Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001271695
Ethics application status
Approved
Date submitted
10/03/2014
Date registered
4/12/2014
Date last updated
4/12/2014
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 285688 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
BACHI study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use in Viral Hepatitis 290623 0
Condition category
Condition code
Oral and Gastrointestinal 291015 291015 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 293937 293937 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288371 0
Behaviour
Comparator / control treatment
The control group will receive routine care i.e., they may be asked if they drink alcohol and are advised to stop; receive no formalised alcohol assessment or intervention and be seen by clinicians in the clinic as usual .

The outcome measures for the intervention and control groups include Audit C, which measures 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.
Control group
Active

Outcomes
Primary outcome [1] 291000 0
Primary outcome is Reduction in Alcohol use as measured by:
Audit C and Timeline Followback Alcohol survey.
Timepoint [1] 291000 0
This will be measured at baseline (on recruitment), 4 weeks and 8 weeks
Secondary outcome [1] 305792 0
Quality of life measured by World Health Organisation Quality of Life-BREF (WHOQOL-BREF)
Timepoint [1] 305792 0
This will be measured at baseline, 4 weeks and 8 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent the participants will be randomly allocated to either the intervention or control groups by the Nurse practitioner contacting the researcher via phone. The participants, are blinded to the intervention as they do not know what the nurse practitioner has been trained in. The Nurse Practitioner and participants are blinded to the randomisation process. The data collectors and those inputting data are blinded to the randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis: Spss will be used to analyse the data.
Categorical data will be expressed as frequencies and percentages. Fisher’s exact test and logistic regression will be used to compare differences between groups. Continuous data will be expressed as the difference between 8 weeks and baseline, and will be described by means and standard deviations. ANOVA and t-tests will be used to analyse the relationships between two or more groups.
Sample Size: The main outcome variable is change in reported alcohol consumption in a 30 day period and will be measured using the Alcohol Timeline Followback survey. A 50% reduction of alcohol intake over a 30 day period would be seen as a clinically meaningful reduction. It is expected giving participants the Alcohol Timeline Followback Survey will measure a result of 5% of the control group having clinically meaningful alcohol reduction. Sample size calculations were made with a power and sample size program (PS) using a Fishers’s exact test, assuming that 5% of the control group and 25% of the intervention group will show a clinical alcohol reduction. The sample size required to detect this difference using a two sided significance level of 0.05 and 80% power is 118. Allowing for a 10% drop out rate, the required sample size for this study will be approximately 132 people (66 in the control group, and 66 in the intervention group), Assessment and and Brief Intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/06/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
28/02/2014
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2180 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 9004 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 288856 0
Charities/Societies/Foundations
Name [1] 288856 0
Royal Brisbane and Women's Hospital Foundation (RBWH) Foundation
Country [1] 288856 0
Australia
Primary sponsor type
Individual
Name
Dr Carol Reid
Address
School of Nursing, Queensland University of Technology
Victoria Park Rd
Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 287550 0
None
Name [1] 287550 0
Address [1] 287550 0
Country [1] 287550 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Alcohol consumption is a foremost determinant for the prognosis of people with chronic viral hepatitis. There are vital benefits in providing assessment and brief intervention for reducing alcohol consumption and associated harms in people attending primary care settings. This randomised controlled trial aims to identify the effectiveness of an evidence based assessment and brief intervention in reducing or stopping harmful alcohol consumption in people with chronic viral hepatitis. Participants will be randomly allocated to three groups: Group1. (assessment and brochure), Group2. (assessment and brief intervention) or Group3. (routine care with no formalised intervention).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44650 0
Dr Carol Reid
Address 44650 0
School of Nursing, Queensland University of Technology
Victoria Park RD
Kelvin Grove QLD 4059
Country 44650 0
Australia
Phone 44650 0
+61 7 31389607
Fax 44650 0
Email 44650 0
[email protected]
Contact person for public queries
Name 44651 0
Carol Reid
Address 44651 0
School of Nursing, Queensland University of Technology
Victoria Park RD
Kelvin Grove QLD 4059
Country 44651 0
Australia
Phone 44651 0
+61 7 31389607
Fax 44651 0
Email 44651 0
[email protected]
Contact person for scientific queries
Name 44652 0
Carol Reid
Address 44652 0
School of Nursing, Queensland University of Technology
Victoria Park RD
Kelvin Grove QLD 4059
Country 44652 0
Australia
Phone 44652 0
+61 7 31389607
Fax 44652 0
Email 44652 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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