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临床试验/NCT03267069
NCT03267069招募中不适用

Evaluating Alcohol Use in Alcoholic Liver Disease

Nicole T Shen1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
alcohol recidivism assessed by questionnaire

研究概览

简要总结

This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.

详细描述

This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10 years. Follow-up will consist of a chart review, a phone or in person interview, and most recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded to the survey results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • alcoholic liver disease able to consent

排除标准

  • without alcoholic liver disease unable to consent

结局指标

主要结局

alcohol recidivism assessed by questionnaire

时间窗: 6 months

Follow-up questionnaires will be administered at 6 months assessing for alcohol use

alcohol recidivism assessed by clinical interview

时间窗: 6 months

Follow-up interviews will be conducted at 6 months assessing for alcohol use

alcohol recidivism assessed by urine ethyl glucuronide

时间窗: 6 months

Follow-up urine testing may be conducted at 6 months assessing for alcohol use

alcohol recidivism assessed by blood

时间窗: 6 months

Follow-up blood testing may be conducted at 6 months assessing for alcohol use

次要结局

  • alcohol recidivism assessed by questionnaire(after 6 months)
  • alcohol recidivism assessed by clinical interview(after 6 months)
  • alcohol recidivism assessed by urine ethyl glucuronide(after 6 months)
  • alcohol recidivism assessed by blood(after 6 months)

研究者

发起方
Nicole T Shen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicole T Shen

Gastroenterology and Hepatology Fellow Physician

New York Presbyterian Hospital

研究点 (1)

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Evaluating Alcohol Use in Alcoholic Liver Disease | 临床试验