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

Mayo Clinic1 site in 1 country47 target enrollmentDecember 5, 2023

ConditionsAsthma in Children

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma in Children
Sponsor: Mayo Clinic
Enrollment: 47
Locations: 1
Primary Endpoint: Change in satisfaction of asthma care
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 5, 2023

End Date

June 5, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Young Juhn

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Change in satisfaction of asthma care

Time Frame: Baseline, 6 months

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.