Evaluating Alcohol Use in Alcoholic Liver Disease

Recruiting

• Conditions: Alcoholic Liver Disease
• Interventions: Other: survey

• Registration Number: NCT03267069
• Lead Sponsor: Nicole T Shen

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-11-27
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• alcoholic liver disease able to consent

Exclusion Criteria

• without alcoholic liver disease unable to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
alcohol liver disease	survey	Patients with alcohol liver disease consenting to participate in the study will be administered an initial survey at inclusion and then follow-up surveys at 3, 6, 9, 12, 15, and 18 month intervals and then 2, 5, and 10 years. There is no intervention cohort, all enrolled will complete the same surveys. Recidivism will be measured by responses to survey questions, clinical interviews documented in the chart, and urine ethnyl glucuronide or blood ethanol testing.

Primary Outcome Measures

Name	Time	Method
alcohol recidivism assessed by questionnaire	6 months	Follow-up questionnaires will be administered at 6 months assessing for alcohol use
alcohol recidivism assessed by clinical interview	6 months	Follow-up interviews will be conducted at 6 months assessing for alcohol use
alcohol recidivism assessed by urine ethyl glucuronide	6 months	Follow-up urine testing may be conducted at 6 months assessing for alcohol use
alcohol recidivism assessed by blood	6 months	Follow-up blood testing may be conducted at 6 months assessing for alcohol use

Secondary Outcome Measures

Name	Time	Method
alcohol recidivism assessed by urine ethyl glucuronide	after 6 months	Follow-up urine testing may be conducted after 6 months assessing for alcohol use
alcohol recidivism assessed by questionnaire	after 6 months	Follow-up questionnaires will be administered after 6 months assessing for alcohol use
alcohol recidivism assessed by clinical interview	after 6 months	Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use
alcohol recidivism assessed by blood	after 6 months	Follow-up blood testing may be conducted after 6 months assessing for alcohol use

Trial Locations

Locations (1)

New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center; 🇺🇸 New York, New York, United States