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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: PACTR
Last refreshed on: 29 May 2023
Main ID:  PACTR201110000319392
Date of registration: 03/10/2011
Prospective Registration: No
Primary sponsor: VLIR
Public title: Screening and brief intervention of alcohol problems in hospital out-patients [retrospectively registered]
Scientific title: 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: 01/02/2011
Target sample size: 280
Recruitment status: Complete
URL:  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=319
Study type:  Interventional
Study design:  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  
Phase:  Not Applicable
Countries of recruitment
South Africa
Contacts
Name: Supa     Pengpid
Address:  Garankua 0204 Pretoria South Africa
Telephone: 012 521 5036
Email: Supa_Pengpid@embanet.com
Affiliation:  Professor/University of Limpopo
Name: Supa    Pengpid
Address:  Garankua 0204 Pretoria South Africa
Telephone: 012 521 5036
Email: Supa_Pengpid@embanet.com
Affiliation:  Professor/University of Limpopo
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied

Nutritional, Metabolic, Endocrine
alcohol misuse
Nutritional, Metabolic, Endocrine
alcohol misuse
Intervention(s)
Alcohol health education leaflet
Brief alcohol counselling
Primary Outcome(s)
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
Secondary Outcome(s)
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.
Secondary ID(s)
Source(s) of Monetary Support
VLIR
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 10/11/2010
Contact:
Medunsa Research & Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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