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: pactr.samrc.ac.za
Trial no.: PACTR201110000319392 Date of Registration: 03/10/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 alcohol misuse,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/02/2011
Actual trial start date 03/02/2011
Anticipated date of last follow up 15/05/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 280
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Outcome Assessors
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 Age Category Minimum age Maximum 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 Year(s) 80 Year(s) 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 10/11/2010 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 Street address
Principal Investigator Supa Pengpid Supa_Pengpid@embanet.com 012 521 5036 Garankua
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Professor/University of Limpopo
Role Name Email Phone Street address
Public Enquiries Supa Pengpid Supa_Pengpid@embanet.com 012 521 5036 Garankua
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa Professor/University of Limpopo
Role Name Email Phone Street address
Scientific Enquiries Supa Pengpid Supa_Pengpid@embanet.com 012 521 5036 Garankua
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa Professor/University of Limpopo
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information