Real-world Observation of Medical Accuracy of a Novel AI-app

Completed

• Conditions: Cardiovascular Issues; Genitourinary Issues; Gastrointestinal Issues; ENT Issues; Eye Issues; Neurologic Issues; Respiratory Issues; Musculoskeletal Issues; Mental Health Issues

• Registration Number: NCT05194215
• Lead Sponsor: Ada Health GmbH

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.

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study Start: 2022-01-06
• Study First Posted: 2022-01-18
• Primary Completion: 2022-07-07
• Study Completion: 2022-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy and comprehensiveness of the Ada WRA	about 5 months to gather the data	Accuracy and comprehensiveness of the Ada WRA assessment evaluated against the gold standard differential diagnosis from the panel.

Secondary Outcome Measures

Name	Time	Method
Accuracy and comprehensiveness of the family practitioner	about 5 months to gather the data	Accuracy and comprehensiveness of the family practitioner's differential diagnosis evaluated against the gold standard differential diagnosis from the panel.
Qualitative data on the chronology usability, usefulness and acceptance	about 3 months to gather the data	Gathered from surveys from patient, study nurse, and doctor

Trial Locations

Locations (1)

Dr. Claudia Pîrșan; 🇷🇴 Cluj-Napoca, Romania