NCT06318078

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,140

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 19, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 23, 2024

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Out Patient Department attendance (due to malaria, pneumonia and diarrhoea)

    Attendance measured through baseline and endline surveys

    Over 1 year

  • Hospitalisation (due to malaria, pneumonia and diarrhoea)

    Attendance measured through baseline and endline surveys

    Over 1 year

  • malaria related mortality in the community and health facilities

    Malaria related mortality measured through routine data

    Over 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

570 children will be allocated to the intervention arm and children in this arm will be assessed using the eCHIS digital tool.

Other: eCHIS

Control

NO INTERVENTION

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.

Interventions

eCHISOTHER

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).

Intervention

Eligibility Criteria

Age3 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • · 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buikwe

Buikwe, Uganda

RECRUITING

MeSH Terms

Conditions

MalariaDiarrheaPneumonia

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • John Baptist Bwanika

    Malaria Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster Randomised Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

March 19, 2024

Study Start

December 1, 2023

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

March 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations