ESSENCE is a Quality Improvement Study That Evaluates the Impact of Ada's AI-powered Core Symptom Assessment Technology on Clinical Workflow and Individual Healthcare Guidance, Following the November 2021 Integration of the Tool Into the CUF Hospital Network. Study Duration Nov 2024-Oct 2025

NCT06846957 | Completed

• 1 other identifier: EudraCT number: 2022-000067-42
• Study Type: observational
• Target: 1,470
• Locations: 1 country
• Sites: 1

Brief Summary

A 1.5.1 Study title ESSENCE Study: E-health Self Symptom assEssmeNt as a front door and facilitator of CarE A 1.5.2 Investigational device 'Ada Assess' (CE-marked), 'Ada Connect' (a software integrating with CE-marked medical devices), and 'Ada Handover' (a CE-marked component of the 'Ada Assess' product that shares the same version number). A 1.5.3 The Ada Health-CUF Integration To improve MyCUF service, CUF partnered with Ada Health, a symptom assessment application in which the patient can enter their/their children's symptoms, answer follow-up questions, and receive a list of potential causes, additional health information, and advice on if, when, and where to seek medical care. A 1.5.4 Study design ESSENCE is a Quality Improvement (QI) study that evaluates the impact of Ada's AI-powered core symptom assessment technology on clinical workflow and individual healthcare guidance, following the November 2021 integration of the tool into the CUF hospital network. A 1.5.5 Study objectives The study has 3 main objectives:

1. 1.Assess the clinician-perceived appropriateness of the Ada symptom assessment report.
2. 2.Examine the impact of the Ada symptom assessment report on consultation efficiency.
3. 3.Evaluate the effect of the Ada symptom assessment on patients' health-seeking behavior.

Conditions

Symptom Assessment

Keywords

digital health; AI; patient outcomes; symptom assessment application; symptom checker; Ada; CUF; Portugal; ESSENCE

Outcome Measures

Primary Outcomes (1)

• Accuracy of ada's condition report and triage classification

  1. Appropriateness of Ada's urgency advice 2. Appropriateness of the 'Ada Symptom Assessment Report,' considering all information points provided. This will be a composite of ratings on 1. Reasonability of the suggested conditions, 2. Completeness rating on symptom/medical history, 3. Agreement of the medical problem presented in the Assessment Report with the presentation in the patient-HCP consultation

  12 months

Secondary Outcomes (1)

• Impact of Ada on patient and physician healthcare behaviours

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any individual who is 18 years old or above and utilises the CUF application to evaluate their own symptoms using 'Ada Assess' and who consents to participate in this clinical investigation and to Ada 'Handover'.

You may qualify if:

• Any individual who is 18 years old or above and utilises the CUF application to evaluate their own symptoms using 'Ada Assess' and who consents to participate in this clinical investigation and to Ada 'Handover'.

You may not qualify if:

• Users under the age of 18 years will be excluded. Users who conduct a symptom assessment on behalf of others will be excluded. Users who do not consent to sharing the symptom assessment report with CUF will be excluded.

Sponsors & Collaborators

• Ada Health GmbH: lead
• Academia Cuf Descobertas: collaborator
• Hospital CUF Descobertas, Lisbon, Portugal: collaborator
• CUF Tejo Hospital: collaborator

Study Sites (1)

CUF Hospital Network

Lisbon, Carnaxide, 2790-073, Portugal

Location

Study Officials

• Pedro Flores, MD

  CUF hospital Network

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: November 8, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)