Pediatric AsthmaNCT05826561
Developing a Childhood Asthma Risk Passive Digital Marker
A study testing Childhood Asthma Passive Digital Marker in people with Pediatric Asthma, run by Indiana University at 1 site in United States.
Trial summary
Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Asthma
- What is being tested?
- Childhood Asthma Passive Digital Marker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practicing pediatricians within the IU Health Network
Who cannot join
- Non-practicing pediatricians within the IU Health Network
Trial locations and contacts
1 site in 1 country.
About this study
Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used in practice.
The objective of the study is to determine the usability, acceptability, feasibility, and preliminary efficacy of the childhood asthma passive digital marker (PDM) among pediatricians. The study will include practicing pediatricians within the IU Health Network.
- Conditions
- Pediatric Asthma
- Being tested
- Childhood Asthma Passive Digital Marker
- Keywords
- Pediatric Asthma, Early Detection, Screening, Passive Digital Marker, Risk Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childhood Asthma Passive Digital MarkerOther
Also called Passive Screening Test (PDM)
A childhood asthma Passive Digital Marker (PDM) is an ML algorithm that is able to retrieve and synthesize pre-existing "passively" collected mother/child dyad prognostic data in "digital" electronic health record (EHR) to provide an objective and quantifiable "marker" of a child's risk (probability) and associated pathophysiological phenotype to inform clinician decision-making at point-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Control Clinicians - post test only | No intervention | N=25 control pediatric clinicians, who will receive the post test only. Each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. |
| PDM Intervention Clinicians - post test only | Experimental | N=25 intervention pediatric clinicians, who will receive the post test only. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. Receives: Other: Childhood Asthma Passive Digital Marker |
| Control Clinicians - pre and post test | No intervention | N=25 control pediatric clinicians, who will receive the pre and post test. Each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. |
| PDM Intervention Clinicians - pre and post test | Active comparator | N=25 intervention pediatric clinicians, who will receive the pre and post test. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. Receives: Other: Childhood Asthma Passive Digital Marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived PDM Acceptance
Mean Perceived PDM acceptance measured using a Behavioral Intention scale (BIS) with a score Likert scale score of 0-5. Here, higher score values represent a higher acceptability of the PDM (i.e., better outcome).
Measured: 8 to 12 months
Perceived PDM Usability
Mean Perceived Usability measured using a modified Simplified System Usability Scale (SUS) with a score Likert scale of 0-5. Here, higher score values represent a higher perceived usability of the PDM (i.e., better outcome).
Measured: 8 to 12 months
Study Feasibility
Percent of successful study enrollment of eligible clinicians (>80%)
Measured: 8 to 12 months
Secondary outcomes (1)
Prognostic Accuracy
Clinician prognostic accuracy was defined as the proportion of correctly classified vignettes. Accuracy was calculated as: correct vignette classifications ÷ total vignettes evaluated. Values ranged from 0 to 1, with higher values indicating greater prognostic accuracy. Each clinician assessed 10 vignettes (5 cases and 5 controls) and classified them as either high or low risk. A correct classification was high risk for a case and low risk for a control vignette.
Measured: 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jun 2024
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Why it stopped: NIH funding was terminated due to new agency priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Arthur H. Owora, MPH, PhD, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826561
- Sponsor's protocol ID
- 15873
- Other IDs
- K01HL166436
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2023
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Owora AH, Jiang B, Shah Y. Effect of an electronic health record-integrated machine learning asthma risk marker on pediatrician prognostic accuracy during preschool age: a pilot randomized clinical trial. Sci Rep. 2026 Jun 18;16(1):20753. doi: 10.1038/s41598-026-57759-w.
PubMed 42315888
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Childhood Asthma Risk Passive Digital Marker
- ClinicalTrials.gov ID
- NCT05826561
- Acronym / sponsor ID
- 15873
- Conditions
- Pediatric Asthma
- Keywords
- Pediatric Asthma, Early Detection, Screening, Passive Digital Marker, Risk Factors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NIH funding was terminated due to new agency priorities.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Posted 21 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used in practice.
The objective of the study is to determine the usability, acceptability, feasibility, and preliminary efficacy of the childhood asthma passive digital marker (PDM) among pediatricians. The study will include practicing pediatricians within the IU Health Network.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Clinicians - post test only | No intervention | –N=25 control pediatric clinicians, who will receive the post test only. Each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. |
| PDM Intervention Clinicians - post test only | Experimental | Other: Childhood Asthma Passive Digital MarkerN=25 intervention pediatric clinicians, who will receive the post test only. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. |
| Control Clinicians - pre and post test | No intervention | –N=25 control pediatric clinicians, who will receive the pre and post test. Each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. |
| PDM Intervention Clinicians - pre and post test | Active comparator | Other: Childhood Asthma Passive Digital MarkerN=25 intervention pediatric clinicians, who will receive the pre and post test. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children [5 with and 5 without asthma] and asked to provide a prediction of a child's asthma risk at 6-10 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Practicing pediatricians within the IU Health Network
Key exclusion criteria (1 listed)
- Non-practicing pediatricians within the IU Health Network
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 |
|---|---|---|
| Childhood Asthma Passive Digital MarkerAlso: Passive Screening Test (PDM)A childhood asthma Passive Digital Marker (PDM) is an ML algorithm that is able to retrieve and synthesize pre-existing "passively" collected mother/child dyad prognostic data in "digital" electronic health record (EHR) to provide an objective and quantifiable "marker" of a child's risk (probability) and associated pathophysiological phenotype to inform clinician decision-making at point-of-care. | Other | PDM Intervention Clinicians - post test only, PDM Intervention Clinicians - pre and post test |
Primary outcome
Perceived PDM Acceptance
Time frame: 8 to 12 months
Mean Perceived PDM acceptance measured using a Behavioral Intention scale (BIS) with a score Likert scale score of 0-5. Here, higher score values represent a higher acceptability of the PDM (i.e., better outcome).
Perceived PDM Usability
Time frame: 8 to 12 months
Mean Perceived Usability measured using a modified Simplified System Usability Scale (SUS) with a score Likert scale of 0-5. Here, higher score values represent a higher perceived usability of the PDM (i.e., better outcome).
Study Feasibility
Time frame: 8 to 12 months
Percent of successful study enrollment of eligible clinicians (>80%)
1 secondary outcome
Prognostic Accuracy
Time frame: 3 to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42315888Owora AH, Jiang B, Shah Y. Effect of an electronic health record-integrated machine learning asthma risk marker on pediatrician prognostic accuracy during preschool age: a pilot randomized clinical trial. Sci Rep. 2026 Jun 18;16(1):20753. doi: 10.1038/s41598-026-57759-w.
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Asthma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Childhood Asthma Passive Digital Marker in people with Pediatric Asthma, run by Indiana University at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 21 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived PDM Acceptance (time frame: 8 to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05826561, which also lists 1 linked publication.
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 21 Jul 2026.