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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PACTR |
Last refreshed on:
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29 May 2023 |
Main ID: |
PACTR201110000319392 |
Date of registration:
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03/10/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Screening and brief intervention of alcohol problems in hospital out-patients [retrospectively registered]
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Scientific title:
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Screening and Brief Intervention for Alcohol problems in Dr George Mukhari Hospital out-patients in Gauteng, South Africa: a single-blinded randomized controlled trial |
Date of first enrolment:
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01/02/2011 |
Target sample size:
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280 |
Recruitment status: |
Complete |
URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=319 |
Study type:
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Interventional |
Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,¿Simple randomisation using a radomisation table created by a computer software program,¿Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Supa
Pengpid |
Address:
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Garankua
0204
Pretoria
South Africa |
Telephone:
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012 521 5036 |
Email:
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Supa_Pengpid@embanet.com |
Affiliation:
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Professor/University of Limpopo |
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Name:
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Supa
Pengpid |
Address:
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Garankua
0204
Pretoria
South Africa |
Telephone:
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012 521 5036 |
Email:
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Supa_Pengpid@embanet.com |
Affiliation:
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Professor/University of Limpopo |
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Key inclusion & exclusion criteria
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Inclusion criteria: Out-patients (males and females) 18 years and above, without mental impairment, who visit the hospital out-patient department and who are scored as medium risk drinkers (i.e. 8-19 for men and 7-19 for women on the AUDIT questionnaire) will be included in this study.
Exclusion criteria: Out-patients with a score of 20 and above on the AUDIT (with probable alcohol dependence) will be referred for further management. Also, out-patients who score less than 8 for men and less than 7 for women on the AUDIT questionnaire, patients with mental impairment, those who are pregnant,and those who are already under alcohol treatment, will all be excluded.
Age minimum:
18 Year(s)
Age maximum:
80 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nutritional, Metabolic, Endocrine alcohol misuse
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Nutritional, Metabolic, Endocrine
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alcohol misuse
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Intervention(s)
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Alcohol health education leaflet
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Brief alcohol counselling
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Primary Outcome(s)
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The primary outcome measure used in this study is the change in drinks per week from baseline to follow-up, as estimated from the first two AUDIT questions
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Secondary Outcome(s)
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A secondary measure is the frequency of consuming four or more drinks per occasion (AUDIT question 3). The percentage of patients whose weekly consumption decreases, increases, or remains the same, as well as changes in a combination of the first three AUDIT item scores called the Drinkers¿ index, will also be evaluated in order to estimate the amount of alcohol risk reduction.
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Source(s) of Monetary Support
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VLIR
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Ethics review
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Status: Approved
Approval date: 10/11/2010
Contact:
Medunsa Research & Ethics Committee
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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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