Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05855031

The Liver Care Trial

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alcoholic Liver Disease Alcohol Abuse Alcohol Use Disorder Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Digestive System Diseases Fibrosis Fibrosis, Liver Liver Cirrhosis Liver Diseases Liver Diseases, Alcoholic Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novavi Køge, Køge, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transient elastography

Diagnostic Test

One transient elastography 1-2 weeks after randomization

Other names: Fibroscan, Liver stiffness measurement

Primary outcomes

  1. 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

  1. Heavy drinking days last 30 days

    Time frame: Assessed 6 months after since randomization

    Assessed by telephone interview or health record

  2. Change in AUDIT-C score (yes or no) since randomization

    Time frame: 6 months after 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

Other outcomes

  1. Improvement or no decrease in motivation to cut down on alcohol (yes or no)

    Time frame: 6 months after randomization

    Assessed by telephone interview via questionnaire

  2. 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.

    Time frame: Assessed 6 months after randomization

    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

  3. 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.

    Time frame: Assessed 6 months after randomization

    Light consumption < 10 units/week

  4. Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan

    Time frame: Assessed 6 months after randomization

  5. Improvement or no decrease in smoking (yes/no)

    Time frame: Assessed 6 months after randomization

    By logistic regression

Study contacts

Contact information is provided by the study sponsor or research team.

Gro Askgaard, PHD

CONTACT

[email protected]

Pernille Dahlin, MD

CONTACT

[email protected]

+45 30291114

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Frederiksberg University Hospital
  • Novavi
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 11, 2023
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.