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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