Elastography-based Brief Alcohol Intervention in Hospitalized Individuals
Starting soon · Not applicable
Conditions studied: Alcoholic Liver Disease (ALD), Alcohol Use Disorder
In brief
Harmful alcohol use is a common cause of hospital admissions and the leading cause of liver cirrhosis. Timely detection of liver disease is crucial to prevent liver disease progression and reduce alcohol-related harms. The hypothesis is that proactive assessment of liver health during hospitalization may motivate reductions in alcohol use and thereby prevent disease complications and recurrent admissions more effectively than usual care. The study will recruit 500 patients at risk of alcohol-related liver disease who are admitted for inpatient care for any reason. Recruitment will be done at 8 Norwegian hospitals over an 18-month period. Participants will be randomized to liver elastography (liver stiffness measurement) and personalized alcohol counselling, or to usual care. After discharge, participants will be followed with study visits after 3, 6 and 12 months. Assessments during follow-up include self-reported alcohol use, the alcohol biomarker PEth and health-related quality of life. The primary outcome is the number of emergency hospital admissions for any reason within 2 years, collected from the Norwegian Patient Registry. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking.
Key facts
- Study ID
- NCT07637539
- Run by
- Oslo University Hospital
- People needed
- 500
- Starts
- 2026-08-15
- Expected to finish
- 2038-05-15
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Emergency hospitalized for any reason in any participating centre
- Adults 18 years or older
- Harmful alcohol use, defined as AUDIT-C ≥6 (for men) or AUDIT-C ≥5 (for women)
- Moderate to high risk of liver fibrosis, defined as FIB-4 >1.3
- Signed informed consent
You may not qualify if…
- Decompensated liver disease that impedes intervention delivery, defined as one or more of the following:
- Moderate or severe ascites
- Overt hepatic encephalopathy (West Haven grade ≥2)
- Acute-on-chronic liver failure requiring admission to intensive care unit
- Acute hepatitis of any aetiology, defined as ALT or AST >5 x upper limit of normal (ULN)
- Unable to participate for any reason in the opinion of the investigator
Where it is running
- Haraldsplass Deaconess Hospital — Bergen, Norway
- Vestre Viken Bærum Hospital — Drammen, Norway
- Sykehuset Nord-Trøndelag Levanger — Levanger, Norway
- Sykehuset Innlandet Lillehammer — Lillehammer, Norway
- Akershus University Hospital — Lørenskog, Norway
- Diakonhjemmet Hospital — Oslo, Norway
- Lovisenberg Diaconal Hospital — Oslo, Norway
- Oslo University Hospital — Oslo, Norway
Full record on ClinicalTrials.gov
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