- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369817
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
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jane Edelson
- Phone Number: 206-779-9351
- Email: jedelson@uw.edu
Study Locations
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-
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Kampala, Uganda
- Makerere University Lung Institute
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Contact:
- Rebecca Nantanda, MBChB, PhD, MMed
- Phone Number: 0777-723332
- Email: rnantanda@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare worker enrollment (study feasibility)
Time Frame: At enrollment
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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)
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At enrollment
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Healthcare worker retention (study feasibility)
Time Frame: From enrollment through study completion, an average of 20 months
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Proportion of healthcare workers active in the study over total number enrolled
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From enrollment through study completion, an average of 20 months
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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
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Proportion of functional devices over number of devices provided to the facility per month
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Monthly during the intervention period from ALRITE deployment through study completion, an average of 6 months
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ALRITE training completion (study feasibility)
Time Frame: During ALRITE deployment at the end of the baseline period, estimated 1-2 months
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Number of ALRITE training sessions completed per site
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During ALRITE deployment at the end of the baseline period, estimated 1-2 months
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Data completeness (study feasibility)
Time Frame: Monthly from baseline (day 1) through the study completion, estimated 20 months
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Percentage of eligible pediatric cases correctly abstracted from the health facility records into the electronic database.
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Monthly from baseline (day 1) through the study completion, estimated 20 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnosis rate of wheezing illness
Time Frame: Monthly from baseline through study completion, estimated 20 months
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Diagnosis rates of wheezing illness/asthma among all young children presenting to study sites, as recorded in the health record
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Monthly from baseline through study completion, estimated 20 months
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Diagnosis rate of pneumonia
Time Frame: Monthly from baseline through study completion, estimated 20 months
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Diagnosis rates of pneumonia among all young children presenting to study sites, as recorded in the health record
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Monthly from baseline through study completion, estimated 20 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura Ellington, MD, MS, University of Washington
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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