Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
This pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.
详细描述
Alcohol-related liver disease (ALD) is responsible for about 80% of all liver disease in Denmark. The prognosis for ALD is good, if detected early and abstinence is obtained. Unfortunately ALD is often diagnosed at a late state and the 1-year survival is only 30%.
Currently there is no available systematic screening for fibrosis/cirrhosis among patients with longterm abuse of alcohol and thereby high risk for developing ALD.
Transient elastography (TE) is a non-invasive, risk free and quick method of detecting fibrosis. TE is validated for diagnosing fibrosis and ruling out cirrhosis.
40 patients will be enrolled in the study with a 1:1 randomization. Baseline data is collected and informed concent is obtained at the local alcohol abuse treatment center, Novavi Køge. The fibroscan and blood samples are done at Zealand University Hospital, Køge. Follow-up is done after 6 months, by a project nurse, blinded to the intervention.
If the study proves to be feasible, our aim is to extend the study in order to investigate wether the interventions described above, could help decrease alcohol consumption/maintain abstinence for patients in alcohol treatment. Moreover the prevalence of fibrosis and cirrhosis found by fibroscan is examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •must be enrolled at alcohol treatment center Novavi Koege, Denmark
- •Maximum 6 months of treatment at Novavi Koege
排除标准
- •known severe liver disease
- •life expectancy less than 6 months
- •unable to give informed written consent
结局指标
主要结局
Retention
时间窗: 6 months
\>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
Completion
时间窗: 6 months after randomization
\>50% of randomized patients complete follow-up
Recruitment
时间窗: 6 months
\>50% of those invited to participate gives written consent.
次要结局
- Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment(6 months)
- Abstinence or reduction in alcohol consumption(10 months)
- Reduction in AUDIT score(10 months)
- Reduction in Number of heavy drinking days(10 months)