Digital Marker for Asthma

Overseen By Arthur H Owora, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Non-practicing pediatricians

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Childhood Asthma Passive Digital Marker, Childhood Asthma Risk Passive Digital Marker, PDM?

Digital technologies, including digital biomarkers, are being explored to monitor and improve treatment adherence in children with asthma. These technologies can help track physical activity, heart rate, and lung function, which are important for managing asthma effectively. ^{1 2 3 4 5}

How is the Digital Marker for Asthma treatment different from other asthma treatments?

The Digital Marker for Asthma treatment is unique because it focuses on using non-invasive biomarkers to diagnose and monitor asthma, especially in children. This approach aims to provide a more personalized treatment plan by identifying specific asthma types and predicting treatment responses, which is different from traditional methods that rely mainly on clinical symptoms and lung function tests. ^{4 5 6 7 8}

Eligibility Criteria

This trial is for practicing pediatricians within the IU Health Network. It aims to address underdiagnosis and undertreatment in childhood asthma by testing a new tool called a passive digital marker (PDM).

Inclusion Criteria

Practicing pediatricians within the IU Health Network

Exclusion Criteria

Non-practicing pediatricians within the IU Health Network

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Pediatric clinicians use the PDM to predict asthma risk in children based on vignettes

8 to 12 months

Follow-up

Participants are monitored for usability, feasibility, and acceptance of the PDM

4 weeks

Treatment Details

Interventions

• Childhood Asthma Passive Digital Marker

Trial Overview The study is evaluating the usability, acceptability, feasibility, and preliminary efficacy of a Childhood Asthma Passive Digital Marker among pediatricians.

Participant Groups

Group I: PDM Intervention Clinicians - post test only Experimental Treatment 1 Intervention

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.

Group II: Control Clinicians - pre and post test Active Control 1 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.

Group III: PDM Intervention Clinicians - pre and post test Active Control 1 Intervention

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.

Group IV: Control Clinicians - post test only Active Control 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Monitoring childhood asthma should prioritize patient-centered outcomes like exacerbations and the impact on sports and play, rather than relying on surrogate measures like lung function or inflammatory markers, which are less relevant to patients.

Composite asthma control measures are limited in their usefulness for routine monitoring due to their short recall period and lack of focus on exacerbations, highlighting the need for a more personalized approach in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinician's guide on monitoring children with asthma. Brand, PL.[2013]

A study involving 90 children (60 with asthma and 30 with cystic fibrosis) demonstrated that digital biomarkers, such as physical activity, heart rate, sleep, and FEV1 measured by smartwatches and portable spirometers, can effectively capture clinical data in a home setting over 28 days.

The results indicated that these digital biomarkers could reliably reflect disease activity, with lower physical activity and FEV1 observed in patients compared to healthy children, suggesting their potential use in monitoring and managing pediatric lung diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical validation of digital biomarkers for paediatric patients with asthma and cystic fibrosis: potential for clinical trials and clinical care. Kruizinga, MD., Essers, E., Stuurman, FE., et al.[2022]

Digital technologies have been developed to improve asthma care in children and adolescents, with 70% of studies showing improved treatment adherence, indicating their potential effectiveness in supporting medication compliance.

However, the evidence for these technologies improving asthma control and health outcomes is mixed, highlighting the need for further research to understand their true impact and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technologies for Monitoring and Improving Treatment Adherence in Children and Adolescents With Asthma: Scoping Review of Randomized Controlled Trials. Milne-Ives, M., Lam, C., Meinert, E.[2021]

Asthma affects over 10% of children in Europe and North America, highlighting the need for effective diagnosis and monitoring methods, particularly through the use of non-invasive biomarkers.

The Pediatric Asthma Committee emphasizes the importance of implementing non-invasive biomarkers, such as fractional exhaled nitric oxide and spirometry, to improve asthma diagnosis and management in children, although their use in clinical practice remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of biomarkers in the diagnosis and monitoring of asthmatic children. Xepapadaki, P., Adachi, Y., Pozo Beltrán, CF., et al.[2023]

Ongoing monitoring is crucial for effectively managing asthma in children, but there is limited evidence on how to best integrate various monitoring components like symptoms, lung function, and inflammation.

A consensus from 22 experts highlighted the need for better tools and methods for monitoring asthma in children, as many aspects still lack sufficient evidence despite the recognized importance of monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring asthma in children. Pijnenburg, MW., Baraldi, E., Brand, PL., et al.[2022]

Research into different asthma phenotypes and endotypes in children is crucial for developing specific biomarkers that can improve diagnosis and treatment strategies.

Currently, most available biomarkers in pediatric asthma reflect type 2-high airway inflammation, but ongoing research aims to identify new noninvasive biomarkers to enhance personalized treatment approaches in childhood asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma Endotyping and Biomarkers in Childhood Asthma. Licari, A., Castagnoli, R., Brambilla, I., et al.[2020]

Recent developments in predictive asthma scores have introduced innovative features to assess asthma risk in infants and preschool children, with 12 models identified showing varied effectiveness.

Elevated levels of fractional concentration of nitric oxide (FeNO) are a strong risk factor for asthma in early wheezers, but more research is needed to establish its reliability compared to traditional clinical scores, while specific IgE and eosinophil counts remain the most consistent biomarkers for identifying at-risk children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of infants and preschool children at risk for asthma: predictive scores and biomarkers. Wandalsen, GF., Solé, D., Bacharier, LB.[2018]

In a study of 916 preschool children, the asthma predictive index (API) was found to be a useful tool for diagnosing current asthma, showing 72.2% sensitivity and 82.0% specificity.

Despite the association with the API, the study found no significant differences in lung function tests or other asthma-related markers like airway hyperreactivity or atopic sensitization between children with and without current asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma predictive index as a useful diagnostic tool in preschool children: a cross-sectional study in Korea. Lee, DH., Kwon, JW., Kim, HY., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

The clinician's guide on monitoring children with asthma. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Clinical validation of digital biomarkers for paediatric patients with asthma and cystic fibrosis: potential for clinical trials and clinical care. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Digital Technologies for Monitoring and Improving Treatment Adherence in Children and Adolescents With Asthma: Scoping Review of Randomized Controlled Trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Utility of biomarkers in the diagnosis and monitoring of asthmatic children. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Monitoring asthma in children. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Asthma Endotyping and Biomarkers in Childhood Asthma. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Identification of infants and preschool children at risk for asthma: predictive scores and biomarkers. [2018]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Asthma predictive index as a useful diagnostic tool in preschool children: a cross-sectional study in Korea. [2020]