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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06062433
Other study ID # 22-001438
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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