Skip to main content
Clinical Trials/NCT04158986
NCT04158986
Completed
N/A

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

Copenhagen University Hospital, Hvidovre1 site in 1 country110 target enrollmentDecember 1, 2019
ConditionsLiver Cirrhosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
Copenhagen University Hospital, Hvidovre
Enrollment
110
Locations
1
Primary Endpoint
Time from discharge to first readmission.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
October 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copenhagen University Hospital, Hvidovre
Responsible Party
Principal Investigator
Principal Investigator

Malene Barfod O'Connell

RN, PhD student

Copenhagen University Hospital, Hvidovre

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Time from discharge to first readmission.

Time Frame: 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

Time Frame: Duration of readmissions due to liver cirrhosis in the 6 month trial time.

Duration of readmissions due to liver cirrhosis

Number of readmissions

Time Frame: Number of readmissions within 2 years.

Number of readmissions within 2 years

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials