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ISRCTN
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ISRCTN52433336
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DOI
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10.1186/ISRCTN52433336
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The EPICS Trial: Enabling Parents to Increase Child Survival
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Scientific title
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The EPICS Trial: Enabling Parents to Increase Child Survival - a cluster randomised controlled trial
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Acronym
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EPICS
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Serial number at source
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1000
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Study hypothesis
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The aim of the trial is to assess whether an intervention package that includes community health promotion campaign and education through health clubs, intensive training and mentoring of village health workers to diagnose and provide first-line treatment for children's diseases within the community, and improved outreach services can generate a rapid and cost-effective reduction in under-five child mortality in rural regions of Guinea-Bissau.
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Lay summary
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Not provided at time of registration
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Ethics approval
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1. Ministry of Health, Bissau, Guinea-Bissau, approved on the 13th June 2007 (ref: 021/2007)
2. London School of Hygiene and Tropical Medicine, UK, approved on the 3rd October 2007 (ref: 5173)
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Study design
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Cluster randomised controlled trial
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Countries of recruitment
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Guinea-Bissau
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Disease/condition/study domain
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Child mortality
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Participants - inclusion criteria
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146 clusters were chosen in Quinara and Tombali.
1. Inclusion criteria for mothers:
Women enumerated during a baseline survey aged between 12 and 49 years
2. Inclusion criteria for children:
2.1. Both males and females, five years of age or younger
2.2. Children born after randomisation, or born after the baseline survey
2.3. Alive at the time of randomisation
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/09/2007
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Anticipated end date
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01/10/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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11,400 children and their mothers
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Interventions
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This is a cluster randomised controlled trial involving 146 clusters. The trial will run for 2.5 years.
Intervention group: community health clubs, trained village health workers, community provision of medicines, and mobile clinics
Control group: standard care
Intervention personnel will assist anyone in Emergencies. Controls will benefit from the training of health staff at clinics.
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Primary outcome measure(s)
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The proportion of children that die during the study period. Outcomes assessed until 1st October 2010.
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Secondary outcome measure(s)
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1. Neonatal, infant and maternal mortality rates
2. Age at and cause of child deaths
3. Treatment practices for sick children
4. Mother's or primary carer's health knowledge
5. Deliveries conducted at institutions or with a trained assistant
6. Indicators of safe birthing practices
Outcomes assessed until 1st October 2010.
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Sources of funding
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Effective Intervention (UK)
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Trial website
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Publications
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1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19650919
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21888632
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Contact name
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Dr
Peter
Boone
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Address
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London School of Economics
Centre for Economic Performance
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City/town
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London
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Zip/Postcode
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W2 1SP
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Country
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United Kingdom
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Sponsor
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Effective Intervention (UK)
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Address
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c/o Dr Peter Boone
London School of Economics
Centre for Economic Performance
Houghton Street
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City/town
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London
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Zip/Postcode
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W2 1SP
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Country
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United Kingdom
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Sponsor website:
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http://www.effint.org/
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Date applied
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13/05/2009
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Last edited
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17/01/2012
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Date ISRCTN assigned
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09/06/2009
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