Elastography-based Brief Alcohol Intervention in Hospitalized Individuals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Elastography-based brief alcohol intervention

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators