Asthma in ChildrenNCT06062433
A Study of Remote Asthma Management Using an Integrated Artificial Intelligence-assisted EHR Dashboard and Mobile Device Compared With Usual Asthma Care to Treat 6-17 Year Old Patients
A study testing AsthmaTuner and Asthma-Guidance and Prediction System in people with Asthma in Children, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- AsthmaTuner and Asthma-Guidance and Prediction System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 5 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinician participants are eligible to be included in the study only if all of the following criteria apply:
- Employed as consultant or nurse practitioner at study sites.
- Able to provide written consent.
- Are willing to follow recommendations to schedule/see participant and their caregiver for regular asthma follow-up care every 3-6 months.
- 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:
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- Ages 6-17 years old with diagnosis of asthma.
- Have a caregiver who is willing to participate alongside pediatric participant and to have regular asthma follow-up care every 3-6 months.
- Adolescent participants ages 13-17 years and their caregivers are able to give written informed consent; or child participants ages 7-12 years are able to provide assent and their caregivers are able to give written informed consent (subjects who are 6 years old will be waived).
- Both participant and caregiver are able to read and write in English.
- Receive pediatric primary care at study sites from participating study clinician.
- Access for caregiver and/or adolescent participants to an Android or iPhone with Wi-Fi access and availability for at least monthly use.
- Active asthma defined by at least one clinic visit with a diagnosis of asthma per EHR or on active asthma control or rescue medication in the past 12 months. Priority will be given to those with persistent asthma on inhaled corticosteroids therapy or those with poorly controlled asthma defined by any of the following criteria in the past 12 months, except item v (past 2-week period); i. Asthma Control Test for adolescents ≥ 12 years or Childhood Asthma Control Test for children < 12 years (score< 20); ii. ED visit for asthma; or iii. Hospitalization for asthma; or iv. Unscheduled outpatient visit for asthma requiring oral corticosteroid use; or v. Asthma symptoms at the screening interview, including 1) more than 2 days per week shortness of breath, wheezing, chest tightness, or 2) more than 1 night awakening due to asthma in the past 2-week period.
- Participant had their latest asthma follow-up visit more than 3 months prior to the screening date of the study.
Who cannot join
- 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:
- Major medical problems prohibiting study participation and inability to perform study procedures (including spirometry); suspected symptoms of exercise-induced laryngeal obstruction (EILO), tracheobronchial foreign body at or about the incidence date of asthma, wheezing occurring only in response to anesthesia or medications, bullous emphysema or pulmonary fibrosis on chest radiograph, PiZZ alpha1-antitrypsin, cystic fibrosis, or other major chest disease such as severe kyphoscoliosis or bronchiectasis.
- Pediatric participant pregnancy.
- Hyposensitization therapy for > 3 months prior to study enrollment.
- Participation in any other interventional studies for asthma within 1 month prior to study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Feasibility and Effectiveness of Remote Asthma Management Via an Integrated Artificial Intelligence-assisted Clinical Decision Support System With Mobile Device Compared With Usual Asthma Care in Pediatric Participants With Asthma Aged 6-17 Years: A Parallel Group, Non-blinded, Dual-site, 2-arm, Pragmatic Randomized Clinical Trial
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.
- Conditions
- Asthma in Children
- Being tested
- AsthmaTuner, Asthma-Guidance and Prediction System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsthmaTunerDevice
Also called AT
Phone application and spirometer for self-management of asthma
Asthma-Guidance and Prediction SystemOther
Also called A-GPS
Artificial Intelligence (AI)-assisted clinical decision support system which extracts pertinent patient data related to asthma management from electronic health record
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AsthmaTuner; Other: Asthma-Guidance and Prediction System |
| 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. Receives: Device: AsthmaTuner; Other: Asthma-Guidance and Prediction System |
| 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 | Experimental | Asthma Care Coordinators will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma. Receives: Device: AsthmaTuner; Other: Asthma-Guidance and Prediction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Satisfaction of Asthma Care
Measured by a single question to assess satisfaction about asthma care using a Likert scale where 1=strongly disagree and 5=strongly agree. Total scores range from 1 to 5, with higher scores indicates greater satisfaction.
