ClinicalTrials.gg
Enrolling by invitationNCT07273331Updated Dec 9, 2025

Nursing Needs of Patients With Cirrhosis

An observational study in Cirrhoses, Liver, sponsored by Landspitali University Hospital. Enrolling by invitation at 2 sites in Iceland. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Landspitali University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
150
Sex
All
01

Study summary

The primary objective of this study is to examine the quality of life, disease-related knowledge, and perceived nursing needs of adult patients diagnosed with liver cirrhosis who attend the outpatient clinic at Landspítali University Hospital. The study aims to generate clinically relevant insights that may inform improvements in nursing care and patient support. The research questions are: 1. what is the quality of life of patients with cirrhosis. 2. How do patients with cirrhosis describe their knowledge about the disease; and 3. How do patients with cirrhosis describe their nursing needs. Three questionnaires will be given to the patients. To assess quality of life Chronic Liver Disease Questionnaire (CLDQ) will be used. To validate knowledge and nursing needs two questionnaires will be used. The disease severity will be evaluated through clinical indicators such as MELD and Child-Pugh scores. In addition, the study will analyze demographic variables, including age, gender, education level, and employment status, to identify potential associations with quality of life, disease burden, and perceived care needs. By integrating clinical data, patient-reported outcomes, and sociodemographic factors, the study aims to support the development of evidence-based, individualized nursing strategies that enhance symptom management, reduce hospital admissions, and improve overall well-being for individuals living with liver cirrhosis in Iceland. The study has scientific value at national and international level, as it is based on a recognized measurement tool (CLDQ) and is in line with international emphasis on individualized treatment and early intervention in liver diseases. The results will provide deeper understanding of the quality of life and nursing needs of individuals with cirrhosis and support the development of targeted nursing services. The study can also shed light on the relationship between demographic factors and disease severity with service needs, as well as support policy development, education and improvements in the care of patients with chronic liver diseases. This study will have practical benefits for both patients and the Icelandic healthcare system. By identifying the specific nursing needs of individuals with cirrhosis, the study will support the development of targeted, individualized care plans that address symptom burden, disease progression, and psychosocial challenges. Improved nursing services, such as nutritional counseling, symptom management, and education about self-care of the disease, can improve patients' quality of life and promote greater independence.

Read the detailed description

Cirrhosis is the end-stage of various liver diseases and has become increasingly prevalent in Europe due to rising obesity, excessive alcohol consumption, and undiagnosed liver diseases among marginalized groups, including immigrants (Karlsen et al., 2022). The EASL-Lancet Liver Commission report emphasizes that liver diseases are not only a medical issue but also a social and public health concern, reflecting and exacerbating inequalities in European healthcare systems (Karlsen et al., 2022). The report highlights that liver diseases are the second most common cause of working years lost in Europe, second only to ischemic heart disease, and that most deaths from liver diseases occur in working-age individuals. Despite many liver diseases being both preventable and treatable, diagnosis is often delayed, and treatment is provided at later stages, reducing quality of life and increasing healthcare costs. The EASL-Lancet report calls for a radical shift in the approach to liver health, emphasizing early diagnosis, prevention, and personalized care. Special emphasis is placed on the importance of nurses and other healthcare professionals in multidisciplinary teamwork, where nurses play a key role in education, support, and coordination of care. A nationwide population-based prospective study of cirrhosis in Iceland further supports these findings, revealing that the incidence of cirrhosis in Iceland has increased considerably during the last 4 decades and is currently comparable to other Western countries (Olafsson et al., 2021). Alcohol is still the leading cause, followed by metabolic-dysfunction associated steatotic liver disease (MASLD) and these two condition represent approximately two thirds of all etiologies in Iceland (Haraldsson et al. 2024). These studies underscores the need for effective management strategies and the critical role of healthcare professionals in improving patient outcomes. These insights particularly underscore the importance of developing nursing models in outpatient clinics that address the needs of patients with cirrhosis, focusing on quality of life, early intervention, and continuity of care. Many patients struggle with symptoms that disrupt daily activities and reduce independence, while uncertainty about disease progression adds to anxiety and feelings of vulnerability (Hansen et al., 2021). Nursing interventions have been shown to make a meaningful difference in the lives of patients with cirrhosis. Structured programs that focus on symptom monitoring, individualized education, and psychosocial support have improved patients´ experience of care and fostered a sense of empowerment (Hjorth et al., 2023). Nurse-led services are associated with fewer hospital readmissions and better long-term outcomes, as nurses are often able to detect subtle changes in patients´ conditions and intervene early to prevent complications (Kalo et al., 2023; Hjorth et al., 2025). In addition to clinical care, nurses provide vital emotional support, education, and advocacy, all of which are essential for maintaining an enhanced QoL.

