Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic

March 27, 2023 updated by: Maria Hjorth, Uppsala University

Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Falun, Sweden, 791 82
        • Gastroenterology department
      • Gothenburg, Sweden, 41345
        • Gastroenterology outpatientclinic, Sahlgrenska hospital
      • Malmo, Sweden, 20502
        • Gastroenterology outpatient department, Skane Universityhospital
      • Stockholm, Sweden, 182 88
        • Gastroenterology department, Danderyd hospital
      • Uppsala, Sweden, 751 85
        • Gastroenterology department, Uppsala academical hospital
      • Örebro, Sweden, 701 85
        • Gastroenterology department, Örebro Universityhospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • within the last 24 months diagnosed liver cirrhosis based on clinical investigation, laboratory findings, histology, magnetic resonance imaging, computer tomography, ultrasound or elastography
  • followed at one of the six Gastroenterology departments

Exclusion Criteria:

  • Insufficient knowledge of the Swedish language
  • Persistent hepatic ecephalopathy grades 2-4
  • Comorbidity: Chronic obstructive pulmonary disease grade 3-4, Coronary heart disease New York Heart Association Functional Classification class 3-4, Dementia, Actual advanced cancer, Stroke with sequelae, Severe psychiatric disease, Renal failure requiring dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (CI)
Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.
Other: risk factors
monitoring risk factors due to deterioration of the liver disease
Other: lifestyle
motivation of lifestyle changes essential for disease progress and
Other: Nurse-led clinic
compensated disease once yearly, decompensated disease twice a month to every third month
No Intervention: Control (CC)
Compensated Control (CC)
Experimental: Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
Other: risk factors
monitoring risk factors due to deterioration of the liver disease
Other: lifestyle
motivation of lifestyle changes essential for disease progress and
Other: Nurse-led clinic
compensated disease once yearly, decompensated disease twice a month to every third month
Other: self-care
information and motivation to adherence to self-care instructions and medical treatment
Other: nutrition
nutritional assessment and activities to prevent malnutrition
Other: psychosocial needs
psychosocial care.
No Intervention: Control (DC)
Decompensated Control (DC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Health related quality of life
Time Frame: At baseline after 12 and 24 months
Patient survey using the instrument from Research and development, RAND 36-item heath survey
At baseline after 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical examination of presence of ascites
Time Frame: At baseline after 12 and 24 months
Severity of ascites is grouped as none, mild or severe
At baseline after 12 and 24 months
Child-Pugh scale
Time Frame: At baseline after 12 and 24 months
Liver cirrhosis specific calculator to measure long time survival
At baseline after 12 and 24 months
Presence of Hepatic encephalopathy
Time Frame: At baseline after 12 and 24 months
Paper and pencil test the psychometric hepatic encephalopathy score (PHES)
At baseline after 12 and 24 months
Health literacy
Time Frame: At baseline after 12 and 24 months
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)
Time Frame: At baseline after 12 and 24 months
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
Time Frame: At baseline after 12 and 24 months
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
Health care consumption
Time Frame: through study completion, 24 months
Medical Review of inpatient and outpatient care
through study completion, 24 months
Changes in patients experienced Quality of care
Time Frame: At baseline after 12 and 24 months
Patient survey using the instrument Quality of care from the the patient's perspective (QPP)
At baseline after 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Center for Clinical Research Dalarna, Sweden
Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2016

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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