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| Name | Class |
|---|---|
| Center for Clinical Research and Prevention | NETWORK |
| Novavi Outpatient Clinics | UNKNOWN |
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To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.
The investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering AUD treatment in the hepatology clinic to newly diagnosed ALD patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care. The study will be embedded in an existing observational cohort from which already included participants will be used as controls in the RCT (n = 89). Please see Figure 1 for the flow of participants in the study. From november, 2025, the investigators will start to randomize eligible participants.
Randomization will take place in connection with the first visit in the observational cohort study. Study participants randomized as controls will receive standard care through their treating physicians, which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation.
Patients in the intervention group will receive standard care in addition to an offer of AUD treatment in the hepatology clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care group | No Intervention | Patients randomized to standard care will receive standard supporting care by their care providers, entailing education on the nature of alcohol-related liver disease and encouragement to abstain from alcohol use. | |
| Intervention group | Experimental | Patients randomized to the intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Offer of specialized alcohol use disorder treatment in the hepatology clinic | Behavioral | Patients are offered specialized alcohol use disorder treatment in the hepatology clinic by an experienced AUD therapist from the AUD facility. Also medical AUD treatments will be offered to support abstinence. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months | Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 6 months assessed by the timeline followback method (questionnaire) and review of medical charts and measurement of phosphatidylethanol at 6 months | 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported alcohol abstinence in the last 30 days at 3 months followup | Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 3 months and no indications of alcohol use in medical charts. | 3 months after baseline |
| Rate of AUD treatment |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emil B B Fromberg, Cand.scient.san | Contact | 51184036 | +45 | ebuf@regionsjaelland.dk |
| Gro Askgaard, PhD | Contact | 60142280 | +45 | gras@regionsjaelland.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lone G Madsen, PhD | Zealand University Hospital, Koege | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Zealand University Hospital | Recruiting | Køge | Køge | 4600 | Denmark |
Because of the relatively low number of patients, data are considered highly sensitive and cannot allow sharing
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2025 |
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There is follow-up for each individual participant conducted by personnel blinded to the randomization and consisting of: 1) telephone contact with interview about alcohol consumption using the time-line follow-back method conducted at three time points after 1, 3 and 6 months, 2) measurement of phosphatidyl ethanol after 6 months, and 3) electronic health records from hospital and alcohol treatment facility after 6 months.
Use of hypothesis blinding for patients about the study aim. Usual care providers in the hospital such as physicians and nurses will not see any description of AUD treatment in the medical charts.
Analyses will be performed in a blinded data set with treatment allocation labeled "A" and "B". Prior to this, the statistical analysis plan will be completed, signed, and uploaded at clinicaltrials.gov, and the data set will be locked. Unblinding will not occur until all analyses are performed (expected autumn 2028).
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Any treatment for alcohol use disorder after 6 and 12 months |
| 6 and 12 months after baseline |
| Rate of individuel AUD treatment | Any individuel treatment for alcohol use disorder after 6 and 12 months | 6 and 12 months after baseline |
| Rate of AUD treatment | Number of received sessions of treatment for alcohol use disorder after 6 and 12 months | 6 and 12 months from baseline |
| Reduction in drinks per week | Reduction in drinks per week after 3, 6 and 12 months compared to baseline (yes or no) | 3, 6 and 12 months from baseline |
| Reduction in phosphatidylethanol | Reduction in phosphatidylethanol value at 6 and 12 months compared to baseline (yes or no) | 6 and 12 months from baseline |
| Complications from liver disease | Time to first decompensation event, which is defined as variceal haemorrhage, ascites grade 2 or worse, or hepatic encephalopathy West-Haven grade 2 or worse | 3 years from baseline |
| All-cause mortality | time to death | 3 years from baseline |
| Progression of liver disease | Progression in liver fibrosis grade assessed by transient elastography or progression to a worse Child-Pugh class (A to B or C and B to C | 3 years from baseline |
| Duration of AUD treatment | Duration of AUD treatment | 6 and 12 months from baseline |
| Group AUD treatment sessions | Amount of group AUD treatment sessions | 6 and 12 months from baseline |
| Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months | Self-reported alcohol abstinence last 30 days by 12 months assessed by the timeline followback method (questionnaire) and review of electronic medical records in combination with measured phosphatidylethanol level. | 12 months |
| Nov 14, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| D000437 | Alcoholism |
| D000074822 | Treatment Adherence and Compliance |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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