Clinical trial NCT05855031: 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
Overall status: RECRUITING
Phase: NA
Conditions: Alcoholic Liver Disease
Alcohol Use Disorder
Alcohol Abuse
Alcoholism
Fibrosis, Liver
Alcohol-Related Disorders
Keywords: Screening
Fibroscan
Liver stiffness measurement
abstinence
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Novavi
name: Aarhus University Hospital
name: Frederiksberg University Hospital
name: University of Copenhagen
First posted: 2023-05-11
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized concealed allocation to intervention or control
Primary purpose: SCREENING

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.


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)

Primary outcomes:
measure: Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization
timeFrame: Assessed 6 months after randomization
Secondary outcomes:
measure: Heavy drinking days last 30 days
timeFrame: Assessed 6 months after since randomization
measure: Change in AUDIT-C score (yes or no) since randomization
timeFrame: 6 months after randomization
Other outcomes:
measure: Improvement or no decrease in motivation to cut down on alcohol (yes or no)
timeFrame: 6 months after randomization
measure: 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.
timeFrame: Assessed 6 months after randomization
measure: 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.
timeFrame: Assessed 6 months after randomization
measure: Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan
timeFrame: Assessed 6 months after randomization
measure: Improvement or no decrease in smoking (yes/no)
timeFrame: Assessed 6 months after randomization
Locations:
city: Køge
country: Denmark
facility: Novavi Køge
city: Roskilde
country: Denmark
facility: Novavi Roskilde
Study officials:
affiliation: Zealand University Hospital
name: Gro Askgaard, PHD
role: PRINCIPAL_INVESTIGATOR
References: