Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma

Condition(s) studied

Investigational drug(s) / intervention(s)

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 AOM and strep pharyngitis

Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation: 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: * Patients randomized to the control group will receive standard care through routine in-office visits or telehealth visits. * Patients in the control group will visit the clinic whenever they experience symptoms related to their asthma condition or any other non-respiratory, non-ENT medical condition. * Telehealth visits will be offered as per routine and determined by the medical provider. * Asthma patients will undergo a physical exam, and other lab studies (e.g. Covid, strep tests) as determined by the provider to aid in diagnosis and treatment plan. The medical provider will make a diagnosis based on these routine in-office or telehealth assessments. * Control group patients will have routine well-care in-office follow-ups at a frequency as determined by their routine provider.

Routine ENT Management (in-person and telehealth visits)- Control Group: * Patients randomized to the control group will receive standard care through routine in-office visits or telehealth visits. * Patients in the control group will visit the clinic whenever they experience symptoms related to their ENT condition or any other non-respiratory, non-ENT medical condition. * Telehealth visits will be offered as per routine and determined by the medical provider. * ENT patients will undergo a physical exam, and other lab studies (e.g. Covid, strep tests) as determined by the provider to aid in diagnosis and treatment plan. The medical provider will make a diagnosis based on these routine in-office or telehealth assessments. * Control group patients will have routine well-care in-office follow-ups at a frequency as determined by their routine provider.

Study summary

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

Primary outcome measure(s)

• Diagnostic concordance between AI and physician/clinician — 6 months
  Arms and Interventions: Participants will be randomized to (1) home-based use of the Diagnostik device with telehealth-supported clinician evaluation or (2) in-clinic standard-of-care evaluation. Primary Outcome: Agreement between AI-generated diagnosis and clinician diagnosis obtained during the study encounter. Clinician diagnosis will be determined via telehealth evaluation in the Diagnostik arm and in-person standard-of-care evaluation in the control arm. Participants will use the Diagnostik device to collect lung auscultation recordings via digital stethoscope and capture ear or throat images. AI algorithms will assess lung sounds for presence or absence of wheeze and images for acute otitis media and pharyngitis. Clinicians will establish diagnoses based on their respective evaluation modality. Agreement between AI and clinician diagnoses will be assessed separately for asthma and ENT conditions using percent agreement and Cohen's kappa. A concordance rate ≥85% is anticipated.

Trial sites (1)

Other trials for the same condition