Gastrointestinal IssuesROMAN-AINCT05194215
Real-world Observation of Medical Accuracy of a Novel AI-app
An observational study of Gastrointestinal Issues and Respiratory Issues, run by Ada Health GmbH at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 60 years
- Conditions the study is for
- Gastrointestinal Issues, Respiratory Issues, Cardiovascular Issues
- What is being tested?
- Ada WRA
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteRomania
- Study dates
- 6 Jan 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gastrointestinal Issues, Respiratory Issues, Cardiovascular Issues, Genitourinary Issues, Musculoskeletal Issues, ENT Issues
- Being tested
- Ada WRA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ada WRADevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and comprehensiveness of the Ada WRA
Accuracy and comprehensiveness of the Ada WRA assessment evaluated against the gold standard differential diagnosis from the panel.
Measured: about 5 months to gather the data
Secondary outcomes (2)
Accuracy and comprehensiveness of the family practitioner
Accuracy and comprehensiveness of the family practitioner's differential diagnosis evaluated against the gold standard differential diagnosis from the panel.
Measured: about 5 months to gather the data
Qualitative data on the chronology usability, usefulness and acceptance
Gathered from surveys from patient, study nurse, and doctor
Measured: about 3 months to gather the data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start6 Jan 2022
- Primary completion7 Jul 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ada Health GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Babes-Bolyai University, Botnar Foundation
- Responsible party
- Sponsor
- Investigators
- Marius-Ionuț Ungureanu, MD, PhD, Principal investigator, Cluj School of Public HealthMadalina A Coman, PhD, Principal investigator, Cluj School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194215
- Sponsor's protocol ID
- ROMAN-AI
- Acronym
- ROMAN-AI
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared if there is a reasonable request and this request is approved by the IRB in charge of the study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Observation of Medical Accuracy of a Novel AI-app
- ClinicalTrials.gov ID
- NCT05194215
- Acronym / sponsor ID
- ROMAN-AI / ROMAN-AI
- Conditions
- Gastrointestinal Issues, Respiratory Issues, Cardiovascular Issues, Genitourinary Issues, Musculoskeletal Issues, ENT Issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ada Health GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Babes-Bolyai University, Botnar Foundation
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ada WRAThe 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. | Device | – |
Primary outcome
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.
2 secondary outcomes
Accuracy and comprehensiveness of the family practitioner
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Undecided. IPD will be shared if there is a reasonable request and this request is approved by the IRB in charge of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius-Ionuț Ungureanu, MD, PhD principal investigator
Cluj School of Public Health
Madalina A Coman, PhD principal investigator
Cluj School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Issues and Respiratory Issues, run by Ada Health GmbH at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and comprehensiveness of the Ada WRA (time frame: about 5 months to gather the data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.