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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Novavi Køge
RECRUITING
Køge
Novavi Roskilde
RECRUITING
Roskilde
Contact Information
Primary
Pernille Dahlin, MD
pedah@regionsjaelland.dk
+45 30291114
Backup
Gro Askgaard, PHD
gras@regionsjaelland.dk
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 408
Treatments
Experimental: Intervention
An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease.
No_intervention: Control
An invitation to screening by blood sampling with Fib-4
Related Therapeutic Areas
Sponsors
Collaborators: Frederiksberg University Hospital, University of Copenhagen, Aarhus University Hospital, Novavi
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov