Diagnostik Platform for Childhood Asthma and Ear Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma and ENT conditions. Participants will be assigned to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person care.
The primary objective is to assess agreement between AI-generated diagnoses and clinician diagnoses obtained during study encounters, including telehealth evaluations in the Diagnostik arm and in-person evaluations in the standard-of-care arm. Secondary objectives include evaluating agreement between AI-generated diagnoses and independent research team diagnoses, as well as assessing usability, patient and caregiver satisfaction, healthcare utilization, and clinical outcomes such as asthma control and symptom resolution.
This study will also evaluate differences in healthcare utilization, including in-person visits, emergency care use, and time to diagnosis and treatment, between study groups.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person care for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including data collection through platform data, medical record review, and patient-reported outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Medentum Diagnostik Platform
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Intervention Group with in-office standard of care for routine well visits, urgent care/ED visits as needed plus using the Medentum Diagnostik platform for telehealth for ENT conditions
Intervention Group with in-office standard of care for routine well visits, urgent care/ED visits as needed plus using the Medentum Diagnostik platform (multisensor device, + app+ AI platform) for telehealth management of asthma
Control Group receiving in-office standard of care for routine well visits, and urgent care/ED visits as needed. No Diagnostik platform use.
Control Group receiving in-office standard of care for routine well visits, and routine care, urgent care/ED visits as needed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medentum Innovations
Lead Sponsor
University of Arizona
Collaborator
National Institutes of Health (NIH)
Collaborator
El Rio Community Health Center
Collaborator
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