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

NCT06237036 | Completed Results

• 2 other identifiers: LEGIT_COVIDX_EVCDAO_2022EUPAS108260
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dermatology; Skin lesions; Dermatologist; Artificial Intelligence; Chronic illness

Outcome Measures

Primary Outcomes (1)

• Clinical Utility Questionnaire (CUS) Score

  The Clinical Utility Questionnaire (CUS) is a 13-item instrument assessing the practical value of the Legit.Health Plus device. Scale Ranges: Items 1-10 use a 0-10 Likert scale (0=lowest utility, 10=highest). Items 11-12 are binary, scored as 0 (No) or 10 (Yes). Item 13 is categorical, scored as 0, 4, 8, or 10 based on the amount of consultation time saved. Calculation Method: The Total Raw Score is the sum of all 13 items (Minimum: 0; Maximum: 130). This raw sum is normalized to a 10-point scale using the formula: (Total Raw Score / 130) × 10. Interpretation: The final result is reported as a score from 0 to 10. Higher scores indicate greater perceived clinical utility. A score of 8.0 or higher was the pre-specified threshold for successful validation of the device's utility.

  At the conclusion of the study evaluation period, up to 18 months.

Secondary Outcomes (3)

• System Usability Scale (SUS) Score

  Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).

• Patient Satisfaction Questionnaire Score

  Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).

• Utility Questionnaire (DUQ) Score

  Collected once at the end of the 6-month follow-up period for each participant.

Study Arms (1)

Patients with the specified chronic dermatological conditions

The study encompasses patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón. Treatment Patients participating in this study did not receive any specific treatment as part of the research protocol. Concomitant Medication/Treatment Patients continued their regular prescribed medications and treatments as directed by their primary healthcare providers. No additional medications or treatments were administered as part of this study. Follow-Up Duration The follow-up period extended for seven months. Throughout this duration, patients underwent a minimum of two follow-up visits, which could be conducted either remotely or in-person, as per the study\'s protocol.

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

patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón. It encompassed a diverse patient cohort with a range of chronic dermatologic pathologies, providing a comprehensive representation of the population affected by these conditions.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ribera Salud Hospitals, Spain: collaborator
• AI Labs Group S.L: lead
• University Hospital of Torrejon: collaborator

Study Sites (1)

Torrejón University Hospital

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Related Links

• Study website on RWD catalogues of EMA

MeSH Terms

Conditions

Skin Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study faced three primary limitations. Study duration was extended from 12 to 18 months due to recruitment challenges in community healthcare. The primary outcome (CUS score) was assessed by a small cohort of six specialists, which increased the potential impact of individual outlier responses on the aggregate mean. Additionally, the study design focused on usability and diagnostic capability, excluding longitudinal metrics such as Minimal Detectable Change (MDC).

Results Point of Contact

• Title: Jordi Barrachina - Clinical Affairs Manager
• Organization: AI Labs Group S.L.

jordibarrachina@legit.health

+34 653 08 83 37

Study Officials

• Marta Andreu, MD

  Torrejón University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 1, 2024
• Study Start: March 3, 2022
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2026-02

Locations

ES (1)