The EPICS Trial: Enabling Parents to Increase Child Survival
| ISRCTN | ISRCTN52433336 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52433336 |
| Secondary identifying numbers | 1000 |
- 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
Scientific
London School of Economics
Centre for Economic Performance
London
W2 1SP
United Kingdom
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2007 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 11,400 children and their mothers |
| 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
- England
- Guinea-Bissau
- United Kingdom
Study participating centre
London School of Economics
London
W2 1SP
United Kingdom
W2 1SP
United Kingdom
Sponsor information
Effective Intervention (UK)
Charity
Charity
c/o Dr Peter Boone
London School of Economics
Centre for Economic Performance
Houghton Street
London
W2 1SP
United Kingdom
| Website | http://www.effint.org/ |
|---|---|
"ROR" |
https://ror.org/00a1wp308 |
Funders
Funder type
Charity
Effective Intervention (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/08/2009 | Yes | No | |
| Results article | results | 02/09/2011 | Yes | No | |
| Results article | results | 01/05/2016 | Yes | No |
Editorial Notes
04/05/2016: Publication reference added.
