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OpenTrials
Completed

NCT Number: NCT05194215

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

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.

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Key information

Conditions

Gastrointestinal Issues Cardiovascular Issues ENT Issues Eye Issues Genitourinary Issues Mental Health Issues Musculoskeletal Issues Neurologic Issues Respiratory Issues

Age range

2 month–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Claudia Pîrșan

Cluj-Napoca, 400102, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ada WRA

Device

The Ada WRA is a study-only device based on the Ada mobile app. The patient will use this device to answer questions regarding their symptoms but will not be given any feedback by the app.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Ada Health GmbH

Industry

Collaborators

  • Babes-Bolyai University
  • Botnar Foundation

Registry information

Acronym: ROMAN-AI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2022
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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