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OpenTrials
Completed

NCT Number: NCT06062433

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

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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Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AsthmaTuner

Device

Phone application and spirometer for self-management of asthma

Other names: AT

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

Other names: A-GPS

Primary outcomes

  1. 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.

Secondary outcomes

  1. Estimated Clinician Preparation Time for Asthma Visits

    Time frame: 6 Months

    The number of minutes it took a clinician to review a patient's relevant medical information in preparation for their treatment visit.

  2. Change in the Number of Subjects With Poorly Controlled Asthma

    Time frame: Baseline, 6 months

    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.

  3. Number of On-site Visits

    Time frame: 6 months

    Total number of on-site visits participants completed for related asthma care

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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