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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.: PACTR201301000469382 Date registered: 2012/12/06
TRIAL DESCRIPTION
Public title HOME SAFETY PROGRAMME, ITS EFFECT ON MOTHERS┬┐ KNOWLEDGE AND BEHAVIOR AND UNDER-FIVE HOME ACCIDENTS RATE IN KHARTOUM STATE
Official scientific title CLUSTER-RANDOMIZED TRIAL OF HOME SAFETY: ITS EFFECT ON MOTHERS┬┐ KNOWLEDGE AND BEHAVIOR AND UNDER-FIVE HOME ACCIDENTS RATE IN KHARTOUM STATE
Brief summary describing the background
and objectives of the trial
Background: Children are naturally curious, that makes them at high risk for accidents and hazards. Home accidents rate in developing countries is still high and neglected (Peden, 2008). Developing a module for prevention and immediate intervention by innovative participatory health education would be effective, acceptable, and applicable. Objective: The objective of this study is to assess the effect of Innovative Participatory Health Education (IPHE) of home safety on under-five home accidents
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 Education/Counselling/Training
Anticipated trial start date 2011-12-12
Actual trial start date 2012-01-15
Anticipated date of last follow up 2012-09-12
Actual date of last follow up 2012-09-10
Anticipated target sample size (number of participants) 300   
Actual target sample size (number of participants) 236   
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 Cluster randomization Numbers Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Innovative Participatory Heath Education in Home Safety monthly 4 months Innovative Participatory Heath Education in Home Safety 126
Control group Control group no dose 4 months as usual 110 Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Mothers have under-five child Handicapped 19 Years 46 Years Female

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 2011/12/25 UMST Ethical Committee
Ethics Committee Address
Street address City Postal code Country
http://umst-edu.com/SUMASRI.aspx Khartoum 00249 Sudan

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mothers' knowledge four months
Primary Outcome Mothers' behaviour Mothers' behaviour
Secondary Outcome Under-five home accidents rate Mothers' knowledge

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Academy Charity Teaching Hospital Sudan-Khartoum-Alemtidad Khartoum 00249 Sudan

FUNDING SOURCES
Name of source Street address City Postal code Country
No funding

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Waled Amen Mohammed Sudan-Khartoum-Tooty Island - Alguzur-House number 23 Khartoum 00249 Sudan Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Khalifa Elmusharaf Sudan-Khartoum-Ebied Khetim- House number: Khartoum 00249 Sudan

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Waled Ahmed weliameen1980@yahoo.com 0122989400
Street address City Postal code Country Position / Affiliation
Khartoum - Tooty Island-House number 23 Khartoum 00249 Sudan Dr
Role Name Email Phone Fax
Public Enquiries Prof Awatif Osman nurscolumst@hotmail.com 0122189840
Street address City Postal code Country Position / Affiliation
Khartoum-Alamarat - Khartoum Airport Street Khartoum 00249 Sudan Prof
Role Name Email Phone Fax
Scientific Enquiries Dr Khalifa Elmusharaf khalifa_elmusharaf@ yahoo.com 36772110
Street address City Postal code Country Position / Affiliation
Bahrain-Manama Manama 00973 Bahrain Dr