Clinical trial NCT06493773: Systematic Referral to Alcohol Use Dependency Treatment in Patients With Alcohol-related Liver Disease: a RCT
Official title: Systematic Referral to Physical and Online Alcohol Use Dependency Treatment in Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases, Alcoholic
Alcohol Use Disorder
Treatment Adherence
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Novavi Køge og Novavi Roskilde (alcohol abuse treatment centres)
name: Center for Clinical Research and Prevention
First posted: 2024-07-10
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria

* Age \> 18 years
* Newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit.
* A liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography.
* Excessive alcohol consumption defined as \>7 units/week for women and \>14 units/week for men within the previous year.
* The patient is able to understand the purpose of the study and give informed oral and written consent to participate.
* No ongoing or recent AUD treatment defined as within 12 months. Only AUD treatment provided by a specialised AUD treatment centre counts as AUD treatment.

Exclusion criteria

* Not enough proficiency in Danish to participate in interviews and questionnaires.
* Pregnancy

Primary outcomes:
measure: Self-reported alcohol abstinence in the last 30 days at 6 months followup
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Self-reported alcohol abstinence in the last 30 days at 3 months followup
timeFrame: 3 months after baseline
measure: Rate of online AUD treatment
timeFrame: 6 months after baseline
measure: Rate of in-person AUD treatment
timeFrame: 6 months after baseline
measure: Rate of AUD treatment
timeFrame: 6 months from baseline
measure: Reduction in drinks per week
timeFrame: 6 months from baseline
measure: Reduction in phosphatidylethanol
timeFrame: 6 months from baseline
measure: Complications from liver disease
timeFrame: 3 years from baseline
measure: All-cause mortality
timeFrame: 3 years from baseline
measure: Progression of liver disease
timeFrame: 3 years from baseline
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Medicine, Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital, Koege
name: Lone G Madsen, PhD
role: STUDY_CHAIR
References: