Effects on Liver Cirrhotic Patient's Health Related Quality of Life by a Nurse-led Clinic: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 6
- 主要终点
- Changes in Health related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention (CI)
Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.
干预措施: risk factors (Other)
Intervention (CI)
Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.
干预措施: lifestyle (Other)
Intervention (CI)
Compensated intervention (CI). Nurse-led clinic one time per year. Focus on Life style and risk factors.
干预措施: Nurse-led clinic (Other)
Control (CC)
Compensated Control (CC)
Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
干预措施: risk factors (Other)
Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
干预措施: self-care (Other)
Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
干预措施: nutrition (Other)
Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
干预措施: lifestyle (Other)
Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
干预措施: psychosocial needs (Other)
Intervention (DI)
Decompensated intervention (DI). Nurse-led clinic two times every month to every third month. Focus on Lifestyle, risk factors, nutrition, selfcare and psychosocial needs
干预措施: Nurse-led clinic (Other)
Control (DC)
Decompensated Control (DC)
结局指标
主要结局
Changes in Health related quality of life
时间窗: At baseline after 12 and 24 months
Patient survey using the instrument from Research and development, RAND 36-item heath survey
次要结局
- Presence of Hepatic encephalopathy(At baseline after 12 and 24 months)
- Health literacy(At baseline after 12 and 24 months)
- Health care consumption(through study completion, 24 months)
- Clinical examination of presence of ascites(At baseline after 12 and 24 months)
- Child-Pugh scale(At baseline after 12 and 24 months)
- Model of end stage liver disease (MELD-score)(At baseline after 12 and 24 months)
- Risk assessment of malnutrition using the instrument the Royal free hospital - nutritional prioritizing tool(At baseline after 12 and 24 months)
- Changes in patients experienced Quality of care(At baseline after 12 and 24 months)
研究者
Maria Hjorth
Principal investigator
Uppsala University