Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion (COVIDX_EVCDAO)
Clinical Validation of a Computer-Aided Diagnosis (CAD) System Utilizing Artificial Intelligence Algorithms for Continuous and Remote Monitoring of Patient Condition Severity in an Objective and Stable Manner
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.
Study Overview
Status
Conditions
Detailed Description
Study Overview and Rationale The investigation was designed in response to the COVID-19 pandemic's disruption of dermatology care, which highlighted the need for efficient, remote tools to monitor chronic conditions like psoriasis, eczema, and acne. Current monitoring often relies on subjective human assessment; this study evaluates whether an Artificial Intelligence (AI) tool can provide more objective, continuous data from a participant's home to support clinical decision-making.
Objectives and Hypothesis Primary Objective: To validate the device's ability to reliably track the progression of chronic dermatological conditions. Success is measured by achieving a specific score on the Clinical Utility Questionnaire (CUS).
Secondary Objectives: To confirm high participant satisfaction with remote use, demonstrate a potential reduction in face-to-face consultations, and establish the device as a trustworthy monitoring system.
Hypothesis: The device can perform objective, continuous remote monitoring, increasing participant empowerment and reducing the need for frequent hospital visits.
Research Design and Methodology This is a prospective, observational, and analytical study involving a single group of participants.
Target Population: 160 adult participants (over age 18) diagnosed with chronic skin pathologies, including Psoriasis, Urticaria, Acne, Atopic Dermatitis, and others.
Duration: The total study duration was 18 months, with each participant followed for a 6-month period.
Participant Tasks:
Initial Visit: Participants are recruited, provide informed consent, and receive a study code. They capture their first photographs under medical supervision.
Remote Monitoring: At home, participants use their own smartphones to capture and transmit photos of affected areas at intervals determined by their specialist.
Questionnaires: Participants regularly complete symptoms and quality of life surveys (DLQI) within the app.
Data Quality and Statistical Analysis To ensure the integrity of the findings, the study implemented rigorous quality assurance and statistical protocols.
Quality Assurance and Monitoring
Site Monitoring: A designated independent monitor conducted reviews every 3 months (or every 5 participants) to verify data accuracy and ensure compliance with the Clinical Investigation Plan (CIP) and ISO 14155:2020 standards.
Data Validation: Computer filters automatically identify missing values or inconsistencies, while manual editing is used to detect logical errors.
Source Data Verification (SDV): The sponsor verified anonymized source documents, such as images and clinical records, against the electronic case report forms (CRFs).
Statistical Principles
- Primary Analysis: A one-sample Student's t-test was used to compare the mean CUS scores against the target threshold of 8.0/10.
- Secondary Analysis: Qualitative variables (like "yes/no" survey responses) are analyzed using frequency distributions, while quantitative data are summarized using means, medians, and standard deviations.
- Sample Size: The sample of 6 dermatologists and 160 participants was chosen to minimize observer variability while providing enough cases for a meaningful assessment.
Ethical and Safety Considerations The study adhered to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Data Protection: All participants were assigned alphanumeric codes to ensure anonymity. All data processing complied with GDPR and Spanish data protection laws.
Safety Monitoring: The study tracked Adverse Events (AE) and Serious Adverse Events (SAE). In this investigation, no adverse events or product reactions were observed.
Device Licensing: The manufacturer (AI Labs Group S.L.) provided the device free of charge for the study, but had no access to individual participant accounts or medical information.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid
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Torrejón de Ardoz, Madrid, Spain, 28850
- Torrejón University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinical Utility Questionnaire (CUS) Score
Time Frame: At the conclusion of the study evaluation period, up to 18 months.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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System Usability Scale (SUS) Score
Time Frame: Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
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The System Usability Scale (SUS) is a standardized 10-item survey used to evaluate the usability and learnability of the Legit.Health Plus medical device. Scale Ranges: Each item is rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Calculation Method: To calculate the SUS score, individual item responses are transformed into a 0-4 scale. For odd-numbered items (1, 3, 5, 7, 9), the score is the scale position minus 1. For even-numbered items (2, 4, 6, 8, 10), the score is 5 minus the scale position. The sum of these ten transformed scores is then multiplied by 2.5 to normalize the total result to a 10-point scale. Formula: (Sum of Transformed Item Scores) × 2.5. Interpretation: The final score ranges from 0 to 10. Higher scores indicate better usability. A score of 6.8 or higher is generally considered above average clinical usability. |
Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
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Patient Satisfaction Questionnaire Score
Time Frame: Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
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This 8-item questionnaire assesses user experience and satisfaction with the Legit.Health Plus device for remote monitoring. Scale Ranges: Each of the 8 items (e.g., ease of use, empowerment, and support) is rated on a Likert scale from 0 to 10. For most items, 0 represents the lowest level of satisfaction (e.g., "Very difficult" or "Strongly disagree") and 10 represents the highest (e.g., "Very easy" or "Strongly agree"). Calculation Method: The total score is the arithmetic mean of the responses to the 8 individual items. The sum of all item scores is divided by 8 to produce a single value. Interpretation: The final score ranges from 0 to 10. Higher scores indicate greater patient satisfaction with the remote monitoring system and the care received through the application. |
Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
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Utility Questionnaire (DUQ) Score
Time Frame: Collected once at the end of the 6-month follow-up period for each participant.
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The Data Utility Questionnaire (DUQ) is a standardized 5-item survey used to evaluate the utility of the information provided by the Legit.Health Plus medical device in the clinical consultation. Scale Ranges: Each item is rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Calculation Method: To calculate the DUQ score, individual item responses are transformed into a 0-4 scale. The sum of these five scores is then multiplied by 100 and divided by (5*5) to normalize the total result to a 10-point scale. Formula: (Sum of Transformed Item Scores) × 100/(5*5). Interpretation: The final score ranges from 0 to 100. Higher scores indicate better usability. A score of 6.8 or higher is generally considered above average clinical usability. |
Collected once at the end of the 6-month follow-up period for each participant.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marta Andreu, MD, Torrejón University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LEGIT_COVIDX_EVCDAO_2022
- EUPAS108260 (Other Identifier: European Medicines Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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