The research plan, The study's design is cross-sectional in design and aims to recruit approximately 100-150 adult participants over a period of 10 months. Inclusion criteria are that participants must be 18 years of age or older with a confirmed diagnosis of cirrhosis, fluent in Icelandic or English. Exclusion criteria are severe cognitive impairment and serious or acute illness to ensure the reliability of self-reported data. Upon enrollment, participants will undergo a structured background interview to collect demographic data (age, gender, education level, employment status), disease perception, and symptom burden. This study utilizes three structured questionnaires to assess patient-reported outcomes related to quality of life, disease knowledge, and perceived nursing needs. The primary instrument is the Chronic Liver Disease Questionnaire (CLDQ), a validated tool specifically designed to evaluate quality of life in individuals with chronic liver conditions. The CLDQ covers six key domains: fatigue, emotional function, daily activity, abdominal symptoms, systemic symptoms, and worry related to illness. Each domain is assessed through multiple items that reflect the patient's experience over recent weeks. The questionnaire has demonstrated strong psychometric properties, including high internal consistency (Cronbach's alpha > 0.80), and has been approved for use in both Icelandic and English by the original author and publisher. In addition to the CLDQ, two custom-designed questionnaires were developed to address gaps in existing tools and to reflect the specific needs of patients with cirrhosis in the Icelandic healthcare context. The first, titled "Nursing Needs of Individuals with Liver Cirrhosis," consists of eleven statements addressing various aspects of nursing care and support. Participants indicate their level of agreement with each statement, which covers topics such as dietary guidance, symptom management, medication adherence, monitoring of weight and fluid retention, sleep and physical activity advice, emotional and social support, and access to nursing consultation. This instrument provides insight into patients' expectations and perceived gaps in outpatient nursing services. The second custom tool, "Knowledge of Liver Cirrhosis," is designed to assess patients' understanding of their condition. It includes eleven statements related to the causes, symptoms, diagnosis, treatment, and complications of cirrhosis, as well as the role of the liver in overall health. For each item, participants indicate whether the statement is true, false, or if they are unsure. Responses are scored to reflect the level of knowledge: no knowledge (0 points), low (1-3), moderate (4-6), good (7-9), and very good (10-11). This questionnaire aims to identify educational needs and inform targeted patient education strategies.

Clinical data, including diagnosis, complications, treatment history, and laboratory results, will be extracted from electronic health records. Participants will provide a blood sample during their outpatient visit. The sample will be used to assess liver function (ALP, ASAT, ALAT, GGT, bilirubin, albumin, INR), renal function (creatinine, sodium, potassium), hematological parameters (hemoglobin, white blood cells, platelets), iron status (iron, transferrin saturation), vitamin D levels, and B-Peth (phosphatidylethanol) as a biomarker of recent alcohol consumption. These results will be used to calculate MELD and Child-Pugh scores and to contextualize patient-reported outcomes. Blood sampling will be performed by trained clinical staff in accordance with standard hospital procedures. Data collection takes place during a planned outpatient visit. It begins with an interview according to an interview framework and an assessment of hepatic encephalopathy using animal testing. Disease severity will be calculated using MELD and Child-Pugh scores, based on both interview data and laboratory findings. Work and timeline: The study will start in November 2025 and end will be conducted for 20 months. Workpackage 1: Data collection will be done at Internal disease outpatient department in Landspitali where patients will come to participate from November 2025 - August 2026. Workpackage 2: will be analysis of data done with assistance from statistician from April 2026 to December 2026. Workpackage 3: July 2026 to June 2027 will be writing the final thesis done by master student. Workpackage 4: June 2027 to October 2027, writing manuscript for publication. The study has scientific value at the national and international level, as it is based on a recognized measurement tool (CLDQ) and is in line with international priorities for individualized treatment and early intervention in liver diseases. The results provide a deeper understanding of the quality of life and nursing needs of individuals with cirrhosis and support the development of targeted nursing services. The study will shed light on the relationship between demographic factors and disease severity with service needs, as well as support policy development, education and improvements in the care of patients with chronic liver diseases.

