080/10810730.2011.604391. |
| 18562991 | Background | Shutt JD, Robathan J, Vyas SK. Impact of a clinical nurse specialist on the treatment of chronic hepatitis C. Br J Nurs. 2008 May 8-21;17(9):572-5. doi: 10.12968/bjon.2008.17.9.29242. |
| 23459041 | Background | Volk ML, Fisher N, Fontana RJ. Patient knowledge about disease self-management in cirrhosis. Am J Gastroenterol. 2013 Mar;108(3):302-5. doi: 10.1038/ajg.2012.214. |
| 15763233 | Background | Wakim-Fleming J, Mullen KD. Long-term management of alcoholic liver disease. Clin Liver Dis. 2005 Feb;9(1):135-49. doi: 10.1016/j.cld.2004.10.001. |
| 8560308 | Background | The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization. Soc Sci Med. 1995 Nov;41(10):1403-9. doi: 10.1016/0277-9536(95)00112-k. |
| 12512033 | Background | Wiesner R, Edwards E, Freeman R, Harper A, Kim R, Kamath P, Kremers W, Lake J, Howard T, Merion RM, Wolfe RA, Krom R; United Network for Organ Sharing Liver Disease Severity Score Committee. Model for end-stage liver disease (MELD) and allocation of donor livers. Gastroenterology. 2003 Jan;124(1):91-6. doi: 10.1053/gast.2003.50016. |
| 16338915 | Background | Weiss BD, Mays MZ, Martz W, Castro KM, DeWalt DA, Pignone MP, Mockbee J, Hale FA. Quick assessment of literacy in primary care: the newest vital sign. Ann Fam Med. 2005 Nov-Dec;3(6):514-22. doi: 10.1370/afm.405. |
| 11434627 | Background | Weissenborn K, Ennen JC, Schomerus H, Ruckert N, Hecker H. Neuropsychological characterization of hepatic encephalopathy. J Hepatol. 2001 May;34(5):768-73. doi: 10.1016/s0168-8278(01)00026-5. No abstract available. |
| 23375997 | Background | Wigg AJ, McCormick R, Wundke R, Woodman RJ. Efficacy of a chronic disease management model for patients with chronic liver failure. Clin Gastroenterol Hepatol. 2013 Jul;11(7):850-8.e1-4. doi: 10.1016/j.cgh.2013.01.014. Epub 2013 Jan 29. |
| 8248668 | Background | Wilde B, Starrin B, Larsson G, Larsson M. Quality of care from a patient perspective--a grounded theory study. Scand J Caring Sci. 1993;7(2):113-20. doi: 10.1111/j.1471-6712.1993.tb00180.x. |
| 12201896 | Background | Wilde Larsson B, Larsson G. Development of a short form of the Quality from the Patient's Perspective (QPP) questionnaire. J Clin Nurs. 2002 Sep;11(5):681-7. doi: 10.1046/j.1365-2702.2002.00640.x. |
| 39890127 | Derived | Hjorth M, Sjoberg D, Svanberg A, Lo Martire R, Kaminsky E, Rorsman F. Health-related quality of life in patients with liver cirrhosis following adjunctive nurse-based care versus standard medical care: a pragmatic, multicentre, randomised controlled study. BMJ Open Gastroenterol. 2025 Jan 31;12(1):e001694. doi: 10.1136/bmjgast-2024-001694. |
| 38637755 | Derived | Hjorth M, Svanberg A, LoMartire R, Kaminsky E, Rorsman F. Patient perceived quality of cirrhosis care- adjunctive nurse-based care versus standard medical care: a pragmatic multicentre randomised controlled study. BMC Nurs. 2024 Apr 19;23(1):251. doi: 10.1186/s12912-024-01934-9. |
| 30337316 | Derived | Hjorth M, Sjoberg D, Svanberg A, Kaminsky E, Langenskiold S, Rorsman F. Nurse-led clinic for patients with liver cirrhosis-effects on health-related quality of life: study protocol of a pragmatic multicentre randomised controlled trial. BMJ Open. 2018 Oct 17;8(10):e023064. doi: 10.1136/bmjopen-2018-023064. |
| Swedish Code of Statutes 1982:763. Swedish health care act. Retrieved from the Swedish parliament | View source |
| Swedish Code of Statutes 1998:204. Swedish Personal Data Act. Retrieved from the Swedish parliament | View source |
| Jan 28, 2026 |
| Apr 17, 2026 | May 8, 2026 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008919 |
| Investigative Techniques |
| D015984 | Causality |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |