Real-world Observation of Medical Accuracy of a Novel AI-app (ROMAN-AI)

March 12, 2024 updated by: Ada Health GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Romania
      • Cluj-Napoca, Romania, 400102
        • Dr. Claudia Pîrșan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy and comprehensiveness of the Ada WRA
Time Frame: 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.
about 5 months to gather the data

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy and comprehensiveness of the family practitioner
Time Frame: 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.
about 5 months to gather the data
Qualitative data on the chronology usability, usefulness and acceptance
Time Frame: about 3 months to gather the data
Gathered from surveys from patient, study nurse, and doctor
about 3 months to gather the data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ada Health GmbH

Collaborators

Babes-Bolyai University
Botnar Foundation

Investigators

  • Principal Investigator: Marius-Ionuț Ungureanu, MD, PhD, Cluj School of Public Health
  • Principal Investigator: Madalina A Coman, PhD, Cluj School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Actual)

July 7, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ROMAN-AI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD will be shared if there is a reasonable request and this request is approved by the IRB in charge of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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