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Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis (NurseAID)

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nurse-driven post-discharge intervention
Sponsored by
Copenhagen University Hospital, Hvidovre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Copenhagen University Hospital, Amager Hvidovre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard treatment

Nurse-driven post-discharge intervention

Arm Description

Receives standard post-discharge care with planned follow-up in the clinic for liver failure or ambulatory.

Participates in a nurse-driven post-discharge intervention program.

Outcomes

Primary Outcome Measures

Time from discharge to first readmission.
Time from discharge to first readmission.
Number of readmissions
Number of readmissions within 2 years
Duration of readmissions
Duration of readmissions due to liver cirrhosis

Secondary Outcome Measures

Health related quality of life before and after intervention
Measured by the Chronic Liver Disease Questionnaire (CLDQ), which comprises 29 questions split into six domains. Domain scores and an overall score are presented on a 1-7 scale. Higher scores represents better HRQOL.
Self-perceived health before and after intervention
Measured by SF-12v2ยฎ Health Survey Acute, Denmark (Danish), which comprises 12 questions split into seven domains. Higher scores represents worse self-perceived health.
Functional disability in work-, social-, and family life before and after intervention
Measured by the Sheehan Disability Scale (SDS), which comprises three questions with scales from 0-10. Higher scores represents worse functional ability.
Mortality
Mortality after 6 months, 12 months and 2 years

Full Information

First Posted
October 23, 2019
Last Updated
December 29, 2022
Sponsor
Copenhagen University Hospital, Hvidovre
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1. Study Identification

Unique Protocol Identification Number
NCT04158986
Brief Title
Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis
Acronym
NurseAID
Official Title
Post-discharge Nurse-driven Intervention Program for Patients With Decompensated Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
October 13, 2021 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Allocation is blinded.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Receives standard post-discharge care with planned follow-up in the clinic for liver failure or ambulatory.
Arm Title
Nurse-driven post-discharge intervention
Arm Type
Experimental
Arm Description
Participates in a nurse-driven post-discharge intervention program.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-driven post-discharge intervention
Intervention Description
Home visits based on the concepts of Family Nursing: The participants will receive three home visits by a nurse who is trained in the Family Nursing principles during the first 12 weeks after discharge. The home visits will comprise of: Filling in the Chronic Liver Disease Questionnaire. Therapeutic conversations including drawing and review of genogram and eco-map. Information about- and help to initiate contact to relevant municipal offers. Evidence-based information based on the patient's current problems or symptoms, base-line knowledge and receptiveness. Follow-up telephone calls: โ€ข After the first 12 weeks participants will be followed-up by telephone monthly during the following 12 weeks. Pamphlet: โ€ข All participants will receive a pamphlet with brief information regarding preventive measures and early signs of decompensation as well as relevant contact details. The pamphlet will be handed out before discharge
Primary Outcome Measure Information:
Title
Time from discharge to first readmission.
Description
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.
Title
Number of readmissions
Description
Number of readmissions within 2 years
Time Frame
Number of readmissions within 2 years.
Title
Duration of readmissions
Description
Duration of readmissions due to liver cirrhosis
Time Frame
Duration of readmissions due to liver cirrhosis in the 6 month trial time.
Secondary Outcome Measure Information:
Title
Health related quality of life before and after intervention
Description
Measured by the Chronic Liver Disease Questionnaire (CLDQ), which comprises 29 questions split into six domains. Domain scores and an overall score are presented on a 1-7 scale. Higher scores represents better HRQOL.
Time Frame
The change in health related quality of life before and after intervention (6 months trial time).
Title
Self-perceived health before and after intervention
Description
Measured by SF-12v2ยฎ Health Survey Acute, Denmark (Danish), which comprises 12 questions split into seven domains. Higher scores represents worse self-perceived health.
Time Frame
The change in self-perceived health before and after intervention (6 months trial time).
Title
Functional disability in work-, social-, and family life before and after intervention
Description
Measured by the Sheehan Disability Scale (SDS), which comprises three questions with scales from 0-10. Higher scores represents worse functional ability.
Time Frame
The change in functional disability in work-, social-, and family life before and after intervention (6 months trial time)
Title
Mortality
Description
Mortality after 6 months, 12 months and 2 years
Time Frame
The mortality rate after 6 months, 12 months and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malene Barfod O'Connell, RN, MScPH
Organizational Affiliation
Amager Hvidovre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital, Amager Hvidovre
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

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