- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318078
Buikwe Electronic Community Health Information System Impact Study
A Research Study to Understand the Impact and Cost-effectiveness of a Digital Health Platform for iCCM in Uganda
Study Overview
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 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John Baptist Bwanika
- Phone Number: +256 772744390
- Email: j.bwanika@malariaconsortium.org
Study Contact Backup
- Name: Kevin Baker
- Phone Number: 07811266539044
- Email: k.baker@malariaconsortium.org
Study Locations
-
-
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Buikwe, Uganda
- Recruiting
- Buikwe
-
Contact:
- John Baptist Bwanika, MD
-
Principal Investigator:
- John Baptist Bwanika, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
570 children will be allocated to the intervention arm and children in this arm will be assessed using the eCHIS digital tool.
|
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).
|
No Intervention: Control
570 children will be allocated to the intervention arm and children in this arm will be assessed using the standard care and paper based tools.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)
Time Frame: Over 1 year
|
Attendance measured through baseline and endline surveys
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Over 1 year
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Hospitalisation (due to malaria, pneumonia and diarrhoea)
Time Frame: Over 1 year
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Attendance measured through baseline and endline surveys
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Over 1 year
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malaria related mortality in the community and health facilities
Time Frame: Over 1 year
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Malaria related mortality measured through routine data
|
Over 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Baptist Bwanika, Malaria Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UG2024001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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