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

Asthma in Children Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06062433
• Other study ID #: 22-001438
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Device:
• AsthmaTuner
Phone application and spirometer for self-management of asthma

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of on-site visits	Total number of on-site visits for related asthma care	6 months
Secondary	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