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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.: PACTR201011000262218 Date registered: 2010/11/12
TRIAL DESCRIPTION
Public title Improving quality of health care for Tanzanian children: Assessing the use of electronic decision
Official scientific title Improving quality of health care for Tanzanian children: Assessing the use of electronic decision support to promote evidence-based medicine and rational use of drugs
Brief summary describing the background
and objectives of the trial
Children die each year before the age of 5 despite effective low-cost interventions. Integrated Management of Childhood Illness (IMCI) algorithms improve quality of care. However, its impact has been less than anticipated due to limited adherence by clinicians. We will test whether new technologies can improve the quality of care for children through electronic decision support to promote evidence-based medicine and new diagnostic tests to promote rational use of drugs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PeDiAtrick
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2010-11-15
Actual trial start date
Anticipated date of last follow up 2012-07-31
Actual date of last follow up
Anticipated target sample size (number of participants) 3090   
Actual target sample size (number of participants)   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
NIMR/HQ/R.8a/Vol.IX/823 Tanzanian National Institute for Medical research
130/09 Ethikkommission beider Basel (EKBB)
130/09 Ethikkommission beider Basel (EKBB)
NIMR/HQ/R.8a/Vol.IX/823 Tanzanian National Institute for Medical research

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 Stratified allocation by health facilities. Allocation by health facilities the patient visited Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Current practice 20 months None 1090
Experimental group Paper algorithm 1 year Training of the clinician with paper algorithm 500
Experimental group Electronic algorithm 1 year Training of the clinician with electronic decision support 1500

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Child brought to health facility involved in the study First visit for this illness episode Consent form signed Follow up visit Main complain trauma or surgical 2 Months 59 Months 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 2009/06/05 NIMR
Ethics Committee Address
Street address City Postal code Country
PO Box 9653 Dar es Salaam PObox 9653 United Republic of Tanzania
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 2009/04/23 Ethikkomission beider Basel
Ethics Committee Address
Street address City Postal code Country
Hebelstrasse 53 Basel 40456 Switzerland

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Health outcome day 7 day 14
Primary Outcome Appropriate diagnoses and treatment Day 0
Primary Outcome Rate of children being prescribed an antibiotic and antimalarial Day 0
Primary Outcome Caretaker understanding Day 0 Day 7

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbagala Kizuiani Temeke district Dar es Salaam United Republic of Tanzania
Mbagala Rangi Tatu Temeke district Dar es Salaam United Republic of Tanzania
Kawe dispensary Kinondoni district Dar es Salaam United Republic of Tanzania
Kigamboni Temeke district Dar es Salaam United Republic of Tanzania
Sinza Health Center Kinondoni district Dar es Salaam United Republic of Tanzania
Mang'ula Kilombero district Mang'ula, Kilombero district United Republic of Tanzania
Signal dispensary Kilombero district Signal, Kilombero district United Republic of Tanzania
Buguruni Health center Ilala district Dar es Salaam United Republic of Tanzania
Vingunguti dispensary Ilala district Dar es Salaam United Republic of Tanzania
Tandale dispensary Kinondoni district Dar es Salaam United Republic of Tanzania
Tabata A dispensary Ilala district Dar es Salaam United Republic of Tanzania

FUNDING SOURCES
Name of source Street address City Postal code Country
Swiss National Science Foundation (SNSF) Wildhainweg 3 P.O. Box 8232 Bern CH-3001 Switzerland
Swiss National Science Foundation (SNSF) Wildhainweg 3 P.O. Box 8232 Bern CH-3001 Switzerland

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Swiss Tropical and Public Health Institute (SwissTPH) Socinstrasse 57 Basel 4002 Switzerland University
Primary Sponsor Swiss Tropical and Public Health Institute (SwissTPH) Socinstrasse 57 Basel 4002 Switzerland University

COLLABORATORS
Name Street address City Postal code Country
Valérie d'Acremont Socinstrasse 57 Basel 4002 Switzerland
Clotilde Rambaud Kinondoni district Dar es Salaam Pobox 78373 United Republic of Tanzania
Salim Abdulla Kiko avenue Dar es Salaam Pobox 78373 United Republic of Tanzania
Amani Shao Kiko avenue Dar es Salaam Pobox 78373 United Republic of Tanzania
Judy Kahama Dar es Salaam Pobox 9084 United Republic of Tanzania
Marc Mitchell 665 Huntington Avenue Building I Room 1209 Boston MA 02115 United States of America
Neal Lesh 529 Main St, Suite 606 Charlestown MA 02129 United States of America
Seneca Perri Dar es Salaam Pobox 78373 United Republic of Tanzania
Valérie d'Acremont Socinstrasse 57 Basel 4002 Switzerland
Clotilde Rambaud Kinondoni district Dar es Salaam Pobox 78373 United Republic of Tanzania
Salim Abdulla Kiko avenue Dar es Salaam Pobox 78373 United Republic of Tanzania
Amani Shao Kiko avenue Dar es Salaam Pobox 78373 United Republic of Tanzania
Judy Kahama Dar es Salaam Pobox 9084 United Republic of Tanzania
Marc Mitchell 665 Huntington Avenue Building I Room 1209 Boston MA 02115 United States of America
Neal Lesh 529 Main St, Suite 606 Charlestown MA 02129 United States of America
Seneca Perri Dar es Salaam Pobox 78373 United Republic of Tanzania

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Blaise Genton Blaise.Genton@unibas.ch +41 79 556 58 68 +41 61 284 81 05
Street address City Postal code Country Position / Affiliation
Socinstrasse 57 Basel 4002 Switzerland Project leader
Role Name Email Phone Fax
Public Enquiries Dr Clotilde Rambaud Clotilde.Rambaud@unibas.ch +255778221305
Street address City Postal code Country Position / Affiliation
Kiko avenue Dar es Salaam PO Box 78373 United Republic of Tanzania Research physician
Role Name Email Phone Fax
Scientific Enquiries Dr Clotilde Rambaud Clotilde.Rambaud@unibas.ch +255778221305
Street address City Postal code Country Position / Affiliation
Kiko avenue Dar es Salaam PO Box 78373 United Republic of Tanzania Research physician