Evaluating Alcohol Use in Alcoholic Liver Disease

NCT ID: NCT03267069

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-27
• Study Completion Date: 2027-11-01

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.

Conditions

Alcoholic Liver Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

survey

Intervention Type: OTHER

surveys will be administered at inclusion and follow-ups

Interventions

survey

surveys will be administered at inclusion and follow-ups

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• alcoholic liver disease able to consent

Exclusion Criteria

• without alcoholic liver disease unable to consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicole T Shen

OTHER

Sponsor Role: lead

Responsible Party

Nicole T Shen

Gastroenterology and Hepatology Fellow Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert S Brown, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center

Locations

New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole T Shen, MD

Role: CONTACT

nts9004@nyp.org

3146095911

Robert S Brown, MD, MPH

Role: CONTACT

rsb2005@med.cornell.edu

(646) 962-5483

Facility Contacts

Nicole T Shen, MD

Role: primary

nts9004@nyp.org

314-609-5911

Cecilia M Mero

Role: backup

cmm2002@med.cornell.edu

(646) 962-9358

References

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.

Reference Type: DERIVED

PMID: 37126326 (View on PubMed)

Other Identifiers

1601016922

Identifier Type: -

Identifier Source: org_study_id