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The Liver Care Trial

Primary Purpose

Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transient Elastography
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Alcoholic Liver Disease focused on measuring Screening, Fibroscan, Liver stiffness measurement, abstinence

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde Informed written consent Exclusion Criteria: Not speaking Danish or English Severe liver disease (known by the participant)

Sites / Locations

  • Novavi KøgeRecruiting
  • Novavi RoskildeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.

An invitation to screening by blood sampling with Fib-4

Outcomes

Primary Outcome Measures

Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization
Assessed By telephone interview or health record

Secondary Outcome Measures

Heavy drinking days last 30 days
Assessed by telephone interview or health record
Change in AUDIT-C score (yes or no) since randomization
AUDIT: the Alcohol Use Disorders Identification Test is a validated manual for use in primary care to identify persons with hazardous and harmful patterns of alcohol consumption

Full Information

First Posted
April 20, 2023
Last Updated
May 15, 2023
Sponsor
Zealand University Hospital
Collaborators
Novavi, Aarhus University Hospital, Frederiksberg University Hospital, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05855031
Brief Title
The Liver Care Trial
Official Title
The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
Novavi, Aarhus University Hospital, Frederiksberg University Hospital, University of Copenhagen

4. Oversight

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

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the efficacy of screening for liver disease with liver stiffness measurement on abstinence or light consumption after 6 months in individuals who are receiving treatment for alcohol use disorder and without a history of liver disease. The investigators will conduct a randomized controlled trial with concealed allocation comparing A) an invitation to a liver stiffness measurement, blood sampling and leaflet on alcohol-related disease (intervention) with B) an invitation to blood sampling (control). The primary outcome is 'abstinence or light consumption' (≤ 10 units/week) throughout the last months, and assessed 6 months after randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse, Alcoholism, Fibrosis, Liver, Alcohol-Related Disorders
Keywords
Screening, Fibroscan, Liver stiffness measurement, abstinence

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized concealed allocation to intervention or control
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.
Arm Title
Control
Arm Type
No Intervention
Arm Description
An invitation to screening by blood sampling with Fib-4
Intervention Type
Diagnostic Test
Intervention Name(s)
Transient Elastography
Other Intervention Name(s)
Fibroscan, Liver stiffness measurement
Intervention Description
One transient elastography 1-2 weeks after randomization
Primary Outcome Measure Information:
Title
Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization
Description
Assessed By telephone interview or health record
Time Frame
Assessed 6 months after randomization
Secondary Outcome Measure Information:
Title
Heavy drinking days last 30 days
Description
Assessed by telephone interview or health record
Time Frame
Assessed 6 months after since randomization
Title
Change in AUDIT-C score (yes or no) since randomization
Description
AUDIT: the Alcohol Use Disorders Identification Test is a validated manual for use in primary care to identify persons with hazardous and harmful patterns of alcohol consumption
Time Frame
6 months after randomization
Other Pre-specified Outcome Measures:
Title
Improvement or no decrease in motivation to cut down on alcohol (yes or no)
Description
Assessed by telephone interview via questionnaire
Time Frame
6 months after randomization
Title
Improvement or no decrease in physical and mental health-related quality of life (SF-12) (yes or no), calculated as the difference between baseline and follow-up.
Description
SF 12 (12-Item Short Form Survey) is a validated self-reported outcome measure assessing the impact of health on an individual's everyday life
Time Frame
Assessed 6 months after randomization
Title
Comparing abstinence or light consumption last 30 days between those in the intervention group with a screen negative result with those in the control group.
Description
Light consumption < 10 units/week
Time Frame
Assessed 6 months after randomization
Title
Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan
Time Frame
Assessed 6 months after randomization
Title
Improvement or no decrease in smoking (yes/no)
Description
By logistic regression
Time Frame
Assessed 6 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Attending outpatient treatment for alcohol use disorder (international classification of disease version 10: F102: alcohol dependence or F101: harmful alcohol use) at Novavi Køge or Novavi Roskilde Informed written consent Exclusion Criteria: Not speaking Danish or English Severe liver disease (known by the participant)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pernille Dahlin, MD
Phone
+45 30291114
Email
pedah@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Gro Askgaard, PHD
Email
gras@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gro Askgaard, PHD
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novavi Køge
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pernille Dahlin, MD
Phone
30291114
Email
pedah@regionsjaelland.dk
Facility Name
Novavi Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pernille Dahlin, MD
Phone
30291114
Email
pedah@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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The Liver Care Trial

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