Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.
* 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.

Primary outcomes:
measure: Change in satisfaction of asthma care
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Time allocated to asthma visits
timeFrame: 6 months
measure: Number of on-site visits
timeFrame: 6 months
measure: Frequency of poorly controlled asthma
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Young Juhn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: