Optimization and Testing of ALRITE, a Clinical Decision Support Tool for Management of Respiratory Illnesses in Young Children in Primary Care Health Facilities in Uganda

January 23, 2026 updated by: Laura Ellington, University of Washington

The goal of this study is to pilot test the feasibility of a mobile health clinical decision support tool called ALRITE for the diagnosis and management of acute lower respiratory illnesses in young children in Uganda. Asthma/wheezing illness, in particular, is underdiagnosed in this setting. The main questions the study aims to answer are:

  • Are the intervention structure, processes, outcomes, and implementations strategies feasible to conduct in the desired settings?
  • Does ALRITE increase the diagnosis of wheezing illness among children seen at Ugandan health centers?

Researchers will compare outcomes before and after ALRITE deployment to healthcare workers at 4 Ugandan healthcare centers using an interrupted time series design. Study participants are healthcare workers.

There will be12 months of baseline data collection ("baseline period"), at the beginning of which healthcare workers will be enrolled at each site. Following the baseline period, health workers will receive ALRITE training and will be encouraged but not required to use ALRITE in clinical care for a 6-month intervention period. Health worker participants will fill out surveys and participate in focus group discussions to provide feedback.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

48

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 Locations

      • Kampala, Uganda
        • Makerere University Lung Institute
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthcare workers employed at each study site with a minimum of 6 months' experience of caring for children with respiratory symptoms in general outpatient care
  • Completed one of the following training programs: medical officer, clinical officer, nurse, midwife
  • proficient in reading and speaking English, one of the official languages of Uganda
  • at least 18 years of age

Exclusion Criteria:

  • inability to read/write English

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALRITE deployment
Healthcare workers will undergo training in the mobile health decision support tool called ALRITE. They will each receive an ALRITE-enabled tablet to use in clinical care. ALRITE use is encouraged but not required. Researchers will collect clinical data from the health record at each study site to evaluate the effect of the ALRITE intervention on acute lower respiratory illness diagnosis and treatment.
ALRITE is a point-of-care mobile health clinical decision support tool designed for use by healthcare workers in Uganda. ALRITE guides the user into entering patient information and provides guideline-concordant recommendations. ALRITE also includes educational videos and weight-based dosing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare worker enrollment (study feasibility)
Time Frame: At enrollment
Number of healthcare workers enrolled during the baseline phase and additional healthcare workers who were enrolled during the remaining study period (ex: new hires or transfers)
At enrollment
Healthcare worker retention (study feasibility)
Time Frame: From enrollment through study completion, an average of 20 months
Proportion of healthcare workers active in the study over total number enrolled
From enrollment through study completion, an average of 20 months
Availability of ALRITE-enabled devices (study feasibility)
Time Frame: Monthly during the intervention period from ALRITE deployment through study completion, an average of 6 months
Proportion of functional devices over number of devices provided to the facility per month
Monthly during the intervention period from ALRITE deployment through study completion, an average of 6 months
ALRITE training completion (study feasibility)
Time Frame: During ALRITE deployment at the end of the baseline period, estimated 1-2 months
Number of ALRITE training sessions completed per site
During ALRITE deployment at the end of the baseline period, estimated 1-2 months
Data completeness (study feasibility)
Time Frame: Monthly from baseline (day 1) through the study completion, estimated 20 months
Percentage of eligible pediatric cases correctly abstracted from the health facility records into the electronic database.
Monthly from baseline (day 1) through the study completion, estimated 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis rate of wheezing illness
Time Frame: Monthly from baseline through study completion, estimated 20 months
Diagnosis rates of wheezing illness/asthma among all young children presenting to study sites, as recorded in the health record
Monthly from baseline through study completion, estimated 20 months
Diagnosis rate of pneumonia
Time Frame: Monthly from baseline through study completion, estimated 20 months
Diagnosis rates of pneumonia among all young children presenting to study sites, as recorded in the health record
Monthly from baseline through study completion, estimated 20 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Laura Ellington, MD, MS, University of Washington

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 (Estimated)

February 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00020447
  • 5K23HL163321-02 (U.S. NIH Grant/Contract)

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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