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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Device: AsthmaTuner; Other: Asthma-Guidance and Prediction System

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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:

• 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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: AsthmaTuner; Phone application and spirometer for self-management of asthma; Other Names: AT; Other: 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 Names: A-GPS
No Intervention: Pediatric Asthma Control Group; Subjects will receive clinical standard of care for asthma.
No Intervention: Asthma Care Coordinator Control Group; Asthma Care Coordinators will provide clinical standard of care for pediatric asthma patients.
Experimental: 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.	Device: AsthmaTuner; Phone application and spirometer for self-management of asthma; Other Names: AT; Other: 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 Names: A-GPS
No Intervention: Clinician Control Group; Clinicians will provide clinical standard of care for pediatric asthma patients.
Experimental: Clinician Intervention Group; Clinicians will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma.	Device: AsthmaTuner; Phone application and spirometer for self-management of asthma; Other Names: AT; Other: 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 Names: A-GPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Young Juhn, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 22-001438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No