Clinical Research Directory
Browse clinical research sites, groups, and studies.
Elastography-based Brief Alcohol Intervention in Hospitalized Individuals
Sponsor: Oslo University Hospital
Summary
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.
Official title: Proactive Liver Disease Assessment and Brief Intervention Among Hospitalized People With Harmful Alcohol Consumption: An Investigator-initiated, Pragmatic, Parallel-group, Open-label, 2-arm Randomized Controlled Trial to Investigate the Efficacy of Proactive Elastography-based Brief Alcohol Intervention Compared With Usual Care in Hospitalized Adult Participants at Risk of Alcohol-related Liver Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-08-15
Completion Date
2038-05-15
Last Updated
2026-06-09
Healthy Volunteers
No
Interventions
Elastography-based brief alcohol intervention
Participants randomized to elastography-based BAI will receive elastography assessment during first hospitalization. Elastography is a widely validated ultrasound-based technique that measures liver stiffness as a surrogate marker of liver fibrosis. The BAI will be delivered according to the FRAMES model, a structured, evidence-based framework for brief motivational interventions targeting harmful alcohol use. The intervention is patient-centered, non-confrontational, and based on principles of motivational interviewing. Both the elastography and the BAI will last approximately 10-15 minutes and will be delivered by trained study personnel directly following elastography assessment. At 3 months, participants will receive BAI by telephone. Follow-up reinforcement of elastography-based BAI will subsequently be provided during scheduled visits at 6 and 12 months.
Locations (8)
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