Buikwe Electronic Community Health Information System Impact Study

March 12, 2024 updated by: Malaria Consortium

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

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

Study Overview

Status

Recruiting

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

1140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Buikwe, Uganda
        • Recruiting
        • Buikwe
        • Contact:
          • John Baptist Bwanika, MD
        • Principal Investigator:
          • John Baptist Bwanika, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Over 1 year
Hospitalisation (due to malaria, pneumonia and diarrhoea)
Time Frame: Over 1 year
Attendance measured through baseline and endline surveys
Over 1 year
malaria related mortality in the community and health facilities
Time Frame: Over 1 year
Malaria related mortality measured through routine data
Over 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John Baptist Bwanika, Malaria Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

January 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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