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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614001271695
Date of registration: 04/12/2014
Prospective Registration: No
Primary sponsor: Dr Carol Reid
Public title: Assessing alcohol use and a brief intervention using the Audit C and the 5As for people with chronic viral Hepatitis B and C: A randomised controlled trial
Scientific title: To assess the effect of a brief motivational interviewing intervention using the 5As Model for people with Hepatitis B and C who drink alcohol on alcohol cessation: A randomised controlled trial.
Date of first enrolment: 01/07/2013
Target sample size: 132
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12614001271695.aspx
Study type:  Interventional
Study design:  Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase: 
Countries of recruitment
Australia
Contacts
Name: Dr Carol Reid   
Address:  School of Nursing, Queensland University of Technology Victoria Park RD Kelvin Grove QLD 4059 Australia
Telephone: +61 7 31389607
Email: c2.reid@qut.edu.au
Affiliation: 
Name: Dr Carol Reid   
Address:  School of Nursing, Queensland University of Technology Victoria Park RD Kelvin Grove QLD 4059 Australia
Telephone: +61 7 31389607
Email: c2.reid@qut.edu.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Participants who drink alcohol, are over 18 years of age, have Hepatitis B and/or C and are not currently on any alcohol management program are eligible to take part in the study.
Exclusion criteria: 1. People who are currently undergoing interferon based treatment will be excluded from the study as symptoms from treatment may confound the health outcomes being measured in the project.
2. People who are assessed as being acutely mentally unwell or cognitvely impaired as the questionnaires have not been tested in this group.
3. People who do not speak or read english (the questionnaires have not been tested in this group)


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Alcohol use in Viral Hepatitis;
Alcohol use in Viral Hepatitis
Mental Health - Addiction
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Intervention(s)
Those in Intervention group will be assessed for alcohol use using the Audit-C and receive the Brief intervention using the 5As model from the nurses practitioner. The 10 minute intervention will be conducted as a part of the routine 30 minute appointment. The BI will comprise of Assessing people for their alcohol use, readiness to quit/reduce and level of alcohol dependence; Advising how they may stop drinking and the provision of evidence based written information; Agreeing on a realistic set of goals with the patient; Assisting with a plan to stop drinking and Arranging follow up with a specialist Alcohol and Drug service.

The questionnaires for the intervention and control groups include Audit C, which assesses people for risky alcohol use
Timeline Followback_Alcohol measures how much alcohol a person drinks over a 30 day period and the World Health Organisation Quality of Life (Brief) questionnaire. Demographics will also be collected.
Primary Outcome(s)
Primary outcome is Reduction in Alcohol use as measured by:
Audit C and Timeline Followback Alcohol survey.
[This will be measured at baseline (on recruitment), 4 weeks and 8 weeks]
Secondary Outcome(s)
Quality of life measured by World Health Organisation Quality of Life-BREF (WHOQOL-BREF)[This will be measured at baseline, 4 weeks and 8 weeks]
Secondary ID(s)
Nil Known
Source(s) of Monetary Support
Royal Brisbane and Women's Hospital Foundation (RBWH) Foundation
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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