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

NCT07369817 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY000204475K23HL163321-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Lower Respiratory Illness; Wheezing Lower Respiratory Illness; Pneumonia Childhood; Childhood Asthma

Outcome Measures

Primary Outcomes (5)

• Healthcare worker enrollment (study feasibility)

  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)

  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)

  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)

  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)

  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 Outcomes (2)

• Diagnosis rate of wheezing illness

  Monthly from baseline through study completion, estimated 20 months

• Diagnosis rate of pneumonia

  Monthly from baseline through study completion, estimated 20 months

Study Arms (1)

ALRITE deployment

EXPERIMENTAL

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.

Other: ALRITE

Interventions

ALRITE OTHER

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.

ALRITE deployment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• inability to read/write English

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Makerere University Lung Institute

Kampala, Uganda

Location

Study Officials

• Laura Ellington, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Edelson

CONTACT

206-779-9351; jedelson@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics

Model Details: Interrupted time series design, no comparison group

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)