The Liver Care Trial

Sponsor

Zealand University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05855031

Collaborator

Novavi (Other), Aarhus University Hospital (Other), Frederiksberg University Hospital (Other), University of Copenhagen (Other)

408

Enrollment

Locations

Arms

47.8

Anticipated Duration (Months)

204

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Liver Disease Alcohol Use Disorder Alcohol Abuse Alcoholism Fibrosis, Liver Alcohol-Related Disorders	Diagnostic Test: Transient Elastography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

408 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized concealed allocation to intervention or controlRandomized concealed allocation to intervention or control

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

May 8, 2023

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention

An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.

Diagnostic Test: Transient Elastography

One transient elastography 1-2 weeks after randomization

Other Names:

Fibroscan

Liver stiffness measurement

No Intervention: Control

An invitation to screening by blood sampling with Fib-4

Outcome Measures

Primary Outcome Measures

Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization [Assessed 6 months after randomization]
Assessed By telephone interview or health record

Secondary Outcome Measures

Heavy drinking days last 30 days [Assessed 6 months after since randomization]
Assessed by telephone interview or health record
Change in AUDIT-C score (yes or no) since randomization [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 Outcome Measures

Improvement or no decrease in motivation to cut down on alcohol (yes or no) [6 months after randomization]
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. [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
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. [Assessed 6 months after randomization]
Light consumption < 10 units/week
Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan [Assessed 6 months after randomization]
Improvement or no decrease in smoking (yes/no) [Assessed 6 months after randomization]
By logistic regression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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