The EPICS Trial: Enabling Parents to Increase Child Survival

ISRCTN	ISRCTN52433336
DOI	https://doi.org/10.1186/ISRCTN52433336
Protocol serial number	1000
Sponsor	Effective Intervention (UK)
Funder	Effective Intervention (UK)

Submission date: 13/05/2009
Registration date: 09/06/2009
Last edited: 04/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Boone
Scientific

London School of Economics
Centre for Economic Performance
London
W2 1SP
United Kingdom

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	The EPICS Trial: Enabling Parents to Increase Child Survival - a cluster randomised controlled trial
Study acronym	EPICS
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The proportion of children that die during the study period. Outcomes assessed until 1st October 2010.
Key secondary outcome measure(s)	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.
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	11400
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/09/2007
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

United Kingdom
England
Guinea-Bissau

Study participating centre

London School of Economics

London
W2 1SP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/09/2011		Yes	No
Results article	results	01/05/2016		Yes	No
Protocol article	protocol	03/08/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/05/2016: Publication reference added.