NCT05194215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

January 6, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

January 4, 2022

Last Update Submit

March 12, 2024

Conditions

Gastrointestinal IssuesRespiratory IssuesCardiovascular IssuesGenitourinary IssuesMusculoskeletal IssuesENT IssuesEye IssuesNeurologic IssuesMental Health Issues

Outcome Measures

Primary Outcomes (1)

  • 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.

    about 5 months to gather the data

Secondary Outcomes (2)

  • Accuracy and comprehensiveness of the family practitioner

    about 5 months to gather the data

  • Qualitative data on the chronology usability, usefulness and acceptance

    about 3 months to gather the data

Interventions

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.

Eligibility Criteria

Age2 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Claudia Pîrșan

Cluj-Napoca, 400102, Romania

Location

Study Officials

  • Marius-Ionuț Ungureanu, MD, PhD

    Cluj School of Public Health

    PRINCIPAL INVESTIGATOR

  • Madalina A Coman, PhD

    Cluj School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 18, 2022

Study Start

January 6, 2022

Primary Completion

July 7, 2022

Study Completion

December 30, 2022

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations

RO(1)