The Liver Care Trial: Screening for Liver Disease in Individuals Attending Treatment for Alcohol Use Disorder - a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcoholic Liver Disease
- Sponsor
- Zealand University Hospital
- Enrollment
- 408
- Locations
- 2
- Primary Endpoint
- Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization
Time Frame: Assessed 6 months after randomization
Assessed By telephone interview or health record
Secondary Outcomes
- Heavy drinking days last 30 days(Assessed 6 months after since randomization)
- Change in AUDIT-C score (yes or no) since randomization(6 months after randomization)