Clinical trial NCT06318078: Buikwe Electronic Community Health Information System Impact Study
Official title: A Research Study to Understand the Impact and Cost-effectiveness of a Digital Health Platform for iCCM in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malaria
Diarrhea
Pneumonia
Lead sponsor: Malaria Consortium
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 1140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomised Control Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)
timeFrame: Over 1 year
measure: Hospitalisation (due to malaria, pneumonia and diarrhoea)
timeFrame: Over 1 year
measure: malaria related mortality in the community and health facilities
timeFrame: Over 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Buikwe
country: Uganda
facility: Buikwe
Study officials:
affiliation: Malaria Consortium
name: John Baptist Bwanika
role: PRINCIPAL_INVESTIGATOR
References: