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
NCT ID: NCT06062433
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2023-12-05
2025-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pediatric Asthma Intervention Group
Along with clinical standard of care for asthma, subjects will have Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) integrated into care.
AsthmaTuner
Phone application and spirometer for self-management of asthma
Asthma-Guidance and Prediction System
Artificial Intelligence (AI)-assisted clinical decision support system which extracts pertinent patient data related to asthma management from electronic health record
Pediatric Asthma Control Group
Subjects will receive clinical standard of care for asthma.
No interventions assigned to this group
Clinician Control Group
Clinicians will provide clinical standard of care for pediatric asthma patients.
No interventions assigned to this group
Clinician Intervention Group
Clinicians will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma.
AsthmaTuner
Phone application and spirometer for self-management of asthma
Asthma-Guidance and Prediction System
Artificial Intelligence (AI)-assisted clinical decision support system which extracts pertinent patient data related to asthma management from electronic health record
Asthma Care Coordinator Control Group
Asthma Care Coordinators will provide clinical standard of care for pediatric asthma patients.
No interventions assigned to this group
Asthma Care Coordinator Intervention Group
Asthma Care Coordinators will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma.
AsthmaTuner
Phone application and spirometer for self-management of asthma
Asthma-Guidance and Prediction System
Artificial Intelligence (AI)-assisted clinical decision support system which extracts pertinent patient data related to asthma management from electronic health record
Interventions
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AsthmaTuner
Phone application and spirometer for self-management of asthma
Asthma-Guidance and Prediction System
Artificial Intelligence (AI)-assisted clinical decision support system which extracts pertinent patient data related to asthma management from electronic health record
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* 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.
Exclusion Criteria
* 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.
6 Years
17 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Young Juhn
Principal Investigator
Principal Investigators
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Young Juhn, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-001438
Identifier Type: -
Identifier Source: org_study_id
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