Measured: Baseline, 6 months
Secondary outcomes (3)
Estimated Clinician Preparation Time for Asthma Visits
The number of minutes it took a clinician to review a patient's relevant medical information in preparation for their treatment visit.
Measured: 6 Months
Change in the Number of Subjects With Poorly Controlled Asthma
The change in the number of subjects to have poorly controlled asthma defined as Asthma Control Test or Childhood Asthma Control Test score less than 20.
Measured: Baseline, 6 months
Number of On-site Visits
Total number of on-site visits participants completed for related asthma care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start5 Dec 2023
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
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 Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Juhn, Mayo Clinic
- Investigators
- Young Juhn, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062433
- Sponsor's protocol ID
- 22-001438
- Status last verified
- May 2026
- First submitted
- 25 Sep 2023
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41453519
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Feasibility and Effectiveness of Remote Asthma Management Via an Integrated Artificial Intelligence-assisted Clinical Decision Support System With Mobile Device Compared With Usual Asthma Care in Pediatric Participants With Asthma Aged 6-17 Years: A Parallel Group, Non-blinded, Dual-site, 2-arm, Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06062433
- Acronym / sponsor ID
- 22-001438
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pediatric Asthma Intervention Group | Experimental | Device: AsthmaTuner, Other: Asthma-Guidance and Prediction SystemAlong 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 | Device: AsthmaTuner, Other: Asthma-Guidance and Prediction SystemClinicians 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 | Experimental | Device: AsthmaTuner, Other: Asthma-Guidance and Prediction SystemAsthma Care Coordinators will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Clinician participants are eligible to be included in the study only if all of the following criteria apply:
- Employed as consultant or nurse practitioner at study sites.
- Able to provide written consent.
- Are willing to follow recommendations to schedule/see participant and their caregiver for regular asthma follow-up care every 3-6 months.
- All asthma care coordinators who are involved in the usual care of pediatric participants will also be recruited for inclusion in the study.
Key exclusion criteria (5 listed)
- 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:
- Major medical problems prohibiting study participation and inability to perform study procedures (including spirometry); suspected symptoms of exercise-induced laryngeal obstruction (EILO), tracheobronchial foreign body at or about the incidence date of asthma, wheezing occurring only in response to anesthesia or medications, bullous emphysema or pulmonary fibrosis on chest radiograph, PiZZ alpha1-antitrypsin, cystic fibrosis, or other major chest disease such as severe kyphoscoliosis or bronchiectasis.
- Pediatric participant pregnancy.
- Hyposensitization therapy for > 3 months prior to study enrollment.
- Participation in any other interventional studies for asthma within 1 month prior to study.
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 |
|---|---|---|
| AsthmaTunerAlso: ATPhone application and spirometer for self-management of asthma | Device | Asthma Care Coordinator Intervention Group, Clinician Intervention Group, Pediatric Asthma Intervention Group |
| Asthma-Guidance and Prediction SystemAlso: A-GPSArtificial Intelligence (AI)-assisted clinical decision support system which extracts pertinent patient data related to asthma management from electronic health record | Other | Asthma Care Coordinator Intervention Group, Clinician Intervention Group, Pediatric Asthma Intervention Group |
Primary outcome
Change in Satisfaction of Asthma Care
Time frame: Baseline, 6 months
Measured by a single question to assess satisfaction about asthma care using a Likert scale where 1=strongly disagree and 5=strongly agree. Total scores range from 1 to 5, with higher scores indicates greater satisfaction.
3 secondary outcomes
Estimated Clinician Preparation Time for Asthma Visits
Time frame: 6 Months
Change in the Number of Subjects With Poorly Controlled Asthma
Time frame: Baseline, 6 months
Number of On-site Visits
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41453519Myers 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Young Juhn, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AsthmaTuner and Asthma-Guidance and Prediction System in people with Asthma in Children, run by Mayo Clinic 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 14 inclusion and 5 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: finished, as of the sponsor's last update on 22 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 22 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?
Change in Satisfaction of Asthma Care (time frame: Baseline, 6 months). 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 NCT06062433, 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 22 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.