Evaluating Alcohol Use in Alcoholic Liver Disease

Alcoholic Liver Disease Clinical Trial

Official title:

Evaluating Alcohol Use in Alcoholic Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03267069
• Other study ID #: 1601016922
• Status: Recruiting
• Start date: November 27, 2016
• Est. completion date: November 1, 2027

Study information

• Verified date: March 2019
• Source: New York Presbyterian Hospital
• Contact: Nicole T Shen, MD
• Phone: 3146095911
• Email: nts9004[@]nyp.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• alcoholic liver disease able to consent

Exclusion Criteria:

• without alcoholic liver disease unable to consent

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

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

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nicole T Shen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alcohol recidivism assessed by questionnaire	Follow-up questionnaires will be administered at 6 months assessing for alcohol use	6 months
Primary	alcohol recidivism assessed by clinical interview	Follow-up interviews will be conducted at 6 months assessing for alcohol use	6 months
Primary	alcohol recidivism assessed by urine ethyl glucuronide	Follow-up urine testing may be conducted at 6 months assessing for alcohol use	6 months
Primary	alcohol recidivism assessed by blood	Follow-up blood testing may be conducted at 6 months assessing for alcohol use	6 months
Secondary	alcohol recidivism assessed by questionnaire	Follow-up questionnaires will be administered after 6 months assessing for alcohol use	after 6 months
Secondary	alcohol recidivism assessed by clinical interview	Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use	after 6 months
Secondary	alcohol recidivism assessed by urine ethyl glucuronide	Follow-up urine testing may be conducted after 6 months assessing for alcohol use	after 6 months
Secondary	alcohol recidivism assessed by blood	Follow-up blood testing may be conducted after 6 months assessing for alcohol use	after 6 months