Systematic Referral to Alcohol Use Dependency Treatment in Patients With Alcohol-related Liver Disease: a RCT
- Conditions
- Liver Diseases, AlcoholicTreatment AdherenceAlcohol Use Disorder
- Interventions
- Behavioral: Offer of referral to specialized alcohol use disorder treatment
- Registration Number
- NCT06493773
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
To evaluate the efficacy of systematically referring newly diagnosed ALD patients to AUD treatment 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 referral to specialized AUD treatment (intervention) and B) standard care (control). The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.
- Detailed Description
The investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering AUD treatment in 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 = 70). Please see Figure 1 for the flow of participants in the study. From June 24, 2024, 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 referral to AUD treatment, which includes contact from the AUD treatment center to the patients and the offer of both physical and online AUD treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 203
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Offer of referral to specialized alcohol use disorder treatment Patients randomized to the intervention group.
- Primary Outcome Measures
Name Time Method Self-reported alcohol abstinence in the last 30 days at 6 months followup 6 months after baseline 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), measurement of phosphatidylethanol, and review of electronic medical records.
- Secondary Outcome Measures
Name Time Method Rate of in-person AUD treatment 6 months after baseline Any in-person treatment for alcohol use disorder after 6 months
Reduction in phosphatidylethanol 6 months from baseline Reduction in phosphatidylethanol value at 6 months compared to baseline (yes or no)
Self-reported alcohol abstinence in the last 30 days at 3 months followup 3 months after baseline Self-reported alcohol abstinence (defined as zero consumption of alcohol) throughout the last 30 days assessed after 3 months assessed by the timeline followback method (questionnaire) and review of electronic medical records.
Rate of online AUD treatment 6 months after baseline Any online treatment for alcohol use disorder after 6 months
Rate of AUD treatment 6 months from baseline Number of received sessions of treatment for alcohol use disorder after 6 months
Reduction in drinks per week 6 months from baseline Reduction in drinks per week after 3 and 6 months compared to baseline (yes or no)
Complications from liver disease 3 years from baseline 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
Progression of liver disease 3 years from baseline 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
All-cause mortality 3 years from baseline time to death
Trial Locations
- Locations (1)
Department of Medicine, Zealand University Hospital
🇩🇰Køge, Denmark