Clinical trial NCT02957253: Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic
Official title: Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Quality of care
Health related quality of life
Nurse-led clinic
Health economics
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden
name: Center for Clinical Research Dalarna, Sweden
First posted: 2016-11-06
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Health related quality of life
timeFrame: At baseline after 12 and 24 months
Secondary outcomes:
measure: Clinical examination of presence of ascites
timeFrame: At baseline after 12 and 24 months
measure: Child-Pugh scale
timeFrame: At baseline after 12 and 24 months
measure: Presence of Hepatic encephalopathy
timeFrame: At baseline after 12 and 24 months
measure: Health literacy
timeFrame: At baseline after 12 and 24 months
measure: Model of end stage liver disease (MELD-score)
timeFrame: At baseline after 12 and 24 months
measure: Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool
timeFrame: At baseline after 12 and 24 months
measure: Changes in patients experienced Quality of care
timeFrame: At baseline after 12 and 24 months
measure: Health care consumption
timeFrame: through study completion, 24 months
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Gastroenterology department
city: Gothenburg
country: Sweden
facility: Gastroenterology outpatientclinic, Sahlgrenska hospital
city: Malmo
country: Sweden
facility: Gastroenterology outpatient department, Skane Universityhospital
city: Stockholm
country: Sweden
facility: Gastroenterology department, Danderyd hospital
city: Uppsala
country: Sweden
facility: Gastroenterology department, Uppsala academical hospital
city: Örebro
country: Sweden
facility: Gastroenterology department, Örebro Universityhospital
Study officials:
affiliation: Dept of Medical Sciencies, Uppsala University, Uppsala, Sweden
name: Lars Rönnblom, Professor
role: STUDY_CHAIR
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