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| Name | Class |
|---|---|
| Novavi | UNKNOWN |
| Aarhus University Hospital | OTHER |
| Frederiksberg University Hospital | OTHER |
| University of Copenhagen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | An invitation to a liver stiffness measurement (Transient Elastography), to blood sampling and a leaflet on alcohol-related disease. |
|
| Control | No Intervention | An invitation to screening by blood sampling with Fib-4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient Elastography | Diagnostic Test | One transient elastography 1-2 weeks after randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol abstinence or light consumption (≤ 10 units/week) the last 30 days (yes/no) assessed 6 months since randomization | Assessed By telephone interview or health record | Assessed 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Heavy drinking days last 30 days | Assessed by telephone interview or health record | Assessed 6 months after since randomization |
| Change in AUDIT-C score (yes or no) since 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement or no decrease in motivation to cut down on alcohol (yes or no) | Assessed by telephone interview via questionnaire | 6 months after randomization |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pernille Dahlin, MD | Contact | +45 30291114 | pedah@regionsjaelland.dk | |
| Gro Askgaard, PHD | Contact | gras@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Gro Askgaard, PHD | Zealand University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novavi Køge | Recruiting | Køge | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41152905 | Derived | Dahlin P, Jepsen P, Molzen L, Madsen LG, Wegmann During S, Benthien KS, Winther-Jensen M, Grew JC, Kirk JW, Jensen KJ, Petersen J, Askgaard G. The Liver Care Trial: screening for liver disease in individuals attending treatment for alcohol use disorder-study protocol for a randomized controlled study. Trials. 2025 Oct 28;26(1):448. doi: 10.1186/s13063-025-09151-8. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 5, 2023 | May 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2023 | May 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| D000437 | Alcoholism |
| D008103 | Liver Cirrhosis |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019966 | Substance-Related Disorders |
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| OTHER |
Randomized concealed allocation to intervention or control
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| 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 |
| Assessed 6 months after randomization |
| 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. | Light consumption < 10 units/week | Assessed 6 months after randomization |
| 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 smoking (yes/no) | By logistic regression | Assessed 6 months after randomization |
| Novavi Roskilde | Recruiting | Roskilde | 4000 | Denmark |
|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |