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.: PACTR201206000387125 Date of Approval: 31/05/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hand hygiene
Official scientific title Effect of alcohol-based hand rub use by home-based caregivers on child health in a rural informal settlement: a double blinded randomised controlled trial
Brief summary describing the background and objectives of the trial Trial in hand hygiene by using hand rubs to determine the effect it has on the incidence of acute respiratory infections and diarrhoea of children under 5 years.Pre- and-post experimental assessment of hand hygiene knowledge and current practices amongst the home-based caregivers,implementation of hand hygiene promotion in the form of an educational programme with the use of an alcohol-based hand rub.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Acute respiratory infections and diarrhoea
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 21/05/2012
Actual trial start date 21/05/2012
Anticipated date of last follow up 25/07/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants) 140
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
N11/11/319 Health Research Ethics Committee
N11/11/319 Health Research Ethics Committee
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
Parallel: different groups receive different interventions at same time during study Randomised Every second clinic attendee was sampled if they fit the inclusion criteria and included in the study if they agreed to participate Participants were given the same interventions aside from hand rubs - hand rubs were bar coded externally, and the person providing the hand rubs was blind to their difference Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hand hygiene promotion experiment 6 months education, questionnaire and hand rub 70 Active-Treatment of Control Group
Control Group Control group - hand hygiene placebo 6 months education, questionnaire and placebo hand rub 70 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult home-based caregivers (parent and main caregivers aged 18 years and above of children attending Phola Park who are: a) under 5 years of age b) Living in Phola Park c) Planning to continue residing in Phola Park for the duration of the study Adult home-based caregivers of children under 5 years of age who are: a) Being treated for diarrhoea and respiratory infections b) Placed in custody because the biological parent could not care for them 1 Day(s) 5 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 Health Research Etics Committee
Ethics Committee Address
Street address City Postal code Country
POBox 19063 Tygerberg 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the hand hygiene knowledge and application thereof by the main home-based caregivers of children under 5 years. End of July 2012
Primary Outcome To determine whether the outcome differs between the control and study group. End of July 2012
Primary Outcome To assess whether knowledge and practices of hand hygiene among the home-based caregivers have changed six months after the implementation of the intervention. End of July 2012
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Phola Park Clinic Bukanani street Paarl 7655 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
PNMedical South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PNMedical 5 Van der Bergstreet Strand 7140 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Sr Barties Bukanani street Wellington 7655 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joelynn Geraldine Rachelle Steyn joelynnsteyn@mweb.co.za 0797102735 6 Montmartre street, Klein Parys
City Postal code Country Position/Affiliation
Paarl 7655 South Africa colleagues
Role Name Email Phone Street address
Public Enquiries Cathleen Solomons clsolomon@pgwc.gov.za (o21) 8624520 TC Newman
City Postal code Country Position/Affiliation
Paarl 7655 South Africa Area Manager
Role Name Email Phone Street address
Scientific Enquiries Frederick Marais maraisfck@sun.ac.za (021) 9385053 Tygerberg Hospital
City Postal code Country Position/Affiliation
Tygerberg 7499 South Africa mentor
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