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NCT Number: NCT02957253

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology department, Falun, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risk factors

Other

monitoring risk factors due to deterioration of the liver disease

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Child-Pugh scale

    Time frame: At baseline after 12 and 24 months

    Liver cirrhosis specific calculator to measure long time survival

  3. Presence of Hepatic encephalopathy

    Time frame: At baseline after 12 and 24 months

    Paper and pencil test the psychometric hepatic encephalopathy score (PHES)

  4. 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)

  5. 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

  6. 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.

  7. 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)

  8. Health care consumption

    Time frame: through study completion, 24 months

    Medical Review of inpatient and outpatient care

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2016
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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