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Health Behavior Feedback Study for Veterans With Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Alcoholic Beverage Medical Research Foundation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00229580
First received: September 27, 2005
Last updated: November 28, 2007
Last verified: November 2007
History of Changes
  Purpose

The purpose of this study was to explore whether a brief (3 session) intervention would impact health behavior of veterans with hepatitis C. The main focus of the intervention was on reduction of heavy drinking with patients who have liver disease. Other study goals were to increase the likelihood that patients would seek out substance use treatment and/or hepatitis C health care services. The study also tested the use of a liver function test called CDT/GGT in detecting heavy drinking. The main hypothesis was that a 3 session intervention with personalized feedback about health behavior would result in a reduction in alcohol use and increased use of substance use treatment and hepatology health care.


Condition Intervention Phase
Alcoholism
Alcohol Abuse
Hepatitis C
Liver Disease
 Behavioral: 3 session brief intervention with health behavior feedback
Other: treatment as usual
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health Behavior Feedback Study for Veterans With Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Reduction in alcohol consumption [ Time Frame: at 6 and 12-week follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Engagement in substance use treatment and hepatitis C specialty care. Detection of elevated CDT in blood serum compared with self-reported heavy drinking. [ Time Frame: 12 weeks post-study ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: December 2003
Study Completion Date: January 2006
Arms Assigned Interventions
Experimental: 1
Motivational feedback
 Behavioral: 3 session brief intervention with health behavior feedback
Active Comparator: 2
treatment as usual
 Other: treatment as usual

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Positive serology for current infection by hepatitis C viremia by PCR confirmation test;
  2. Current alcohol use (past 30 days) as indicated by self-report (using AUDIT- C questions);

  3. Meets hazardous alcohol use criteria as measured by the Alcohol Use Disorders Identification Test.

    Criteria per (National Institute on Alcohol Abuse and Alcoholism, 1995):

    1. for women, 7 or more drinks per week or 4 or more drinks per occasion;
    2. for men, 14 or more drinks per week or 5 or more drinks per occasion;
  4. Not currently engaged (past 30 days) in VA specialty substance use disorder treatment or mutual help groups like AA/NA.

Exclusion Criteria:

  1. Abstinent from alcohol use in last 30 days as indicated by self-report or less than hazardous use according to criteria listed above by the AUDIT.
  2. Patient is already engaged (past 30 days) in specialty substance use disorder treatment or attends self-help groups.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229580

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
University of Washington
Alcoholic Beverage Medical Research Foundation
Investigators
Principal Investigator: Tania M Davis Correale, PhD Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine
  More Information

No publications provided

Responsible Party: Tania Correale, Ph.D., VA PSHCS/UWashington
ClinicalTrials.gov Identifier: NCT00229580     History of Changes
Other Study ID Numbers: 03-8752-V 03
Study First Received: September 27, 2005
Last Updated: November 28, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Brief Intervention
Motivational Interviewing
Health Psychology
 Alcohol
Hepatitis C
Patient Education

Additional relevant MeSH terms:
Alcoholism
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013