Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12614001271695 |
Date of registration:
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04/12/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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.
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Date of first enrolment:
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01/07/2013 |
Target sample size:
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132 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12614001271695.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Carol Reid
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Address:
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School of Nursing, Queensland University of Technology
Victoria Park RD
Kelvin Grove QLD 4059
Australia |
Telephone:
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+61 7 31389607 |
Email:
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c2.reid@qut.edu.au |
Affiliation:
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Name:
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Dr Carol Reid
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Address:
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School of Nursing, Queensland University of Technology
Victoria Park RD
Kelvin Grove QLD 4059
Australia |
Telephone:
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+61 7 31389607 |
Email:
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c2.reid@qut.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Alcohol use in Viral Hepatitis; Alcohol use in Viral Hepatitis
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Mental Health - Addiction
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Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention(s)
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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.
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Royal Brisbane and Women's Hospital Foundation (RBWH) Foundation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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