The Liver Care Trial

The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Alcoholism; Alcohol-Related Disorders; Fibrosis, Liver; Alcohol Use Disorder; Alcoholic Liver Disease; Alcohol Abuse
• Intervention / Treatment: Diagnostic test: Transient Elastography

• Study Type: Interventional
• Enrollment (Anticipated): 408
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pernille Dahlin, MD; Phone Number: +45 30291114; Email: pedah@regionsjaelland.dk
• Study Contact Backup: Name: Gro Askgaard, PHD; Email: gras@regionsjaelland.dk

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Recruiting
    • Novavi Køge
    • Contact: Pernille Dahlin, MD; Phone Number: 30291114; Email: pedah@regionsjaelland.dk
  • Roskilde, Denmark, 4000
    • Recruiting
    • Novavi Roskilde
    • Contact: Pernille Dahlin, MD; Phone Number: 30291114; Email: pedah@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.	Diagnostic test: Transient Elastography; One transient elastography 1-2 weeks after randomization; Other Names: Fibroscan; Liver stiffness measurement
No Intervention: Control; An invitation to screening by blood sampling with Fib-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed 6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heavy drinking days last 30 days	Assessed by telephone interview or health record	Assessed 6 months after since randomization
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	6 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement or no decrease in motivation to cut down on alcohol (yes or no)	Assessed by telephone interview via questionnaire	6 months after randomization
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.	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	Assessed 6 months after randomization
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.	Light consumption < 10 units/week	Assessed 6 months after randomization
Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan		Assessed 6 months after randomization
Improvement or no decrease in smoking (yes/no)	By logistic regression	Assessed 6 months after randomization

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Collaborators: Aarhus University Hospital; University of Copenhagen; Frederiksberg University Hospital; Novavi
• Investigators: Principal Investigator: Gro Askgaard, PHD, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Anticipated): November 1, 2026
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Screening; abstinence; Fibroscan; Liver stiffness measurement
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; Drinking Behavior; Substance-Related Disorders; Fibrosis; Alcohol-Induced Disorders; Liver Diseases; Alcohol Drinking; Alcoholism; Disease; Liver Cirrhosis; Alcohol-Related Disorders; Liver Diseases, Alcoholic
• Other Study ID Numbers: SJ-995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No