The Liver Care Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse, Alcoholism, Fibrosis, Liver, Alcohol-Related Disorders

Intervention / Treatment
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* Diagnostic Test: Transient Elastography


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized concealed allocation to intervention or control
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Fibroscan, Liver stiffness measurement, abstinence