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

NCT02957253 | Completed

• 1 other identifier: 2016/146
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 6

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.

Conditions

Liver Cirrhosis

Keywords

Quality of care; Health related quality of life; Nurse-led clinic; Health economics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical examination of presence of ascites

  At baseline after 12 and 24 months

• Child-Pugh scale

  At baseline after 12 and 24 months

• Presence of Hepatic encephalopathy

  At baseline after 12 and 24 months

• Health literacy

  At baseline after 12 and 24 months

• Model of end stage liver disease (MELD-score)

  At baseline after 12 and 24 months

Study Arms (4)

Intervention (CI)

EXPERIMENTAL

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

Other: risk factors; Other: lifestyle; Other: Nurse-led clinic

Control (CC)

NO INTERVENTION

Compensated Control (CC)

Intervention (DI)

EXPERIMENTAL

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

Control (DC)

NO INTERVENTION

Decompensated Control (DC)

Interventions

risk factors OTHER

monitoring risk factors due to deterioration of the liver disease

Intervention (CI); Intervention (DI)

self-care OTHER

information and motivation to adherence to self-care instructions and medical treatment

Intervention (DI)

nutrition OTHER

nutritional assessment and activities to prevent malnutrition

Intervention (DI)

lifestyle OTHER

motivation of lifestyle changes essential for disease progress and

Intervention (CI); Intervention (DI)

psychosocial needs OTHER

psychosocial care.

Intervention (DI)

Nurse-led clinic OTHER

compensated disease once yearly, decompensated disease twice a month to every third month

Intervention (CI); Intervention (DI)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Fundation of Ester Åsberg-Lindbergs memories, Falun; Sweden: collaborator
• Center for Clinical Research Dalarna, Sweden: collaborator

Study Sites (6)

Gastroenterology department

Falun, 791 82, Sweden

Location

Gastroenterology outpatientclinic, Sahlgrenska hospital

Gothenburg, 41345, Sweden

Location

Gastroenterology outpatient department, Skane Universityhospital

Malmo, 20502, Sweden

Location

Gastroenterology department, Örebro Universityhospital

Örebro, 701 85, Sweden

Location

Gastroenterology department, Danderyd hospital

Stockholm, 182 88, Sweden

Location

Gastroenterology department, Uppsala academical hospital

Uppsala, 751 85, Sweden

Location

Related Publications (46)

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Related 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

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Risk Factors; Self Care; Nutritional Status; Practice Patterns, Nurses'

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Lars Rönnblom, Professor

  Dept of Medical Sciencies, Uppsala University, Uppsala, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: November 7, 2016
• Study Start: November 17, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)