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

NCT06062433 | Completed FDA Device

• 1 other identifier: 22-001438
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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 AsthmaTuner.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time allocated to asthma visits

  6 months

• Number of on-site visits

  6 months

• Frequency of poorly controlled asthma

  Baseline, 6 months

Study Arms (6)

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.

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.

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.

Device: AsthmaTuner; Other: Asthma-Guidance and Prediction System

Interventions

AsthmaTuner DEVICE

Phone application and spirometer for self-management of asthma

Also known as: AT

Asthma Care Coordinator Intervention Group; Clinician Intervention Group; Pediatric Asthma Intervention Group

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

Also known as: A-GPS

Asthma Care Coordinator Intervention Group; Clinician Intervention Group; Pediatric Asthma Intervention Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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. 2025 Dec 24;161:108209. doi: 10.1016/j.cct.2025.108209. Online ahead of print.

  PMID: 41453519 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Young Juhn, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: December 5, 2023
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)