Ear Infection, Telemedicine
Conditions
Brief summary
System/Device name: Otoscopic recording and clinical data telemedicine software supporting its transmission and analysis. Characteristics of the medical device: The device is applied to an iPhone with a CE mark also from a CE-marked optical unit and the system operator, a consists of software under investigation.
Detailed description
The detailed operation is in the user guide in Hungarian included. The device makes a video recording of the external ear canal and about the tympanic membrane, and it records clinical data (symptoms, complaints). The telephone application sends the data through the system to a doctor, who, by analyzing them, makes a diagnosis and provides therapy. The study is a prospective, single-arm study. The specialist treating the real patient (called doctor 2) does not see or know the diagnosis and the therapy from the telemedicine system, or the recommendation from the telemedicine The diagnosis and therapeutic treatment established by the two methods are evaluated by an independent specialist and decides whether the primary diagnosis and therapeutic treatment are the same or not in the telemedicine system.
Interventions
DEVICEtelemedicine
Recording of the ear of each patient with an ear problem
Sponsors
University of Szeged, Hungary
Szeged University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent form * Patients with ear complaints (especially, but not exclusively, ear pain from the ear discharge, itching, cerumen accumulation,) * The subject communicates well with the investigator and is able to understand the requirements of the test plan and to help with compliance.
Exclusion criteria
* Poor general condition * Based on the investigator's decision, a condition that directly threatens life or a symptom that corresponds to these may indicate (e.g.: Liquor dripping, massive bleeding, etc.) * Any disease that, in the investigator's opinion, endangers the patient's health and/or contraindicates performing the test * The examiner finds that further participation is a disadvantage for the patient for any reason; * the patient requests the suspension of his participation orally or in writing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist. | 1 day | The primary objectives of the study is: number of matching cases, measured with the similarity and matching of International Classification of Diseases (ICD) codes. |
| Comparison of therapy | 1 day | Matching or similarity of prescribed therapy, e.g. same family of antibiotics , or the type of active substance. The match based on Anatomical Therapeutic Chemical (ATC) Classification |
Countries
Hungary
Outcome results
None listed