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.
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
Not speaking Danish or English
Severe liver disease (known by the participant)
Parallel
Transient Elastography
Diagnostic testOne transient elastography 1-2 weeks after randomization
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
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
Improvement or no decrease in motivation to cut down on alcohol (yes or no)
Assessed by telephone interview via questionnaire
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
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
Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan
Click on the lead sponsor to view all of their trials.
Zealand University Hospital
Lead sponsor
Novavi
Collaborator
Aarhus University Hospital
Collaborator
Frederiksberg University Hospital
Collaborator
University of Copenhagen
Collaborator
