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临床试验/NCT04158986
NCT04158986已完成不适用

Post-discharge Nurse-driven Intervention Program for Patients With Decompensated Liver Cirrhosis

Copenhagen University Hospital, Hvidovre2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
2
主要终点
Time from discharge to first readmission.

研究概览

简要总结

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.

详细描述

Since 1970 the mortality from cirrhosis has increased with 26.7 %, with a 50% mortality rate within 2 years of diagnosis. Grave complications result in functional impairment and reduced quality of life. 20-37 % of patients with liver cirrhosis are readmitted less than 30 days after a hospitalization for decompensation. These patients have a higher 90-day mortality rate than those who avoid readmission. Re-admissions have great personal-, societal- and economic consequences.

In a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis, compared with standard follow-up will be investigated.

The intervention, based on concepts from Family Nursing, will comprise three home-visits within eight weeks after discharge including therapeutic conversations focusing on strengthening participants' family relationships and social networks, disease education and help to initiate contact to municipal offers. After 12 weeks the participants will be followed-up by telephone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Allocation is blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with liver cirrhosis and one or more complications hereto during admission to the Gastro Unit, AHH. Complications include, but are not limited to: hepatic encephalopathy, infection, ascites, edema, kidney failure, upper or lower GI bleeding.
  • Patients must read and understand Danish.
  • Adults >18 years.

排除标准

  • When the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.
  • Patients with comorbidity as the primary diagnosis and where an independent rehabilitation or post-discharge program is offered, for example hip fracture, chronic obstructive pulmonary disease etc.
  • Patients diagnosed with an active and invasive malignant disease.
  • Residency outside the catchment area of Amager Hvidovre Hospital.

结局指标

主要结局

Time from discharge to first readmission.

时间窗: Time from discharge to first readmission during all readmissions due to liver cirrhosis in the 6 month trial time.

Time from discharge to first readmission.

Duration of readmissions

时间窗: Duration of readmissions due to liver cirrhosis in the 6 month trial time.

Duration of readmissions due to liver cirrhosis

Number of readmissions

时间窗: Number of readmissions within 2 years.

Number of readmissions within 2 years

次要结局

  • Self-perceived health before and after intervention(The change in self-perceived health before and after intervention (6 months trial time).)
  • Functional disability in work-, social-, and family life before and after intervention(The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time))
  • Health related quality of life before and after intervention(The change in health related quality of life before and after intervention (6 months trial time).)
  • Mortality(The mortality rate after 6 months, 12 months and 2 years)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Malene Barfod O'Connell

RN, PhD student

Copenhagen University Hospital, Hvidovre

研究点 (2)

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