Elastography-based Brief Alcohol Intervention in Hospitalized Individuals

Sponsor
Oslo University Hospital
Study ID
NCT07637539
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elastography-based brief alcohol intervention — BEHAVIORAL
    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.

Study Details

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 Dates

First listed
Jun 9, 2026
Start date
Aug 15, 2026
Status verified
Jun 2026
Primary completion
May 15, 2030
Completion
May 15, 2038

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual care
    Participants randomized to the usual care arm will recieve standard clinical care as provided during routine hospital practice for inpatients with signs of harmful alcohol use.
  • Active Comparator: Elastography-based brief alcohol intervention
    Participants randomized to the elastography-based brief alcohol intervention groupe, will, in addition to usual care, recieve liver stifness measurements (LSM) and brief alcohol intervention.

Primary Outcome Measure

Number of all-cause emergency hospitalizations [ Time Frame: 24 months after randomization. ]

Central Contacts

Find similar trials

Nationwide
Substance use disorder trialsBehavioral health trialsAddiction medicine trials

Related Studies