NCT07273331

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Nov 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Nov 2025Dec 2028

Study Start

First participant enrolled

November 17, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 9, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

November 26, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

cross-sectional study,nursing

Outcome Measures

Primary Outcomes (1)

  • Chronic Liver Disease Questionnaire score

    score will be collected

    November 2025 to End of August 2026

Study Arms (1)

patients with cirrhosis

patients with cirrhosis in outpatient clinic

Other: blood sampleDiagnostic Test: blood samples for analysis of cirrhosis

Interventions

measurement of blood status related to cirrhosis

Also known as: interview
patients with cirrhosis

interviews and blood sample taken

patients with cirrhosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cirrhosis in outpatient clinic at Landspitali

You may qualify if:

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

You may not qualify if:

  • Exhibit severe cognitive impairment that may interfere with informed consent or the completion of questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eirberg Eiríksgata 34

Reykjavik, 105, Iceland

Location

Faculty of Nursing and Midwifery

Reykjavik, 105, Iceland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

hemoglobin, platelets, white blood cell, ALP, AST, ALT, GGT, Bilirubin, Creatinine, Albumin, INR, Sodium, potassium, iron, iron binding capacity, ferritin, vitamin D, B-peth

MeSH Terms

Interventions

Blood Specimen CollectionInterviews as Topic

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 9, 2025

Study Start

November 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

December 9, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Will not be shared outside the researchers group in the study

Locations