Condition category
Not Applicable
Date applied
13/05/2009
Date assigned
09/06/2009
Last edited
17/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Boone

ORCID ID

Contact details

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

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, 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)

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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 1st October 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.

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

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

http://www.effint.org/

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

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19650919
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21888632

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes