N/A
Completed N=160
Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion
Skin Diseases · Skin Condition
Source: ClinicalTrials.gov NCT06237036 ↗
Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Clinical Utility Questionnaire (CUS) Score — 7.39 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Utility Questionnaire (CUS) Score |
7.39 | — |
| SECONDARY System Usability Scale (SUS) Score |
8.70 | — |
| SECONDARY Patient Satisfaction Questionnaire Score |
7.07 | — |
| SECONDARY Utility Questionnaire (DUQ) Score |
87.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have provided their informed consent for participation in the study.
- Patients who demonstrate proficiency in both written and spoken Spanish or English.
- Patients who possess a smartphone, defined as a phone equipped with internet access and an integrated camera, regardless of make, model, or technical specifications.
Exclusion Criteria
- Patients who, as determined by the investigator, did not adhere to the study procedures.
- Patients who were already utilizing the tool under investigation prior to the commencement of the study
Data sourced from ClinicalTrials.gov (NCT06237036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.