Alcohol Misuse Treatment Delivered in the Hepatology Clinic to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Self-reported alcohol abstinence in the last 30 days at 6 months followup in combination with phosphatidylethanol level at 6 months
时间窗: 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) and review of medical charts and measurement of phosphatidylethanol at 6 months
次要结局
- Self-reported alcohol abstinence in the last 30 days at 3 months followup(3 months after baseline)
- Complications from liver disease(3 years from baseline)
- Progression of liver disease(3 years from baseline)
- Rate of AUD treatment(6 and 12 months from baseline)
- Self-reported alcohol abstinence in the last 30 days at 3 months followup(3 months after baseline)
- Reduction in drinks per week(3, 6 and 12 months from baseline)
- Progression of liver disease(3 years from baseline)
- Rate of individuel AUD treatment(6 and 12 months after baseline)
- Complications from liver disease(3 years from baseline)
- Reduction in phosphatidylethanol(6 and 12 months from baseline)
- All-cause mortality(3 years from baseline)
- Duration of AUD treatment(6 and 12 months from baseline)
- 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(12 months)