Pan African Clinical Trials Registry South African Medical Research Council, South African Cochrane Centre PO Box 19070, Tygerberg, 7505, South Africa Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836 Email: pactradmin@mrc.ac.za     Website: www.pactr.org Trial no.: PACTR201110000319392 Date registered: 2011/10/03 TRIAL DESCRIPTION Public title Screening and brief intervention of alcohol problems in hospital out-patients [retrospectively registered] Official 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 Brief summary describing the background and objectives of the trial Hospital settings are particularly valuable point of contact for the delivery of brief interventions because of the large access to patient populations each year. The proposed project is a randomized controlled trial aimed at evaluating Screening and Brief Intervention (SBI) for Alcohol problems among hospital out-patients in Gauteng province, South Africa. Objectives: 1. To measure the prevalence of alcohol consumption amongst out-patients at Dr George Mukhari Hospital. 2. To describe drinking patterns of out-patients at Dr George Mukhari Hospital, and identify medium risk drinkers needing intervention. 3. To compare level of alcohol consumption amongst medium risk drinkers between (a) pre intervention,(b)6months,and (c) 12 months after intervention among out-patients at Dr George Mukhari Hospital. 4. To compare alcohol consumption between intervention and control groups at6 and 12 months. Type of trial RCT Acronym (If the trial has an acronym then please provide) Disease(s) or condition(s) being studied Purpose of the trial Treatment Anticipated trial start date 2011-02-01 Actual trial start date 2011-02-03 Anticipated date of last follow up 2012-05-15 Actual date of last follow up Anticipated target sample size (number of participants) 280    Actual target sample size (number of participants)    Recruitment status Completed: recruitment & data analysis complete Secondary Ids Issuing authority/Trial register Links to Secondary ID STUDY DESIGN Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used 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 Masking/blinding used INTERVENTIONS Intervention type Intervention name Dose Duration Intervention description Group size Nature of control Experimental group Brief alcohol counselling 1 20-30 minutes Personalized feedback on their AUDIT results, a health education leaflet, simple advice plus brief counselling about reducing excessive drinking, during a one session 20 minute intervention. 140 Control group Alcohol health education leaflet 1 Provision of health education leaflet on responsible drinking 140 ELIGIBILITY CRITERIA List inclusion criteria List exclusion criteria Min age Max age Gender 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. 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. 18 Years 80 Years Both ETHICS APPROVAL Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee Yes 2010/11/10 Medunsa Research & Ethics Committee Ethics Committee Address Street address City Postal code Country Garankua Pretoria 0204 South Africa OUTCOMES Type of outcome Outcome Timepoint(s) at which outcome measured Primary Outcome 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 6 months 12 months Secondary Outcome 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. 6 months 12 months RECRUITMENT CENTRES Name of recruitment centre Street address City Postal code Country University of Limpopo, Medunsa campus Ga-rankuwa Pretoria 0204 South Africa Dr George Mukhari Hospital Ga-rankuwa Pretoria 0204 South Africa FUNDING SOURCES Name of source Street address City Postal code Country VLIR Universiteitsplein 1 Antwerpen 2610 South Africa SPONSORS Sponsor level Name Street address City Postal code Country Nature of sponsor Primary Sponsor VLIR Universiteitsplein 1 Antwerpen 2610 Belgium Funding Agency COLLABORATORS Name Street address City Postal code Country Supa Pengpid Garankua Pretoria 0204 South Africa Karl Peltzer 134 Pretorius Street Pretoria 0001 South Africa Hendry Heever Garankua Pretoria 0204 South Africa Linda Skaal Garankua Pretoria 0204 South Africa Van Hal Guido Universiteitsplein 1 Antwerpen 2610 Belgium CONTACT PEOPLE Role Name Email Phone Fax Principal Investigator Prof Supa Pengpid Supa_Pengpid@embanet.com 012 521 5036 012 5214175 Street address City Postal code Country Position / Affiliation Garankua Pretoria 0001 South Africa Professor/University of Limpopo Role Name Email Phone Fax Public Enquiries Prof Supa Pengpid Supa_Pengpid@embanet.com 012 521 5036 012 5214175 Street address City Postal code Country Position / Affiliation Garankua Pretoria 0204 South Africa Professor/University of Limpopo Role Name Email Phone Fax Scientific Enquiries Prof Supa Pengpid Supa_Pengpid@embanet.com 012 521 5036 012 5214175 Street address City Postal code Country Position / Affiliation Garankua Pretoria 0204 South Africa Professor/University of Limpopo