Clinical trial NCT05194215: Real-world Observation of Medical Accuracy of a Novel AI-app
Official title: Real-world Observation of Medical Accuracy of a Novel AI-app
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Issues
Respiratory Issues
Cardiovascular Issues
Genitourinary Issues
Musculoskeletal Issues
ENT Issues
Eye Issues
Neurologic Issues
Mental Health Issues
Lead sponsor: Ada Health GmbH
Sponsor class: INDUSTRY
Collaborators: name: Babes-Bolyai University
name: Botnar Foundation
First posted: 2022-01-18
Enrollment: 49
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be from the area of Cluj-Napoca, Romania and will be coming into their normal GP's office for a regular appointment.

Brief summary: This study aims to evaluate the performance of the suggestions made by the WRA by comparing Ada's list of suggested conditions and advice level to usual care and a gold-standard in a Romanian clinical setting.

Detailed description: This pilot study investigates the performance of the Romanian version of Ada's Waiting Room Application in a clinical setting. The study will take place in a family doctor's practice in Cluj-Napoca, Romania. While waiting for their consultation with a family doctor, participants will complete an Ada assessment. The results of this assessment will not be available for viewing by the participants or the family practitioner. During and after consultation, the family practitioner will create two top 5 differential diagnoses list--one based on symptoms only and one based on physical examination and investigation results. The accuracy and comprehensiveness of Ada's differential diagnoses will be compared against the family practitioner's and a gold-standard.

Eligibility criteria: Inclusion Criteria:

* All patients under 60 years of age that enter the study sites and that are willing/able to provide consent will be included in the study, unless exclusion criteria are met.

Exclusion Criteria:

* Patients with severe injury/illness requiring immediate treatment
* Patients with traumatic injury
* Patients incapable of completing a health assessment (e.g. due to illiteracy, mental impairment or inebriation or other incapacity)
* Patients that are unfamiliar with mobile applications
* Patients that are seeking treatment for a chronic condition

Primary outcomes:
measure: Accuracy and comprehensiveness of the Ada WRA
timeFrame: about 5 months to gather the data
Secondary outcomes:
measure: Accuracy and comprehensiveness of the family practitioner
timeFrame: about 5 months to gather the data
measure: Qualitative data on the chronology usability, usefulness and acceptance
timeFrame: about 3 months to gather the data
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Dr. Claudia Pîrșan
Study officials:
affiliation: Cluj School of Public Health
name: Marius-Ionuț Ungureanu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cluj School of Public Health
name: Madalina A Coman, PhD
role: PRINCIPAL_INVESTIGATOR
References: