Alcoholic Liver Disease, Alcohol Use Disorder, Alcohol Abuse, Alcoholism, Fibrosis, Liver, Alcohol-Related Disorders
Conditions
Keywords
Screening, Fibroscan, Liver stiffness measurement, abstinence
Brief 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.
Interventions
DIAGNOSTIC_TESTTransient Elastography
One transient elastography 1-2 weeks after randomization
Sponsors
Novavi
Aarhus University Hospital
Frederiksberg University Hospital
University of Copenhagen
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
Randomized concealed allocation to intervention or control
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Not speaking Danish or English * Severe liver disease (known by the participant)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization | Assessed 6 months after randomization | Assessed By telephone interview or health record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heavy drinking days last 30 days | Assessed 6 months after since randomization | Assessed by telephone interview or health record |
| Change in AUDIT-C score (yes or no) since randomization | 6 months after randomization | AUDIT: the Alcohol Use Disorders Identification Test is a validated manual for use in primary care to identify persons with hazardous and harmful patterns of alcohol consumption |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparing alcohol consumption amount between those with a positive fibroscan vs. those with a negative fibroscan | Assessed 6 months after randomization | — |
| Improvement or no decrease in motivation to cut down on alcohol (yes or no) | 6 months after randomization | Assessed by telephone interview via questionnaire |
| Improvement or no decrease in smoking (yes/no) | Assessed 6 months after randomization | By logistic regression |
| Improvement or no decrease in physical and mental health-related quality of life (SF-12) (yes or no), calculated as the difference between baseline and follow-up. | Assessed 6 months after randomization | SF 12 (12-Item Short Form Survey) is a validated self-reported outcome measure assessing the impact of health on an individual's everyday life |
| Comparing abstinence or light consumption last 30 days between those in the intervention group with a screen negative result with those in the control group. | Assessed 6 months after randomization | Light consumption \< 10 units/week |
Countries
Denmark
Contacts
Primary ContactPernille Dahlin, MD
Backup ContactGro Askgaard, PHD
Outcome results
None listed