Evaluating Alcohol Use in Alcoholic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: survey.
- Who it may be relevant to
- Registry conditions: Alcoholic Liver Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other survey
surveys will be administered at inclusion and follow-ups
Primary outcome measures
- alcohol recidivism assessed by questionnaire [Time frame: 6 months]
- alcohol recidivism assessed by clinical interview [Time frame: 6 months]
- alcohol recidivism assessed by urine ethyl glucuronide [Time frame: 6 months]
- alcohol recidivism assessed by blood [Time frame: 6 months]
Secondary outcome measures (4)
- alcohol recidivism assessed by questionnaire [Time frame: after 6 months]
- alcohol recidivism assessed by clinical interview [Time frame: after 6 months]
- alcohol recidivism assessed by urine ethyl glucuronide [Time frame: after 6 months]
- alcohol recidivism assessed by blood [Time frame: after 6 months]
Eligibility criteria
Inclusion criteria
- alcoholic liver disease able to consent
Exclusion criteria
- without alcoholic liver disease unable to consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Ce — New York
Publications
- Fahoum K, Shen NT, Basu E, Lee J, Kaplan A, Salajegheh A, Rosenblatt R, Jesudian A, Lucero C, Fortune B, Safford M, Brown RS Jr. Prognostic Factors in Alcohol-associated Liver Disease Patients Presenting With First Evidence of Ascites. J Clin Gastroenterol. 2024 Feb 1;58(2):200-206. doi: 10.1097/MCG.0000000000001836. PMID 37126326
Identifiers
NCT: NCT03267069 · 1601016922