Management and co-operation This research is a collaboration between Landpitali University Hospital and University of Iceland, Faculty of Nursing and Midwifery and Faculty of Medicine. The study is managed by Dr. Þórunn Scheving Elíasdóttir, Associate Professor and Academic Chair of Anesthesia- and Perioperative Nursing at the University of Iceland, Faculty of Nursing and Midwifery.

Data management and publication of results in open access The results of the study will be used to support the development of outpatient nursing services for individuals with cirrhosis and to promote more targeted and individualized treatment. They will be published in a master's thesis at the University of Iceland and the aim is to publish them in both Icelandic and international open-access peer-reviewed journals in the field of nursing and health sciences. The results will also be presented at conferences related to health science research, both domestically and internationally, where the emphasis will be on communicating knowledge to professionals and supporting the clinical development of services for this patient group. The results will be published regardless of the outcome, in accordance with the ethics committee's rules of conduct.

02

Conditions studied

  • Cirrhoses, Liver

Keywords

  • cross-sectional study,
  • nursing
03

In context

Lead sponsor

Landspitali University Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cirrhosis in outpatient clinic at Landspitali

Eligibility criteria

Inclusion Criteria:

  • Participants eligible for enrolment must meet the following criteria:

    • Be 18 years of age or older
    • Have a confirmed diagnosis of liver cirrhosis
    • Be fluent in Icelandic or English, to ensure participants can comprehend study materials and provide .

These criteria are designed to ensure that participants can meaningfully engage with the study procedures and provide reliable patient-reported data.

Exclusion Criteria:Participants will be excluded from the study if they meet any of the following conditions:

  • Exhibit severe cognitive impairment that may interfere with informed consent or the completion of questionnaires
  • Are experiencing acute or severe illness at the time of recruitment, such as recent hospitalization due to hepatic encephalopathy or bleeding from esophageal varices These exclusion criteria are intended to protect vulnerable individuals and maintain the integrity of the data collected.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • patients with cirrhosis

    patients with cirrhosis in outpatient clinic

    Other: blood sample · Diagnostic Test: blood samples for analysis of cirrhosis

Interventions

  • Otherblood sample

    measurement of blood status related to cirrhosis

    Also known as: interview

  • Diagnostic testblood samples for analysis of cirrhosis

    interviews and blood sample taken

06

What researchers measure

Primary outcomes

  1. Chronic Liver Disease Questionnaire score

    score will be collected

    Time frame: November 2025 to End of August 2026

07

Study locations

2 sites
  • Eirberg Eiríksgata 34
    Reykjavik, 105, Iceland
  • Faculty of Nursing and Midwifery
    Reykjavik, 105, Iceland
08

References and documents

Individual participant data

Plan to share: No — Will not be shared outside the researchers group in the study

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for Sep 2026, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2025
First posted
Dec 9, 2025
StartActual
Nov 17, 2025
Primary completionEst.
Sep 1, 2026
CompletionEst.
Dec 31, 2028
Last update
Dec 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07273331
Lead sponsor
Landspitali University Hospital
Collaborators
University of Iceland
Responsible party
Thora Jenny Gunnarsdottir (Professor, University of Iceland) — Principal investigator
First posted
Dec 9, 2025
Start date
Nov 17, 2025
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Dec 9, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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