Evaluating Alcohol Use in Alcoholic Liver Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Alcoholic Liver Disease
• Intervention / Treatment: Other: survey

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Nicole T Shen, MD; Phone Number: 3146095911; Email: nts9004@nyp.org
• Study Contact Backup: Name: Robert S Brown, MD, MPH; Phone Number: (646) 962-5483; Email: rsb2005@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
      • Contact: Nicole T Shen, MD; Phone Number: 314-609-5911; Email: nts9004@nyp.org
      • Contact: Cecilia M Mero; Phone Number: (646) 962-9358; Email: cmm2002@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

subjects with alcoholic liver disease

Description

Inclusion Criteria:

• alcoholic liver disease able to consent

Exclusion Criteria:

• without alcoholic liver disease unable to consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

alcohol liver disease; 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.

Other: survey; surveys will be administered at inclusion and follow-ups

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nicole T Shen
• Investigators: Principal Investigator: Robert S Brown, MD, MPH, New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2016
• Primary Completion (Anticipated): November 1, 2026
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol-Induced Disorders; Liver Diseases; Liver Diseases, Alcoholic
• Other Study ID Numbers: 1601016922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No