Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorMedentum Innovations
About 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.
Eligibility criteria
Qualifiers
Age: Patients between the ages of 4 and 17 years (asthma) and 3-17 years (ENT)
Technology access: Must have access to a smartphone, tablet, or other device capable of running the Medentum Diagnostik platform app and access to Wifi or cellular service.
Care access: Must be receiving routine care from University of Arizona or associated clinics in Arizona and have active health insurance
Consent: Must have parental or guardian consent for participation, as well as child assent when appropriate.(all children ≥7 yrs)
Disqualifiers
Other medical conditions: Patients with additional chronic lung diseases (such as cystic fibrosis) requiring complex specialist care will be excluded. cerebral palsy, neurodevelopmental conditions, congenital heart disease. Patients with complex chronic conditions or chronic ENT conditions requiring complex specialist care will be excluded.
Recent surgical/complex ENT medical history: Patients who have had tympanostomy tubes or tonsillectomy/adenoidectomy, patients with chronic ENT conditions including chronic suppurative or serous otitis media
Recent medical history: Patients who have experienced severe asthma exacerbations requiring hospitalization or intensive treatment in the past 4 weeks
Comorbidities: Patients with speech delays, hearing impairments, or cognitive impairments that may affect their ability to use the Diagnostik platform accurately will be excluded.
Trial design
Treatments tested in this trial
- Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis
- Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation
- Routine Asthma Management (in-person and telehealth visits)- Control Group
- Routine ENT Management (in-person and telehealth visits)- Control Group
Treatment groups
84 Participants
are divided into 4 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
El Rio Health SystemRecruiting85745, Tuscon, Arizona
United States
United StatesSponsors and collaborators
Medentum Innovations
Lead sponsor
University of Arizona
Collaborator
National Institutes of Health (NIH)
Collaborator
El Rio Community Health Center
Collaborator
Source ClinicalTrials.gov