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The main purpose of this study is to look at whether clinicians and their patients with asthma can satisfactorily perform remote asthma management at home (not visiting clinic) by using an artificial intelligence tool called Asthma-Guidance and Prediction System combined with a home monitoring device called AsthmaTuner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric Asthma Intervention Group | Experimental | Along with clinical standard of care for asthma, subjects will have Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) integrated into care. |
|
| Pediatric Asthma Control Group | No Intervention | Subjects will receive clinical standard of care for asthma. | |
| Clinician Control Group | No Intervention | Clinicians will provide clinical standard of care for pediatric asthma patients. | |
| Clinician Intervention Group | Experimental | Clinicians will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma. |
|
| Asthma Care Coordinator Control Group | No Intervention | Asthma Care Coordinators will provide clinical standard of care for pediatric asthma patients. | |
| Asthma Care Coordinator Intervention Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AsthmaTuner | Device | Phone application and spirometer for self-management of asthma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in satisfaction of asthma care | Measured by single question to assess satisfaction about asthma care using a Likert scale where 1=strongly disagree and 5=strongly agree. Higher score indicates greater satisfaction. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time allocated to asthma visits | Total time allocated to asthma visits which includes time spent with pediatric participant, EHR review, and completion of timed clinical task. | 6 months |
| Number of on-site visits |
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Inclusion Criteria:
Clinician participants are eligible to be included in the study only if all of the following criteria apply:
All asthma care coordinators who are involved in the usual care of pediatric participants will also be recruited for inclusion in the study.
Pediatric participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Pediatric participants who do not meet the eligibility criteria described above will be excluded and those will be excluded from the study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Young Juhn, MD, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41453519 | Derived | Myers L, Brereton TA, Overgaard S, Greenwood JD, Zheng L, Ohde JW, Spiten M, Kathy Ihrke RN, Lang K, Peterson K, Hawley S, Beenken M, Malik M, Bublitz J, Galloway T, Wilkes Q, Shrader D, Mercado L, Park M, Arteta M, Hartz M, Fladager-Muth J, Quam M, Perrigo T, Loufek T, Khurana A, Kshatriya BSA, Sharma D, Le-Rademacher J, Wi CI, Nordlund B, Juhn Y. Pediatric asthma management via integration of a remote spirometry device into an EHR-based artificial intelligence-powered clinical decision support system: A feasibility pragmatic clinical trial. Contemp Clin Trials. 2026 Feb;161:108209. doi: 10.1016/j.cct.2025.108209. Epub 2025 Dec 24. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Asthma Care Coordinators will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma. |
|
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| Asthma-Guidance and Prediction System | Other | Artificial Intelligence (AI)-assisted clinical decision support system which extracts pertinent patient data related to asthma management from electronic health record |
|
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Total number of on-site visits for related asthma care
| 6 months |
| Frequency of poorly controlled asthma | Number of subjects to have poorly controlled asthma defined as Asthma Control Test or Childhood Asthma Control Test score less than 20. | Baseline, 6 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 10, 2026 | Jun 5, 2026 | 6 | ||
| Jun 23, 2026 |