Trial Outcomes & Findings for Developing a Childhood Asthma Risk Passive Digital Marker (NCT NCT05826561)
NCT ID: NCT05826561
Last Updated: 2026-07-21
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
8 to 12 months
Results posted on
2026-07-21
Participant Flow
Practicing pediatricians were recruited from clinics in Indiana over a 6-month recruitment period.
Eligible participants were board-certified or board-eligible pediatricians providing outpatient pediatric care. No restrictions were applied regarding years of experience, practice setting, or demographic characteristics.
Participant milestones
| Measure |
Control Clinicians - Post Test Only
Planned for N=25 control pediatric clinicians to receive the post test only. Actual Number recruited and enrolled: N=4 Each clinician was 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
Planned for N=25 intervention pediatric clinicians to receive the post test only.
Actual Number recruited and enrolled: N=9 Using the Passive Digital Marker (PDM) clinical decision support risk classification, each clinician was 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
Planned for N=25 control pediatric clinicians to receive the pre and post tests.
Actual number recruited and enrolled: N=10 Each clinician was 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
Planned for N=25 intervention pediatric clinicians to receive the pre and post tests.
Actual Number recruited and enrolled: N=11. Using the PDM, each clinician was 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
10
|
11
|
|
Overall Study
COMPLETED
|
4
|
9
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Developing a Childhood Asthma Risk Passive Digital Marker
Baseline characteristics by cohort
| Measure |
Control Clinicians - Post Test Only
n=4 Participants
N=4. Each clinician was 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
n=9 Participants
N=9. Using the PDM, each clinician was 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
n=10 Participants
N=10. Each clinician was 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
n=11 Participants
N=11. Using the PDM, each clinician was 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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
34 Participants
n=568 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
16 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
18 Participants
n=568 Participants
|
|
Race/Ethnicity, Customized
Count of White Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
29 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
34 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: 8 to 12 monthsPopulation: Only clinicians who were assigned to the PDM intervention responded to perceived PDM acceptance measured using a Behavioral Intention scale (BIS).
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).
Outcome measures
| Measure |
Control Clinicians - Post Test Only
Each clinician was 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
n=90 Vignette
Using the PDM, each clinician was 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
Each clinician was 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
n=110 Vignette
Using the PDM, each clinician was 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.
|
|---|---|---|---|---|
|
Perceived PDM Acceptance
|
—
|
3.97 Score on a Likert Scale (0-5)
Standard Deviation 1.30
|
—
|
4.04 Score on a Likert Scale (0-5)
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: 8 to 12 monthsPopulation: Only clinicians who were assigned to the PDM intervention responded to perceived PDM usability measured using a modified Simplified System Usability Scale (SUS)
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).
Outcome measures
| Measure |
Control Clinicians - Post Test Only
Each clinician was 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
n=90 Vignettes
Using the PDM, each clinician was 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
Each clinician was 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
n=110 Vignettes
Using the PDM, each clinician was 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.
|
|---|---|---|---|---|
|
Perceived PDM Usability
|
—
|
4.04 Score on a Likert Scale (0-5)
Standard Deviation 1.51
|
—
|
4.04 Score on a Likert Scale (0-5)
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: 8 to 12 monthsPercent of successful study enrollment of eligible clinicians (\>80%)
Outcome measures
| Measure |
Control Clinicians - Post Test Only
n=4 Participants
Each clinician was 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
n=9 Participants
Using the PDM, each clinician was 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
n=10 Participants
Each clinician was 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
n=11 Participants
Using the PDM, each clinician was 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.
|
|---|---|---|---|---|
|
Study Feasibility
|
4 Participants
|
9 Participants
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control Clinicians - Post Test Only
n=40 Vignettes
Each clinician was 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
n=90 Vignettes
Using the PDM, each clinician was 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
n=100 Vignettes
Each clinician was 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
n=110 Vignettes
Using the PDM, each clinician was 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.
|
|---|---|---|---|---|
|
Prognostic Accuracy
|
0.78 Proportion of correct vignettes
Standard Deviation 0.17
|
0.83 Proportion of correct vignettes
Standard Deviation 0.18
|
0.49 Proportion of correct vignettes
Standard Deviation 0.15
|
0.72 Proportion of correct vignettes
Standard Deviation 0.24
|
Adverse Events
Control Clinicians - Post Test Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PDM Intervention Clinicians - Post Test Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Clinicians - Pre and Post Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PDM Intervention Clinicians - Pre and Post Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place