Referral to alcohol treatment for patients with liver disease
Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
This study tests whether sending newly diagnosed patients with alcohol-related liver disease to specialized treatment can help them stop drinking better than just regular care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 221 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Køge, Køge) |
| Trial ID | NCT06493773 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of systematically referring newly diagnosed patients with alcohol-related liver disease (ALD) to specialized alcohol use disorder (AUD) treatment. It is a randomized controlled trial comparing the outcomes of patients receiving standard care versus those receiving standard care plus a referral to AUD treatment. The primary goal is to assess the rate of alcohol abstinence after six months. Participants will be randomized during their first visit, and the study will utilize an existing observational cohort for control comparisons.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old, newly diagnosed with alcohol-related liver disease, and consuming excessive alcohol.
Not a fit: Patients who are currently undergoing AUD treatment or those who do not speak Danish may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the rates of alcohol abstinence in patients with alcohol-related liver disease.
How similar studies have performed: Other studies have shown promising results in improving treatment adherence and outcomes for patients with alcohol use disorders, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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. Exclusion criteria * Not enough proficiency in Danish to participate in interviews and questionnaires. * Pregnancy * Ongoing specialized AUD treatment. Self-help groups and AUD counselling at general practitioners are not counting as specialized AUD treatment in this study.
Where this trial is running
Køge, Køge
- Department of Medicine, Zealand University Hospital — Køge, Køge, Denmark (Recruiting)
Study contacts
- Study coordinator: Emil B B Fromberg, Cand.scient.san
- Email: ebuf@regionsjaelland.dk
- Phone: 51184036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.