Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318078
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-01-23
Brief Title:
Buikwe Electronic Community Health Information System Impact Study
Sponsor:
Malaria Consortium
Organization:
Malaria Consortium
Study Overview
Official Title:
A Research Study to Understand the Impact and Cost-effectiveness of a Digital Health Platform for iCCM in Uganda
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes
Detailed Description:
Following national guidelines 2 VHTs per village will be supported to provide the full eCHIS community health package In total 856 VHTs in Buikwe district will have been trained and equipped with the national strategy and operational guidelines on eCHIS as well as the VHT full package iCCM and VHT basic package reproductive health immunization nutrition guidelines The VHTs will be equipped with mobile devices and iCCM supplies to start the management of community-based health among children aged five years within their respective communities A cross-sectional cluster randomized controlled trial cRCT will be used to establish study outcomes in children under 5 years in the intervention and control areas using mixed methods qualitative and quantitative of data collection
A total sample size of 1140 children under five 570 children under five per arm was scientifically determined for the study During data collection several quality control measures will be applied to ensure the data recorded reflect the facts responses observations and events A standard operating procedure SOP with roles and responsibilities of the data collectors will be prepared to ensure standardized methods for capturing data After endline data collection difference-in-differences DID analysis will be done to derive an estimate of the intervention effect on odds of the study outcomes
Results will be disseminated through agreed peer-review publications and international conferences Malaria Consortium Uganda will work with relevant stakeholders at the Ministry of Health and Medic Mobile to disseminate findings nationally and throughout the study district
A total sample size of 1140 children under five 570 children under five per arm was scientifically determined for the study During data collection several quality control measures will be applied to ensure the data recorded reflect the facts responses observations and events A standard operating procedure SOP with roles and responsibilities of the data collectors will be prepared to ensure standardized methods for capturing data After endline data collection difference-in-differences DID analysis will be done to derive an estimate of the intervention effect on odds of the study outcomes
Results will be disseminated through agreed peer-review publications and international conferences Malaria Consortium Uganda will work with relevant stakeholders at the Ministry of Health and Medic Mobile to disseminate findings nationally and throughout the study district
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None