Evaluating Alcohol Use in Alcoholic Liver Disease

Nicole T Shen

Status: Enrolling

Conditions: Alcoholic Liver Disease

Treatments: Other: survey

Study type: Observational

Funder types: Other

Identifiers

NCT03267069

1601016922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• alcoholic liver disease able to consent

Exclusion criteria

• without alcoholic liver disease unable to consent

Trial design

160 participants in 1 patient group

alcohol liver disease

Description:

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.

Treatment:

Other: survey