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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957253
• Other study ID #: 2016/146
• Status: Completed
• Phase: N/A
• Start date: November 17, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Other:
• risk factors
monitoring risk factors due to deterioration of the liver disease
• self-care
information and motivation to adherence to self-care instructions and medical treatment
• nutrition
nutritional assessment and activities to prevent malnutrition
• lifestyle
motivation of lifestyle changes essential for disease progress and
• psychosocial needs
psychosocial care.
• Nurse-led clinic
compensated disease once yearly, decompensated disease twice a month to every third month

Locations

Country	Name	City	State
Sweden	Gastroenterology department	Falun
Sweden	Gastroenterology outpatientclinic, Sahlgrenska hospital	Gothenburg
Sweden	Gastroenterology outpatient department, Skane Universityhospital	Malmo
Sweden	Gastroenterology department, Örebro Universityhospital	Örebro
Sweden	Gastroenterology department, Danderyd hospital	Stockholm
Sweden	Gastroenterology department, Uppsala academical hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Center for Clinical Research Dalarna, Sweden, Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (43)

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Health related quality of life	Patient survey using the instrument from Research and development, RAND 36-item heath survey	At baseline after 12 and 24 months
Secondary	Clinical examination of presence of ascites	Severity of ascites is grouped as none, mild or severe	At baseline after 12 and 24 months
Secondary	Child-Pugh scale	Liver cirrhosis specific calculator to measure long time survival	At baseline after 12 and 24 months
Secondary	Presence of Hepatic encephalopathy	Paper and pencil test the psychometric hepatic encephalopathy score (PHES)	At baseline after 12 and 24 months
Secondary	Health literacy	Standardized interview of a table of contents using the instrument The newest vital sign (NVS)	At baseline after 12 and 24 months
Secondary	Model of end stage liver disease (MELD-score)	A liver cirrhosis specific calculator to assess short time survival rate	At baseline after 12 and 24 months
Secondary	Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool	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
Secondary	Changes in patients experienced Quality of care	Patient survey using the instrument Quality of care from the the patient's perspective (QPP)	At baseline after 12 and 24 months
Secondary	Health care consumption	Medical Review of inpatient and outpatient care	through study completion, 24 months

External Links

•   Practice Guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. (2014). Hepatic encephalopathy in chronic liver disease.
•   Swedish Code of Statutes 1982:763. Swedish health care act. Retrieved from the Swedish parliament
•   Swedish Code of Statutes 1998:204. Swedish Personal Data Act. Retrieved from the Swedish parliament