The Liver Care Trial

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder; Alcohol Abuse; Alcoholism; Fibrosis, Liver; Alcohol-Related Disorders; Alcoholic Liver Disease
• Interventions: Diagnostic Test: Transient Elastography

• Registration Number: NCT05855031
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-20
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-02
• Study Start: 2023-05-08
• Study First Posted: 2023-05-11
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17
• Primary Completion: 2026-11-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 408

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Novavi Køge; 🇩🇰 Køge, Denmark

Novavi Roskilde; 🇩🇰 Roskilde, Denmark