Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic
- Conditions
- Liver Cirrhosis
- Interventions
- Other: risk factorsOther: lifestyleOther: self-careOther: Nurse-led clinicOther: nutritionOther: psychosocial needs
- Registration Number
- NCT02957253
- Lead Sponsor
- Uppsala University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention (DI) risk factors Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs Intervention (DI) psychosocial needs Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs Intervention (CI) lifestyle Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors. Intervention (CI) Nurse-led clinic Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors. Intervention (DI) lifestyle Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs Intervention (DI) Nurse-led clinic Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs Intervention (CI) risk factors Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors. Intervention (DI) nutrition Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs Intervention (DI) self-care Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
- Primary Outcome Measures
Name Time Method Changes in Health related quality of life At baseline after 12 and 24 months Patient survey using the instrument from Research and development, RAND 36-item heath survey
- Secondary Outcome Measures
Name Time Method Health care consumption through study completion, 24 months Medical Review of inpatient and outpatient care
Clinical examination of presence of ascites At baseline after 12 and 24 months Severity of ascites is grouped as none, mild or severe
Child-Pugh scale At baseline after 12 and 24 months Liver cirrhosis specific calculator to measure long time survival
Presence of Hepatic encephalopathy At baseline after 12 and 24 months Paper and pencil test the psychometric hepatic encephalopathy score (PHES)
Health literacy At baseline after 12 and 24 months Standardized interview of a table of contents using the instrument The newest vital sign (NVS)
Model of end stage liver disease (MELD-score) At baseline after 12 and 24 months A liver cirrhosis specific calculator to assess short time survival rate
Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool 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.
Changes in patients experienced Quality of care At baseline after 12 and 24 months Patient survey using the instrument Quality of care from the the patient's perspective (QPP)
Trial Locations
- Locations (6)
Gastroenterology department
🇸🇪Falun, Sweden
Gastroenterology outpatientclinic, Sahlgrenska hospital
🇸🇪Gothenburg, Sweden
Gastroenterology department, Danderyd hospital
🇸🇪Stockholm, Sweden
Gastroenterology outpatient department, Skane Universityhospital
🇸🇪Malmo, Sweden
Gastroenterology department, Uppsala academical hospital
🇸🇪Uppsala, Sweden
Gastroenterology department, Örebro Universityhospital
🇸🇪Örebro, Sweden