Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

Официальное название

Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Offer of specialized alcohol use disorder treatment in the hepatology clinic
  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.

Первичные конечные точки

• Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months [Срок оценки: 6 months after baseline]

Вторичные конечные точки (12)

• Self-reported alcohol abstinence in the last 30 days at 3 months followup [Срок оценки: 3 months after baseline]
• Rate of AUD treatment [Срок оценки: 6 and 12 months after baseline]
• Rate of individuel AUD treatment [Срок оценки: 6 and 12 months after baseline]
• Rate of AUD treatment [Срок оценки: 6 and 12 months from baseline]
• Reduction in drinks per week [Срок оценки: 3, 6 and 12 months from baseline]
• Reduction in phosphatidylethanol [Срок оценки: 6 and 12 months from baseline]
• Complications from liver disease [Срок оценки: 3 years from baseline]
• All-cause mortality [Срок оценки: 3 years from baseline]
• Progression of liver disease [Срок оценки: 3 years from baseline]
• Duration of AUD treatment [Срок оценки: 6 and 12 months from baseline]
• Group AUD treatment sessions [Срок оценки: 6 and 12 months from baseline]
• Self-reported abstinence last 30 days after 12 months and phosphatidylethanol level after 12 months [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Department of Medicine, Zealand University Hospital — Køge

Идентификаторы

NCT: NCT06493773 · SJ-895

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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