Pneumonia ChildhoodNCT07369817
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
A study testing ALRITE in people with Pneumonia Childhood and Childhood Asthma, run by University of Washington at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia Childhood, Childhood Asthma, Acute Lower Respiratory Illness
- What is being tested?
- ALRITE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUganda
- Study dates
- 1 Feb 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- inability to read/write English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Makerere University Lung Institute
Kampala
Rebecca Nantanda, MBChB, PhD, MMed, 0777-723332, rnantanda@gmail.com
About this study
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?
Read more
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
- Pneumonia Childhood, Childhood Asthma, Acute Lower Respiratory Illness, Wheezing Lower Respiratory Illness
- Being tested
- ALRITE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALRITEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ALRITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At enrollment
Healthcare worker retention (study feasibility)
Proportion of healthcare workers active in the study over total number enrolled
Measured: 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
Measured: 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
Measured: 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.
Measured: Monthly from baseline (day 1) through the study completion, estimated 20 months
Secondary outcomes (2)
Diagnosis rate of wheezing illness
Diagnosis rates of wheezing illness/asthma among all young children presenting to study sites, as recorded in the health record
Measured: Monthly from baseline through study completion, estimated 20 months
Diagnosis rate of pneumonia
Diagnosis rates of pneumonia among all young children presenting to study sites, as recorded in the health record
Measured: Monthly from baseline through study completion, estimated 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interrupted time series design, no comparison group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Laura Ellington, University of Washington
- Investigators
- Laura Ellington, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369817
- Sponsor's protocol ID
- STUDY00020447
- Other IDs
- 5K23HL163321-02
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07369817
- Acronym / sponsor ID
- STUDY00020447
- Conditions
- Pneumonia Childhood, Childhood Asthma, Acute Lower Respiratory Illness, Wheezing Lower Respiratory Illness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interrupted time series design, no comparison group
| Arm | Type | Receives |
|---|---|---|
| ALRITE deployment | Experimental | Other: ALRITEHealthcare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- inability to read/write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALRITEALRITE 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. | Other | ALRITE deployment |
Primary outcome
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)
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
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
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
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.
2 secondary outcomes
Diagnosis rate of wheezing illness
Time frame: Monthly from baseline through study completion, estimated 20 months
Diagnosis rate of pneumonia
Time frame: Monthly from baseline through study completion, estimated 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Ellington, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALRITE in people with Pneumonia Childhood and Childhood Asthma, run by University of Washington at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Edelson (206-779-9351, jedelson@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare worker enrollment (study feasibility) (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.