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Evaluating Alcohol Use in Alcoholic Liver Disease

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ClinicalTrials.gov Identifier: NCT03267069
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Nicole T Shen, New York Presbyterian Hospital

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.

Condition or disease Intervention/treatment
Alcoholic Liver Disease 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 [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Evaluating Alcohol Use in Alcoholic Liver Disease
Actual Study Start Date : November 27, 2016
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : November 1, 2027

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. alcohol recidivism assessed by questionnaire [ Time Frame: 6 months ]
    Follow-up questionnaires will be administered at 6 months assessing for alcohol use

  2. alcohol recidivism assessed by clinical interview [ Time Frame: 6 months ]
    Follow-up interviews will be conducted at 6 months assessing for alcohol use

  3. alcohol recidivism assessed by urine ethyl glucuronide [ Time Frame: 6 months ]
    Follow-up urine testing may be conducted at 6 months assessing for alcohol use

  4. alcohol recidivism assessed by blood [ Time Frame: 6 months ]
    Follow-up blood testing may be conducted at 6 months assessing for alcohol use


Secondary Outcome Measures :
  1. alcohol recidivism assessed by questionnaire [ Time Frame: after 6 months ]
    Follow-up questionnaires will be administered after 6 months assessing for alcohol use

  2. alcohol recidivism assessed by clinical interview [ Time Frame: after 6 months ]
    Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use

  3. alcohol recidivism assessed by urine ethyl glucuronide [ Time Frame: after 6 months ]
    Follow-up urine testing may be conducted after 6 months assessing for alcohol use

  4. alcohol recidivism assessed by blood [ Time Frame: after 6 months ]
    Follow-up blood testing may be conducted after 6 months assessing for alcohol use



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects with alcoholic liver disease
Criteria

Inclusion Criteria:

  • alcoholic liver disease able to consent

Exclusion Criteria:

  • without alcoholic liver disease unable to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267069


Contacts
Contact: Nicole T Shen, MD 3146095911 nts9004@nyp.org
Contact: Robert S Brown, MD, MPH (646) 962-5483 rsb2005@med.cornell.edu

Locations
United States, New York
New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center Recruiting
New York, New York, United States, 10021
Contact: Nicole T Shen, MD    314-609-5911    nts9004@nyp.org   
Contact: Cecilia M Mero    (646) 962-9358    cmm2002@med.cornell.edu   
Sponsors and Collaborators
Nicole T Shen
Investigators
Principal Investigator: Robert S Brown, MD, MPH New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center

Responsible Party: Nicole T Shen, Gastroenterology and Hepatology Fellow Physician, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT03267069     History of Changes
Other Study ID Numbers: 1601016922
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs