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

Uppsala University

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Other: nutrition; Other: lifestyle; Other: risk factors; Other: self-care; Other: psychosocial needs; Other: Nurse-led clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT02957253

2016/146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 4 patient groups

Intervention (CI)

Experimental group

Description:

Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.

Treatment:

Other: lifestyle

Other: risk factors

Other: Nurse-led clinic

Control (CC)

No Intervention group

Description:

Compensated Control (CC)

Intervention (DI)

Experimental group

Description:

Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs

Treatment:

Other: lifestyle

Other: nutrition

Other: risk factors

Other: Nurse-led clinic

Other: self-care

Other: psychosocial needs

Control (DC)

No Intervention group

Description:

Decompensated Control (DC)