Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1000
Study information
Scientific title
The EPICS Trial: Enabling Parents to Increase Child Survival - a cluster randomised controlled trial
Acronym
EPICS
Study hypothesis
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.
Ethics approval
1. Ministry of Health, Bissau, Guinea-Bissau, 13/06/2007, ref: 021/2007
2. London School of Hygiene and Tropical Medicine, UK, 03/10/2007, ref: 5173
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Child mortality
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The proportion of children that die during the study period. Outcomes assessed until 1st October 2010.
Secondary outcome measures
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 01/10/2010.
Overall trial start date
01/09/2007
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
146 clusters were chosen in Quinara and Tombali.
Inclusion criteria for mothers:
Women enumerated during a baseline survey aged between 12 and 49 years
Inclusion criteria for children:
1. Both males and females, five years of age or younger
2. Children born after randomisation, or born after the baseline survey
3. Alive at the time of randomisation
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
11,400 children and their mothers
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/09/2007
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Guinea-Bissau
Trial participating centre
London School of Economics
London
W2 1SP
United Kingdom
Sponsor information
Organisation
Effective Intervention (UK)
Sponsor details
c/o Dr Peter Boone
London School of Economics
Centre for Economic Performance
Houghton Street
London
W2 1SP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Effective Intervention (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19650919
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21888632
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27102196
Publication citations
-
Protocol
Mann V, Fazzio I, King R, Walker P, dos Santos A, de Sa JC, Jayanti C, Frost C, Elbourne D, Boone P, The EPICS Trial: Enabling Parents to Increase Child Survival through the introduction of community-based health interventions in rural Guinea Bissau., BMC Public Health, 2009, 9, 279, doi: 10.1186/1471-2458-9-279.
-
Results
Fazzio I, Mann V, Boone P, Temporal trends (1977-2007) and ethnic inequity in child mortality in rural villages of southern Guinea Bissau., BMC Public Health, 2011, 11, 683, doi: 10.1186/1471-2458-11-683.
-
Results
Boone P, Elbourne D, Fazzio I, Fernandes S, Frost C, Jayanty C, King R, Mann V, Piaggio G, Dos Santos A, Walker PR, Effects of community health interventions on under-5 mortality in rural Guinea-Bissau (EPICS): a cluster-randomised controlled trial, Lancet Glob Health, 2016, 4, 5, e328-e335, doi: 10.1016/S2214-109X(16)30048-1.