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Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion

NCT06237036 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2026-03-19

Study results available
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Summary

The goal of this observational study is to learn if an artificial intelligence (AI) tool, called Legit Health Plus, can track the severity of chronic skin conditions from a distance. The study included 160 participants who have various skin issues, such as acne, psoriasis, or atopic dermatitis (a type of eczema). The main questions it aims to answer are:

* Can this computer-aided diagnosis (CAD) system reliably track how a person's skin condition changes over time?
* Does using the tool lead to fewer in-person doctor visits?
* Are participants satisfied with using the tool at home?

Because this study focuses on evaluating the tool in a real-world setting, researchers did not use a comparison group.

What Participants Will Do

Participants will use a smartphone app for 6 months to help their doctors monitor their skin. They will:

* Take photos of their skin with their own smartphones and send them to their doctor through the app.
* Answer survey questions about their symptoms and how the condition affects their daily life.
* Complete surveys every two months to share if they are satisfied with the tool and if it is easy to use.

How Utility and Usability are Assessed

After the study, researchers and doctors will assess if the tool is practical and helpful for medical practice using several methods:

* Clinical Utility Questionnaire (CUS): Doctors use this to rate how well the AI tool tracks disease progression and helps them prioritize which participants need care first.
* Time Tracking: Researchers check if the tool lowers the time doctors spend on visits, allowing them to manage their workload more efficiently.
* System Usability Scale (SUS): Both doctors and participants use this to rate if the app is easy to navigate, simple to learn, and not too complex.
* Data Utility Questionnaire (DUQ): Doctors judge if the information collected by the app is useful for their regular practice and remote consultations.

Conditions

  • Skin Diseases
  • Skin Condition

Sponsors & Collaborators

  • University Hospital of Torrejon

    collaborator OTHER

  • Ribera Salud Hospitals, Spain

    collaborator UNKNOWN

  • AI Labs Group S.L

    lead INDUSTRY

Principal Investigators

  • Marta Andreu, MD · Torrejón University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2023-10-23
Completion
2023-10-23

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237036 on ClinicalTrials.gov