Buikwe Electronic Community Health Information System Impact Study

Malaria Clinical Trial

Official title:

A Research Study to Understand the Impact and Cost-effectiveness of a Digital Health Platform for iCCM in Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318078
• Other study ID #: UG2024001
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Malaria Consortium
• Contact: John Baptist Bwanika
• Phone: +256 772744390
• Email: j.bwanika[@]malariaconsortium.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes.

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 1,140 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1140
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 59 Months

Eligibility

Inclusion Criteria:

• · Children between 3-59 months,

• Being resident in the study area,

• Consent to participate in the study obtained,

• Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including attending a designated health centre if their child has malaria symptoms during the data collection period.

Exclusion Criteria:

• Children aged below 3 months and above 59 months

• Children resident outside the study areas

• Those who have not consented to participate in the study

Related Conditions & MeSH terms

• Diarrhea
• Malaria
• Pneumonia

Intervention

Other:
• eCHIS
The electronic Community health Information System (eCHIS) is a Government of Uganda owned application used by community health workers for quality health assessments and improved reporting. The eCHIS intervention allows for the registration of longitudinal profiles for client centered care as well as provides care guidance to aid decision making. For its users, the app has a task tab for schedule management and dashboards for performance help management and impact tracking by supervisors. This app is interoperable with national reporting tools such as DHIS2. The app has ten workflows including registration of households and new persons, death reporting, iCCM assessment, treatment and referral follow up, stock monitoring, data synchronization, pregnancy registration, ANC danger signs and follow up, family planning registration, and screening (tuberculosis, hypertension, sickle cell, tobacco use and net use).

Locations

Country	Name	City	State
Uganda	Buikwe	Buikwe

Sponsors (1)

Lead Sponsor	Collaborator
Malaria Consortium

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)	Attendance measured through baseline and endline surveys	Over 1 year
Primary	Hospitalisation (due to malaria, pneumonia and diarrhoea)	Attendance measured through baseline and endline surveys	Over 1 year
Primary	malaria related mortality in the community and health facilities	Malaria related mortality measured through routine data	Over 1 year